AzTrials
AzTrials

HIV InfectionsNCT00001137

Long-Term Data Collection From Participants in Adult AIDS Clinical Trials

An observational study of HIV Infections, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 77 sites in 2 countries.

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

The purpose of this study is to determine what combinations of anti-HIV drugs work best in patients treated over several years. The study will also assess the occurrence of side effects and opportunistic infections in patients with low viral loads compared to those with higher viral loads. Read more about this study

Who is it for?
Ages 13 years and older
Conditions the study is for
HIV Infections
How many people
5,982 participants
Where
77 sitesin 2 countries
Study dates
Jan 2000to Nov 2013
Phase
Observational
Are there results?
None posted in the registry

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 13 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Participants in this study will be HIV-infected men and women who are enrolled in an ACTG parent study and are receiving HAART.

Who may be able to join

  • HIV-1 infected
  • Enrolled in an AIDS Clinical Trial Group (ACTG) parent study and has enrolled in this study on or before the Week 16 visit of the parent study, including the visit window of the parent study. More information on this criterion can be found in the protocol.
  • Willing to provide consent for the release and use of clinical data from the parent study
  • Life expectancy of at least 24 weeks
  • Parent or guardian willing to provide informed consent, if applicable

Who cannot join

  • Active alcohol or drug abuse that may interfere with the study

Trial locations and contacts

77 sites in 2 countries.

77 sites in 2 countries

United States75 sites

  • Emory Univ

    Atlanta, Georgia, 30308

  • Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr

    Atlanta, Georgia, 303652225

  • IHV Baltimore Treatment CRS

    Baltimore, Maryland, 21201

  • Johns Hopkins Hosp

    Baltimore, Maryland, 21287

  • Univ of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Harvard (Massachusetts Gen Hosp)

