HIV InfectionNCT00851799

Impact of Antiretroviral Therapy on Metabolic, Skeletal, and Cardiovascular Parameters

An observational study of HIV Infection, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 26 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infection
What is being tested?: Emtricitabine/tenofovir disoproxil fumarate, Ritonavir and Atazanavir
Type of treatment: Pill or oral medicine
How many people: 334 participants
Where: 26 sitesUnited States
Study dates: Jun 2009to Jun 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Antiretroviral naïve, HIV-infected men and women with HIV-1 RNA level >1000 copies/ml initiating treatment for HIV-1 infection.

Who may be able to join

Enrollment in A5257 and intent to enroll in A5001 (ALLRT)
Signed informed consent
For A5257 inclusion criteria, please see ClinicalTrials.gov identifier NCT00811954

Who cannot join

Diabetes mellitus, (fasting plasma glucose ≥ 126 mg/dL on two occasions or on hypoglycemic medications).
Known cardiovascular disease (history of myocardial infarction [MI], coronary artery bypass graft surgery, percutaneous coronary intervention, stroke, transient ischemic attack, or peripheral arterial disease with ankle-brachial index of less than 0.9 or claudication)
Uncontrolled hypothyroidism or hyperthyroidism which in the opinion of the site investigator would affect substudy participation
Current use of statins, fish oil (greater than 2 grams per day), fibric acid derivatives, or niacin (more than 1000 mg per day) (NOTE: Current use of fish oil and niacin is defined as receiving treatment in the 8 weeks prior to study entry)
Intention to start pharmacological or surgical intervention for weight loss
Use of any ART in the 30 days before study entry
For A5257 exclusion criteria, please see ClinicalTrials.gov identifier NCT00811954

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

United States26 sites

The Ponce de Leon Center
Atlanta, Georgia, 30308
University of Colorado Hospital CRS (6101)
Aurora, Colorado, 80045
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287
Brigham and Women's Hosp. ACTG CRS
Boston, Massachusetts, 02115
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, 02215
Unc Aids Crs
Chapel Hill, North Carolina, 27514
Northwestern University CRS (2701)
Chicago, Illinois, 60611
Rush University Medical Center (2702)
Chicago, Illinois, 60612
University of Cincinnati CRS (2401)
Cincinnati, Ohio, 45267
Case CRS
Cleveland, Ohio, 44106
Metro Health CRS
Cleveland, Ohio, 44109
The Ohio State University AIDS CRS (2301)
Colombus, Ohio, 43210
Duke Univ. Med. Ctr. Adult CRS (1601)
Durham, North Carolina, 27710
Houston AIDS Research Team CRS (31473)
Houston, Texas, 77030
USC CRS
Los Angeles, California, 90033
UCLA CARE Center CRS
Los Angeles, California, 90035
Vanderbilt Therapeutics CRS
Nashville, Tennessee, 37232
NY Univ. HIV/AIDS CRS (401)
New York, New York, 10016
New Jersey Medical School- Adult Clinical Research Ctr. CRS
Newark, New Jersey, 07103
Pitt CRS
Pittsburgh, Pennsylvania, 15213
AIDS Care CRS
Rochester, New York, 14607
University of Rochester ACTG CRS
Rochester, New York, 14642
Ucsf Aids Crs
San Francisco, California, 94110
University of Washington AIDS CRS (1401)
Seattle, Washington, 98104
Washington University CRS (2101)
St Louis, Missouri, 63110
Harbor - UCLA Med. Ctr. CRS
Torrance, California, 90502

Other trials in United States

About this study

Official title: Cardiovascular, Anthropometric, and Skeletal Effects of Antiretroviral Therapy (ART) Initiation With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Plus Atazanavir/Ritonavir (ATV/r), Darunavir/Ritonavir (DRV/r), or Raltegravir (RAL): Metabolic Substudy of A5257

The U.S. Department of Health and Human Services (HHS) guidelines recommend that HIV-infected people who have never received anti-HIV therapy be treated with a triple drug regimen (commonly called combination antiretroviral therapy, cART). Since the introduction of cART, morbidity and mortality among HIV-infected patients has been dramatically reduced. However, metabolic, skeletal, and cardiovascular diseases have been increasingly reported among HIV-infected patients and may be attributable, in part, to the direct effects of cART. Much of our understanding of the development of these diseases, risk factors, and consequences of these disorders has been derived from clinical studies of HIV-infected persons receiving older antiretroviral agents.

A5260s was designed to examine the contributions of HIV-disease related factors and impact of newer antiretroviral drugs on the development of metabolic (such as blood vessels, blood sugar, cholesterol), skeletal, and cardiovascular diseases in people who have never received anti-HIV therapy. A5260s is a prospective substudy of a phase III randomized clinical trial A5257 (see ClinicalTrials.gov identifier: NCT00811954). A5257 was designed to look at different combinations of anti-HIV drugs that do not contain the medication efavirenz (EFV) and how well these drug combinations work to decrease the amount of HIV in the blood and to allow immune system recovery in people who have never received anti-HIV therapy. A5257 also examined drug tolerability and safety for the various drug combinations.

Read the detailed description

A5260s is the optional, metabolic substudy of a phase III, prospective, randomized clinical trial (A5257). For complete details about the parent study A5257, please see ClinicalTrials.gov identifier NCT00811954.

Some participants in study A5257 were asked to participate in substudy A5260s. Not all participants were asked since A5260s only took place at a subset of A5257 sites. Participants who agreed to participate in substudy A5260s were enrolled at the same time as their enrollment in A5257. No interventions were given as part of A5260s, but all A5260s participants underwent blood draws, self-administered questionnaire responses (related to physical activity and body image), ultrasound scans to measure the thickness of the carotid artery in the neck and brachial artery flow mediated dilation in the arm, and computerized topography (CT) and dual-energy x-ray absorptiometry (DEXA) scans to measure bone mineral density and body fat.

The duration of A5260s study was between 2 and 3 years (96 and 144 weeks), depending on when the participant enrolled. The study was designed to enroll a total of 330 participants with at least 110 per a group; each group represented a different randomized drug combination as defined and assigned by the main study A5257.

Cohort A: Atazanavir (ATV) + Ritonavir (RTV) + Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)

Cohort B: Raltegravir (RAL) + FTC/TDF

Cohort C: Darunavir (DRV) + RTV + FTC/TDF

All participants were asked to return for A5260s clinic visits at weeks 4, 24, 48 96 and 144 and participated in all clinical evaluations. No clinical evaluation was restricted to a subset of A5260s participants. If a participant chose to discontinue participation in the substudy, the participant was able to continue in study A5257. However, a participant discontinuing participation from A5257 was also removed from A5260s. Additionally, a participant's decision to discontinue or switch study drugs in the main study did not impact participation and follow-up clinic visits in A5260s.

Conditions: HIV Infection
Being tested: Emtricitabine/tenofovir disoproxil fumarate, Ritonavir, Atazanavir, Raltegravir, Darunavir
Keywords: ART, Antiretroviral therapy, Treatment naive, Highly active antiretroviral therapy (HAART)
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Emtricitabine/tenofovir disoproxil fumarateDrug
200 mg emtricitabine/300 mg tenofovir disoproxil fumarate taken orally daily. A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs).
Other Name: TDF/FTC
RitonavirDrug
100 mg taken orally once daily. A protease inhibitor (PI).
Other Name: RTV
AtazanavirDrug
300 mg taken orally once daily. A protease inhibitor (PI).
Other Name: ATV
RaltegravirDrug
400 mg taken orally twice daily. An integrase inhibitor (INI).
Other Name: RAL
DarunavirDrug
100 mg taken orally once daily. A protease inhibitor (PI).
Other Name: RTV

Study groups in NCT00851799
Study group	Role	What they receive
Cohort A		ATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Receives: Drug: Emtricitabine/tenofovir disoproxil fumarate; Drug: Ritonavir; Drug: Atazanavir
Cohort B		RAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Receives: Drug: Emtricitabine/tenofovir disoproxil fumarate; Drug: Ritonavir; Drug: Raltegravir
Cohort C		DRV/RTV + FTC/TDF FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Receives: Drug: Emtricitabine/tenofovir disoproxil fumarate; Drug: Ritonavir; Drug: Darunavir

What is being measured

The primary outcome is the main question the study is designed to answer.

Annual Rate of Change in Right Common Carotid Artery Intima-media Thickness (CIMT)
Right common carotid artery intima-media thickness was measured by ultrasound scan at study entry and weeks 48, 96 and 144.
The annual rate of change in right common carotid artery intima-media thickness (CIMT) was estimated over 144 weeks from study entry using mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors.
Measured: Study entry, week 144
Change in Brachial Artery (BA) Flow Mediated Dilation (FMD) From Study Entry to Week 24
Brachial artery flow mediated dilation was measured by brachial artery reactivity tests. All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments.
The change from study entry to week 24 in brachial artery FMD (%) was defined as the maximum FMD (%) calculated from resting heart rate (RH) 60 seconds and RH 90 seconds, relative to resting brachial artery diameter.
Measured: Study entry, week 24

Secondary outcomes (25)

Change in Brachial Artery Flow Mediated Dilation (FMD) From Study Entry to Weeks 4 and 48
Brachial artery flow mediated dilation was measured by brachial artery reactivity tests. All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments.
The change from study entry to weeks 4 and 48 in brachial artery FMD (%) was defined as the maximum FMD (%) calculated from resting heart rate (RH) 60 seconds and RH 90 seconds, relative to resting brachial artery diameter.
Measured: Study entry, weeks 4 and 48
Change in Absolute Flow Mediated Dilation (FMD) From Study Entry to Weeks 4, 24 and 48
The change in absolute FMD was defined as the maximum absolute FMD from the RH 60 and 90 second measurements, from study entry to weeks 4, 24, and 48 (unit of measure millimeters). All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments.
Measured: Study entry, weeks 4, 24 and 48
Percent Change in Bone Mineral Density (BMD) of the Hip From Study Entry to Week 96
Bone mineral density (BMD) of the hip was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.
Measured: Study entry, week 96
Percent Change in Bone Mineral Density (BMD) of the Lumber Spine From Study Entry to Week 96
Bone mineral density (BMD) of the lumber spine was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.
Measured: Study entry, week 96
Percent Change in Bone Mineral Density (BMD) of the Total Body From Study Entry to Week 96
Bone mineral density (BMD) of the total body was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.
Measured: Study entry, week 96
Percent Change in Total Limb Fat From Study Entry to Week 96
Total limb fat was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.
Measured: Study entry, week 96
Percent Change in Trunk Fat From Study Entry to Week 96
Trunk fat was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.
Measured: Study entry, week 96
Percent Change in Lean Mass From Study Entry to Week 96
Lean mass was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.
Measured: Study entry, week 96
Percent Change in Visceral Abdominal Fat (VAT) From Study Entry to Week 96
Visceral abdominal fat (VAT) was evaluated by single slice abdominal computerized tomography scans at study entry and week 96. The percent change was calculated as as ((week 96 value - study entry value) / study entry value)) x 100.
Measured: Study entry, week 96
Percent Change in Subcutaneous Abdominal Fat (SAT) From Study Entry to Week 96
Subcutaneous abdominal fat (SAT) was evaluated by single slice abdominal computerized tomography scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.
Measured: Study entry, week 96
CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144
The absolute levels of CD4+ T-cell counts (cells/mm^3) measured at study entry and weeks 24, 48, 96 and 144.
Measured: Study entry, weeks 24, 48, 96 and 144
Change in CD4+ T-cell Count From Study Entry to Weeks 24, 48, 96 and 144
Change was calculated as (CD4+ T-cell count at week 24, 48, 96, or 144) - (CD4+ T-cell count at study entry).
Measured: Study entry to weeks 24, 48, 96, and 144
Change in Fasting Total Cholesterol (TC) From Study Entry to Weeks 4, 24, 48 and 96
Total cholesterol (TC, unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in TC was calculated as (week 4, 24, 48 or 96 result) - (study entry result).
Measured: Study entry, weeks 4, 24, 48 and 96
Change in Fasting Triglyceride (TG) From Study Entry to Weeks 4, 24, 48 and 96
Triglyceride (TG, unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in TG was calculated as (week 4, 24, 48 or 96 result) - (study entry result).
Measured: Study entry, weeks 4, 24, 48 and 96
Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Study Entry to Weeks 4, 24, 48 and 96
HDL cholesterol (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in HDL-C was calculated as (week 4, 24, 48 or 96 result) - (study entry result).
Measured: Study entry, weeks 4, 24, 48 and 96
Change in Fasting Calculated Low-density Lipoprotein Cholesterol (LDL-C) From Study Entry to Weeks 4, 24, 48 and 96
Calculated LDL-C (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in calculated LDL-C was calculated as (week 4, 24, 48 or 96 result) - (study entry result).
Measured: Study entry, weeks 4, 24, 48 and 96
Change in Fasting Glucose Level From Study Entry to Weeks 4, 24, 48 and 96
Glucose (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96; all results reflect measures captured from participants who reported fasting for at least 8 hours prior to assessment. Change was calculated as (fasting result during at week 4, 24, 48 or 96) - (fasting result at study entry).
Measured: Study entry, weeks 4, 24, 48 and 96
Change in Fasting Insulin Level From Study Entry to Weeks 4, 24, 48 and 96
Insulin (unit of measure uIU/dL) was measured at study entry and weeks 4, 24, 48 and 96; all results reflect measures captured from participants who reported fasting for at least 8 hours prior to assessment. Change was calculated as (fasting result during at week 4, 24, 48 or 96) - (fasting result at study entry).
Measured: Study entry, weeks 4, 24, 48 and 96
Fold Change in D-dimer From Study Entry to Weeks 48 and 96
D-dimer was measured at study entry and weeks 48 and 96 (unit of measure ug/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay.
Measured: Study entry, weeks 48 and 96
Fold Change in High Sensitivity C-reactive Protein (hsCRP) From Study Entry to Weeks 48 and 96
hsCRP was measured at study entry and weeks 48 and 96 (unit of measure ug/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay.
Measured: Study entry, weeks 48 and 96
Fold Change in Interleukin-6 (IL-6) From Study Entry to Weeks 48 and 96
IL-6 was measured at study entry and weeks 48 and 96 (unit of measure pg/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay.
Measured: Study entry, weeks 48 and 96
Fold Change in Soluble CD14 From Study Entry to Weeks 48 and 96
Soluble CD14 was measured at study entry and weeks 48 and 96 (unit of measure ng/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay.
Measured: Study entry, weeks 48 and 96
Fold Change in Soluble CD163 From Study Entry to Weeks 48 and 96
Soluble CD163 was measured at study entry and weeks 48 and 96 (unit of measure ng/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay.
Measured: Study entry, weeks 48 and 96
Fold Change in Percent Expression of CD38+HLADR+ on CD4+ (Percent) From Study Entry to Weeks 24 and 96
Percent expression of CD38+HLADR+ on CD4+ was measured at study entry and weeks 24 and 96 (unit of measure percent). Fold change from study entry to week 24 or week 96 was calculated as (week 24 value or week 96 value) / (study entry value).
Measured: Study entry, weeks 24 and 96
Fold Change in Percent Expression of CD38+HLADR+ on CD8+ (Percent) From Study Entry to Weeks 24 and 96
Percent expression of CD38+HLADR+ on CD8+ was measured at study entry and weeks 24 and 96 (unit of measure percent). Fold change from study entry to week 24 or week 96 was calculated as (week 24 value or week 96 value) / (study entry value).
Measured: Study entry, weeks 24 and 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Jun 2013

First posted26 Feb 2009 (estimated)
Study startJun 2009
Primary completionJun 2013
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (11)Papers the sponsor has linked to this study.
Other trials for HIV InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 334 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00851799
Sponsor's protocol ID: ACTG A5260s
Other IDs: 1U01AI068636, ACTG A5257 metabolic substudy
Status last verified: Dec 2015
First submitted: 24 Feb 2009
Last updated: 13 Jan 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Lennox JL, Landovitz RJ, Ribaudo HJ, Ofotokun I, Na LH, Godfrey C, Kuritzkes DR, Sagar M, Brown TT, Cohn SE, McComsey GA, Aweeka F, Fichtenbaum CJ, Presti RM, Koletar SL, Haas DW, Patterson KB, Benson CA, Baugh BP, Leavitt RY, Rooney JF, Seekins D, Currier JS; ACTG A5257 Team. Efficacy and tolerability of 3 nonnucleoside reverse transcriptase inhibitor-sparing antiretroviral regimens for treatment-naive volunteers infected with HIV-1: a randomized, controlled equivalence trial. Ann Intern Med. 2014 Oct 7;161(7):461-71. doi: 10.7326/M14-1084.
PubMed 25285539
Ofotokun I, Na LH, Landovitz RJ, Ribaudo HJ, McComsey GA, Godfrey C, Aweeka F, Cohn SE, Sagar M, Kuritzkes DR, Brown TT, Patterson KB, Para MF, Leavitt RY, Villasis-Keever A, Baugh BP, Lennox JL, Currier JS; AIDS Clinical Trials Group (ACTG) A5257 Team. Comparison of the metabolic effects of ritonavir-boosted darunavir or atazanavir versus raltegravir, and the impact of ritonavir plasma exposure: ACTG 5257. Clin Infect Dis. 2015 Jun 15;60(12):1842-51. doi: 10.1093/cid/civ193. Epub 2015 Mar 12.
PubMed 25767256
Vardhanabhuti S, Ribaudo HJ, Landovitz RJ, Ofotokun I, Lennox JL, Currier JS, Olson LM, Haas DW. Screening for UGT1A1 Genotype in Study A5257 Would Have Markedly Reduced Premature Discontinuation of Atazanavir for Hyperbilirubinemia. Open Forum Infect Dis. 2015 Jul 1;2(3):ofv085. doi: 10.1093/ofid/ofv085. eCollection 2015 Sep.
PubMed 26180834
Stein JH, Ribaudo HJ, Hodis HN, Brown TT, Tran TT, Yan M, Brodell EL, Kelesidis T, McComsey GA, Dube MP, Murphy RL, Currier JS. A prospective, randomized clinical trial of antiretroviral therapies on carotid wall thickness. AIDS. 2015 Sep 10;29(14):1775-83. doi: 10.1097/QAD.0000000000000762.
PubMed 26372383
Kelesidis T, Tran TT, Stein JH, Brown TT, Moser C, Ribaudo HJ, Dube MP, Murphy R, Yang OO, Currier JS, McComsey GA. Changes in Inflammation and Immune Activation With Atazanavir-, Raltegravir-, Darunavir-Based Initial Antiviral Therapy: ACTG 5260s. Clin Infect Dis. 2015 Aug 15;61(4):651-60. doi: 10.1093/cid/civ327. Epub 2015 Apr 22.
PubMed 25904376
Brown TT, Moser C, Currier JS, Ribaudo HJ, Rothenberg J, Kelesidis T, Yang O, Dube MP, Murphy RL, Stein JH, McComsey GA. Changes in Bone Mineral Density After Initiation of Antiretroviral Treatment With Tenofovir Disoproxil Fumarate/Emtricitabine Plus Atazanavir/Ritonavir, Darunavir/Ritonavir, or Raltegravir. J Infect Dis. 2015 Oct 15;212(8):1241-9. doi: 10.1093/infdis/jiv194. Epub 2015 May 5.
PubMed 25948863
Stein JH, Brown TT, Ribaudo HJ, Chen Y, Yan M, Lauer-Brodell E, McComsey GA, Dube MP, Murphy RL, Hodis HN, Currier JS. Ultrasonographic measures of cardiovascular disease risk in antiretroviral treatment-naive individuals with HIV infection. AIDS. 2013 Mar 27;27(6):929-937. doi: 10.1097/QAD.0b013e32835ce27e.
PubMed 23196938
Brown TT, Chen Y, Currier JS, Ribaudo HJ, Rothenberg J, Dube MP, Murphy R, Stein JH, McComsey GA. Body composition, soluble markers of inflammation, and bone mineral density in antiretroviral therapy-naive HIV-1-infected individuals. J Acquir Immune Defic Syndr. 2013 Jul 1;63(3):323-30. doi: 10.1097/QAI.0b013e318295eb1d.
PubMed 23591634
Hughey CM, Vuong BW, Ribaudo HB, Mitchell CCK, Korcarz CE, Hodis HN, Currier JS, Stein JH. Grayscale Ultrasound Texture Features of Carotid and Brachial Arteries in People With HIV Infection Before and After Antiretroviral Therapy. J Am Heart Assoc. 2022 Mar;11(5):e024142. doi: 10.1161/JAHA.121.024142. Epub 2022 Feb 18.
PubMed 35179037
Debroy P, Lake JE, Moser C, Olefsky M, Erlandson KM, Scherzinger A, Stein JH, Currier JS, Brown TT, McComsey GA. Antiretroviral Therapy Initiation Is Associated With Decreased Visceral and Subcutaneous Adipose Tissue Density in People Living With Human Immunodeficiency Virus. Clin Infect Dis. 2021 Mar 15;72(6):979-986. doi: 10.1093/cid/ciaa196.
PubMed 32107532
McComsey GA, Moser C, Currier J, Ribaudo HJ, Paczuski P, Dube MP, Kelesidis T, Rothenberg J, Stein JH, Brown TT. Body Composition Changes After Initiation of Raltegravir or Protease Inhibitors: ACTG A5260s. Clin Infect Dis. 2016 Apr 1;62(7):853-62. doi: 10.1093/cid/ciw017. Epub 2016 Jan 20.
PubMed 26797215

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

All HIV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cardiovascular, Anthropometric, and Skeletal Effects of Antiretroviral Therapy (ART) Initiation With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Plus Atazanavir/Ritonavir (ATV/r), Darunavir/Ritonavir (DRV/r), or Raltegravir (RAL): Metabolic Substudy of A5257
ClinicalTrials.gov ID: NCT00851799
Acronym / sponsor ID: ACTG A5260s
Conditions: HIV Infection
Keywords: ART, Antiretroviral therapy, Treatment naive, Highly active antiretroviral therapy (HAART)
Study type: Observational
Recruitment status: Completed
Enrolment: 334 participants (actual)
Lead sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsResearch network
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Study start: Jun 2009
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 26 Feb 2009 (estimated)
Results: Posted 13 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Cohort A: Atazanavir (ATV) + Ritonavir (RTV) + Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)

Cohort B: Raltegravir (RAL) + FTC/TDF

Cohort C: Darunavir (DRV) + RTV + FTC/TDF

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Cohort A	–	Drug: Emtricitabine/tenofovir disoproxil fumarate, Drug: Ritonavir, Drug: AtazanavirATV/RTV + FTC/TDF Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.
Cohort B	–	Drug: Emtricitabine/tenofovir disoproxil fumarate, Drug: Ritonavir, Drug: RaltegravirRAL + FTC/TDF FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.
Cohort C	–	Drug: Emtricitabine/tenofovir disoproxil fumarate, Drug: Ritonavir, Drug: DarunavirDRV/RTV + FTC/TDF FTC/TDF, darunavir (DRV), and RTV, orally, once daily.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Antiretroviral naïve, HIV-infected men and women with HIV-1 RNA level >1000 copies/ml initiating treatment for HIV-1 infection.

Key inclusion criteria (3 listed)

Enrollment in A5257 and intent to enroll in A5001 (ALLRT)
Signed informed consent
For A5257 inclusion criteria, please see ClinicalTrials.gov identifier NCT00811954

Key exclusion criteria (7 listed)

Diabetes mellitus, (fasting plasma glucose ≥ 126 mg/dL on two occasions or on hypoglycemic medications).
Known cardiovascular disease (history of myocardial infarction [MI], coronary artery bypass graft surgery, percutaneous coronary intervention, stroke, transient ischemic attack, or peripheral arterial disease with ankle-brachial index of less than 0.9 or claudication)
Uncontrolled hypothyroidism or hyperthyroidism which in the opinion of the site investigator would affect substudy participation
Current use of statins, fish oil (greater than 2 grams per day), fibric acid derivatives, or niacin (more than 1000 mg per day) (NOTE: Current use of fish oil and niacin is defined as receiving treatment in the 8 weeks prior to study entry)
Intention to start pharmacological or surgical intervention for weight loss

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Emtricitabine/tenofovir disoproxil fumarate200 mg emtricitabine/300 mg tenofovir disoproxil fumarate taken orally daily. A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs). Other Name: TDF/FTC	Drug	Cohort A, Cohort B, Cohort C
Ritonavir100 mg taken orally once daily. A protease inhibitor (PI). Other Name: RTV	Drug	Cohort A, Cohort B, Cohort C
Atazanavir300 mg taken orally once daily. A protease inhibitor (PI). Other Name: ATV	Drug	Cohort A
Raltegravir400 mg taken orally twice daily. An integrase inhibitor (INI). Other Name: RAL	Drug	Cohort B
Darunavir100 mg taken orally once daily. A protease inhibitor (PI). Other Name: RTV	Drug	Cohort C

Primary outcome

Annual Rate of Change in Right Common Carotid Artery Intima-media Thickness (CIMT)
Time frame: Study entry, week 144
Right common carotid artery intima-media thickness was measured by ultrasound scan at study entry and weeks 48, 96 and 144. The annual rate of change in right common carotid artery intima-media thickness (CIMT) was estimated over 144 weeks from study entry using mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors.
Change in Brachial Artery (BA) Flow Mediated Dilation (FMD) From Study Entry to Week 24
Time frame: Study entry, week 24
Brachial artery flow mediated dilation was measured by brachial artery reactivity tests. All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments. The change from study entry to week 24 in brachial artery FMD (%) was defined as the maximum FMD (%) calculated from resting heart rate (RH) 60 seconds and RH 90 seconds, relative to resting brachial artery diameter.

25 secondary outcomes

Change in Brachial Artery Flow Mediated Dilation (FMD) From Study Entry to Weeks 4 and 48
Time frame: Study entry, weeks 4 and 48
Change in Absolute Flow Mediated Dilation (FMD) From Study Entry to Weeks 4, 24 and 48
Time frame: Study entry, weeks 4, 24 and 48
Percent Change in Bone Mineral Density (BMD) of the Hip From Study Entry to Week 96
Time frame: Study entry, week 96
Percent Change in Bone Mineral Density (BMD) of the Lumber Spine From Study Entry to Week 96
Time frame: Study entry, week 96
Percent Change in Bone Mineral Density (BMD) of the Total Body From Study Entry to Week 96
Time frame: Study entry, week 96
Percent Change in Total Limb Fat From Study Entry to Week 96
Time frame: Study entry, week 96
Percent Change in Trunk Fat From Study Entry to Week 96
Time frame: Study entry, week 96
Percent Change in Lean Mass From Study Entry to Week 96
Time frame: Study entry, week 96
Percent Change in Visceral Abdominal Fat (VAT) From Study Entry to Week 96
Time frame: Study entry, week 96
Percent Change in Subcutaneous Abdominal Fat (SAT) From Study Entry to Week 96
Time frame: Study entry, week 96
CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144
Time frame: Study entry, weeks 24, 48, 96 and 144
Change in CD4+ T-cell Count From Study Entry to Weeks 24, 48, 96 and 144
Time frame: Study entry to weeks 24, 48, 96, and 144
Change in Fasting Total Cholesterol (TC) From Study Entry to Weeks 4, 24, 48 and 96
Time frame: Study entry, weeks 4, 24, 48 and 96
Change in Fasting Triglyceride (TG) From Study Entry to Weeks 4, 24, 48 and 96
Time frame: Study entry, weeks 4, 24, 48 and 96
Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Study Entry to Weeks 4, 24, 48 and 96
Time frame: Study entry, weeks 4, 24, 48 and 96
Change in Fasting Calculated Low-density Lipoprotein Cholesterol (LDL-C) From Study Entry to Weeks 4, 24, 48 and 96
Time frame: Study entry, weeks 4, 24, 48 and 96
Change in Fasting Glucose Level From Study Entry to Weeks 4, 24, 48 and 96
Time frame: Study entry, weeks 4, 24, 48 and 96
Change in Fasting Insulin Level From Study Entry to Weeks 4, 24, 48 and 96
Time frame: Study entry, weeks 4, 24, 48 and 96
Fold Change in D-dimer From Study Entry to Weeks 48 and 96
Time frame: Study entry, weeks 48 and 96
Fold Change in High Sensitivity C-reactive Protein (hsCRP) From Study Entry to Weeks 48 and 96
Time frame: Study entry, weeks 48 and 96
Fold Change in Interleukin-6 (IL-6) From Study Entry to Weeks 48 and 96
Time frame: Study entry, weeks 48 and 96
Fold Change in Soluble CD14 From Study Entry to Weeks 48 and 96
Time frame: Study entry, weeks 48 and 96
Fold Change in Soluble CD163 From Study Entry to Weeks 48 and 96
Time frame: Study entry, weeks 48 and 96
Fold Change in Percent Expression of CD38+HLADR+ on CD4+ (Percent) From Study Entry to Weeks 24 and 96
Time frame: Study entry, weeks 24 and 96
Fold Change in Percent Expression of CD38+HLADR+ on CD8+ (Percent) From Study Entry to Weeks 24 and 96
Time frame: Study entry, weeks 24 and 96

Results and safety

Results posted to the registry on 13 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort A: ATV/RTV + FTC/TDF	109	93
Cohort B: RAL + FTC/TDF	106	93
Cohort C: DRV/RTV + FTC/TDF	113	89

Primary outcome: Annual Rate of Change in Right Common Carotid Artery Intima-media Thickness (CIMT)

Time frame: Study entry, week 144. Mean (95% Confidence Interval). Unit: micron/year

Measure	Cohort A: ATV/RTV + FTC/TDF n = 109	Cohort B: RAL + FTC/TDF n = 106	Cohort C: DRV/RTV + FTC/TDF n = 113
Value	8.2 (5.6 to 10.8)	10.7 (9.2 to 12.2)	12.9 (10.3 to 15.5)

Cohort A: ATV/RTV + FTC/TDF vs Cohort C: DRV/RTV + FTC/TDF: Difference in annual rate of change: -4.7 (97.5% CI -8.9 to -0.4), p = 0.013, Mixed Models Analysis
Cohort A: ATV/RTV + FTC/TDF vs Cohort B: RAL + FTC/TDF: Difference in annual rate of change: -2.8 (97.5% CI -7.0 to 1.5), p = 0.15, Mixed Models Analysis
Cohort B: RAL + FTC/TDF vs Cohort C: DRV/RTV + FTC/TDF: Difference in annual rate of change: 1.9 (97.5% CI -2.4 to 6.2), p = 0.31, Mixed Models Analysis

Population analysed: Intention to treat; all eligible participants were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.

Primary outcome: Change in Brachial Artery (BA) Flow Mediated Dilation (FMD) From Study Entry to Week 24

Time frame: Study entry, week 24. Median (Inter-Quartile Range). Unit: percent

Measure	Cohort A: ATV/RTV + FTC/TDF n = 103	Cohort B: RAL + FTC/TDF n = 102	Cohort C: DRV/RTV + FTC/TDF n = 107
Value	-0.05 (-1.51 to 1.60)	-0.27 (-1.61 to 1.55)	0.15 (-1.39 to 1.56)

Cohort A: ATV/RTV + FTC/TDF vs Cohort C: DRV/RTV + FTC/TDF: Difference in Change: 0.24 (97.5% CI -0.63 to 1.11), p = 0.53, Regression, Linear
Cohort A: ATV/RTV + FTC/TDF vs Cohort B: RAL + FTC/TDF vs Cohort C: DRV/RTV + FTC/TDF: Difference in Change (%): -0.21 (97.5% CI -0.98 to 0.55), p = 0.53, Regression, Linear

Population analysed: Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.

25 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort A: ATV/RTV + FTC/TDF	0 of 0	0 of 0	Not reported
Cohort B: RAL + FTC/TDF	0 of 0	0 of 0	Not reported
Cohort C: DRV/RTV + FTC/TDF	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25285539Lennox JL, Landovitz RJ, Ribaudo HJ, Ofotokun I, Na LH, Godfrey C, Kuritzkes DR, Sagar M, Brown TT, Cohn SE, McComsey GA, Aweeka F, Fichtenbaum CJ, Presti RM, Koletar SL, Haas DW, Patterson KB, Benson CA, Baugh BP, Leavitt RY, Rooney JF, Seekins D, Currier JS; ACTG A5257 Team. Efficacy and tolerability of 3 nonnucleoside reverse transcriptase inhibitor-sparing antiretroviral regimens for treatment-naive volunteers infected with HIV-1: a randomized, controlled equivalence trial. Ann Intern Med. 2014 Oct 7;161(7):461-71. doi: 10.7326/M14-1084.
Background: PubMed 25767256Ofotokun I, Na LH, Landovitz RJ, Ribaudo HJ, McComsey GA, Godfrey C, Aweeka F, Cohn SE, Sagar M, Kuritzkes DR, Brown TT, Patterson KB, Para MF, Leavitt RY, Villasis-Keever A, Baugh BP, Lennox JL, Currier JS; AIDS Clinical Trials Group (ACTG) A5257 Team. Comparison of the metabolic effects of ritonavir-boosted darunavir or atazanavir versus raltegravir, and the impact of ritonavir plasma exposure: ACTG 5257. Clin Infect Dis. 2015 Jun 15;60(12):1842-51. doi: 10.1093/cid/civ193. Epub 2015 Mar 12.
Background: PubMed 26180834Vardhanabhuti S, Ribaudo HJ, Landovitz RJ, Ofotokun I, Lennox JL, Currier JS, Olson LM, Haas DW. Screening for UGT1A1 Genotype in Study A5257 Would Have Markedly Reduced Premature Discontinuation of Atazanavir for Hyperbilirubinemia. Open Forum Infect Dis. 2015 Jul 1;2(3):ofv085. doi: 10.1093/ofid/ofv085. eCollection 2015 Sep.
Results publication: PubMed 26372383Stein JH, Ribaudo HJ, Hodis HN, Brown TT, Tran TT, Yan M, Brodell EL, Kelesidis T, McComsey GA, Dube MP, Murphy RL, Currier JS. A prospective, randomized clinical trial of antiretroviral therapies on carotid wall thickness. AIDS. 2015 Sep 10;29(14):1775-83. doi: 10.1097/QAD.0000000000000762.
Results publication: PubMed 25904376Kelesidis T, Tran TT, Stein JH, Brown TT, Moser C, Ribaudo HJ, Dube MP, Murphy R, Yang OO, Currier JS, McComsey GA. Changes in Inflammation and Immune Activation With Atazanavir-, Raltegravir-, Darunavir-Based Initial Antiviral Therapy: ACTG 5260s. Clin Infect Dis. 2015 Aug 15;61(4):651-60. doi: 10.1093/cid/civ327. Epub 2015 Apr 22.
Results publication: PubMed 25948863Brown TT, Moser C, Currier JS, Ribaudo HJ, Rothenberg J, Kelesidis T, Yang O, Dube MP, Murphy RL, Stein JH, McComsey GA. Changes in Bone Mineral Density After Initiation of Antiretroviral Treatment With Tenofovir Disoproxil Fumarate/Emtricitabine Plus Atazanavir/Ritonavir, Darunavir/Ritonavir, or Raltegravir. J Infect Dis. 2015 Oct 15;212(8):1241-9. doi: 10.1093/infdis/jiv194. Epub 2015 May 5.
Results publication: PubMed 23196938Stein JH, Brown TT, Ribaudo HJ, Chen Y, Yan M, Lauer-Brodell E, McComsey GA, Dube MP, Murphy RL, Hodis HN, Currier JS. Ultrasonographic measures of cardiovascular disease risk in antiretroviral treatment-naive individuals with HIV infection. AIDS. 2013 Mar 27;27(6):929-937. doi: 10.1097/QAD.0b013e32835ce27e.
Results publication: PubMed 23591634Brown TT, Chen Y, Currier JS, Ribaudo HJ, Rothenberg J, Dube MP, Murphy R, Stein JH, McComsey GA. Body composition, soluble markers of inflammation, and bone mineral density in antiretroviral therapy-naive HIV-1-infected individuals. J Acquir Immune Defic Syndr. 2013 Jul 1;63(3):323-30. doi: 10.1097/QAI.0b013e318295eb1d.
Derived from this study: PubMed 35179037Hughey CM, Vuong BW, Ribaudo HB, Mitchell CCK, Korcarz CE, Hodis HN, Currier JS, Stein JH. Grayscale Ultrasound Texture Features of Carotid and Brachial Arteries in People With HIV Infection Before and After Antiretroviral Therapy. J Am Heart Assoc. 2022 Mar;11(5):e024142. doi: 10.1161/JAHA.121.024142. Epub 2022 Feb 18.
Derived from this study: PubMed 32107532Debroy P, Lake JE, Moser C, Olefsky M, Erlandson KM, Scherzinger A, Stein JH, Currier JS, Brown TT, McComsey GA. Antiretroviral Therapy Initiation Is Associated With Decreased Visceral and Subcutaneous Adipose Tissue Density in People Living With Human Immunodeficiency Virus. Clin Infect Dis. 2021 Mar 15;72(6):979-986. doi: 10.1093/cid/ciaa196.
Derived from this study: PubMed 26797215McComsey GA, Moser C, Currier J, Ribaudo HJ, Paczuski P, Dube MP, Kelesidis T, Rothenberg J, Stein JH, Brown TT. Body Composition Changes After Initiation of Raltegravir or Protease Inhibitors: ACTG A5260s. Clin Infect Dis. 2016 Apr 1;62(7):853-62. doi: 10.1093/cid/ciw017. Epub 2016 Jan 20.

Related trials for HIV Infection

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Todd Brown, MD, PhD study chair

Johns Hopkins University

James Stein, MD study chair

University of Wisconsin, Madison

Grace McComsey, MD, FIDSA study chair

University Hospitals Cleveland Medical Center

26 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infection, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 26 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annual Rate of Change in Right Common Carotid Artery Intima-media Thickness (CIMT) (time frame: Study entry, week 144). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00851799, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2016.