    Boston, Massachusetts, 02114

  • Brigham and Women's Hosp

    Boston, Massachusetts, 02115

  • Boston Med Ctr

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess - West Campus

    Boston, Massachusetts, 02215

  • SUNY / Erie County Med Ctr at Buffalo

    Buffalo, New York, 14215

  • Cooper Univ. Hosp. CRS

    Camden, New Jersey, 08103

  • Wake County Department of Health

    Chapel Hill, North Carolina, 27514

  • Univ of North Carolina

    Chapel Hill, North Carolina, 275997215

  • Carolinas Med Ctr

    Charlotte, North Carolina, 28203

  • Northwestern Univ Med School

    Chicago, Illinois, 60611

  • Cook County Hosp

    Chicago, Illinois, 60612

  • Rush Presbyterian - Saint Luke's Med Ctr

    Chicago, Illinois, 60612

  • Univ of Cincinnati

    Cincinnati, Ohio, 452670405

  • Cleveland Clinic

    Cleveland, Ohio, 44106-5083

  • MetroHealth Med Ctr

    Cleveland, Ohio, 441091998

  • Ohio State Univ Hosp Clinic

    Columbus, Ohio, 432101228

  • Peabody Health Center CRS

    Dallas, Texas, 75215

  • Univ of Texas, Southwestern Med Ctr of Dallas

    Dallas, Texas, 75390

  • Denver Public Health CRS

    Denver, Colorado, 80204

  • Univ of Colorado Health Sciences Ctr

    Denver, Colorado, 80262

  • Wayne State Univ. CRS

    Detroit, Michigan, 48201

  • Duke Univ Med Ctr

    Durham, North Carolina, 27710

  • Moses H Cone Memorial Hosp

    Greensboro, North Carolina, 27401

  • Univ of Hawaii

    Honolulu, Hawaii, 96816

  • Houston AIDS Research Team CRS

    Houston, Texas, 77030

  • Indiana Univ Hosp

    Indianapolis, Indiana, 462025250

  • Division of Inf Diseases/ Indiana Univ Hosp

    Indianapolis, Indiana, 46202

  • Methodist Hosp of Indiana / Life Care Clinic

    Indianapolis, Indiana, 46202

  • Univ of Iowa Hosp and Clinic

    Iowa City, Iowa, 52242

  • Kaiser Permanente LAMC

    Los Angeles, California, 90027

  • Univ of Southern California / LA County USC Med Ctr

    Los Angeles, California, 900331079

  • UCLA CARE Ctr

    Los Angeles, California, 90095

  • Willow Clinic

    Menlo Park, California, 94025

  • Univ of Miami School of Medicine

    Miami, Florida, 331361013

  • Hennepin County Medical Clinic

    Minneapolis, Minnesota, 55415

  • Univ of Minnesota

    Minneapolis, Minnesota, 55455

  • Vanderbilt Univ Med Ctr

    Nashville, Tennessee, 37203

  • Tulane Med Ctr Hosp

    New Orleans, Louisiana, 70112

  • Beth Israel Med Ctr

    New York, New York, 10003

  • Bellevue Hosp / New York Univ Med Ctr

    New York, New York, 10016

  • NY Univ. HIV/AIDS CRS

    New York, New York, 10016

  • Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ

    New York, New York, 10021

  • Chelsea Ctr

    New York, New York, 10021

  • Cornell Univ Med Ctr

    New York, New York, 10021

  • Mount Sinai Med Ctr

    New York, New York, 10029

  • Columbia Presbyterian Med Ctr

    New York, New York, 10032

  • New Jersey Medical School- Adult Clinical Research Ctr. CRS

    Newark, New Jersey, 07103

  • Presbyterian Medical Center - Univ. of PA

    Norristown, Pennsylvania, 19401

  • Univ of Nebraska Med Ctr

    Omaha, Nebraska, 681985130

  • Univ of Pennsylvania at Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Univ of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • The Research & Education Group-Portland CRS

    Portland, Oregon, 97210

  • Virginia Commonwealth Univ. Medical Ctr. CRS

    Richmond, Virginia, 23219

  • AIDS Care CRS

    Rochester, New York, 14607

  • Community Health Network Inc

    Rochester, New York, 14642

  • Univ of Rochester Medical Center

    Rochester, New York, 14642

  • UC Davis Med Ctr

    Sacramento, California, 95814

  • Univ of California / San Diego Treatment Ctr

    San Diego, California, 921036325

  • Univ of California, San Francisco/San Francisco General Hosp

    San Francisco, California, 94110

  • Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium

    San Jose, California, 951282699

  • Marin County Specialty Clinic

    San Rafael, California, 94903

  • Univ of Washington

    Seattle, Washington, 98104

  • St Louis Regional Hosp / St Louis Regional Med Ctr

    St Louis, Missouri, 63112

  • San Mateo AIDS Program / Stanford Univ

    Stanford, California, 943055107

  • Stanford Univ Med Ctr

    Stanford, California, 943055107

  • Bronx-Lebanon Hosp. Ctr. CRS

    The Bronx, New York, 10457

  • Harbor UCLA Med Ctr

    Torrance, California, 90502

  • Tripler Army Med Ctr

    Tripler AMC, Hawaii, 96859

  • Georgetown Univ Med Ctr

    Washington D.C., District of Columbia, 20007

  • Julio Arroyo

    West Columbia, South Carolina, 29169

Other trials in United States

Puerto Rico2 sites

  • Puerto Rico-AIDS CRS

    San Juan, 00935

  • Univ of Puerto Rico

    San Juan, 009365067

Other trials in Puerto Rico

About this study

Official title: Adult AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT) Protocol

The purpose of this study is to determine what combinations of anti-HIV drugs work best in patients treated over several years. The study will also assess the occurrence of side effects and opportunistic infections in patients with low viral loads compared to those with higher viral loads.

Read the detailed description

A compilation of outcomes of various antiretroviral therapies would be beneficial when evaluating which strategies are most effective in long-term treatment of HIV-1. Using data from present and recently completed studies, this study will collect information on therapies and their control of HIV infection and maintenance of durable suppression of HIV-1 replication.

No treatment is provided by this study, but patients will continue to receive highly active antiretroviral therapy (HAART) from other studies in which they are coenrolled. Blood and urine collection will occur at study entry and periodically throughout the study. Women may undergo pelvic exams and Pap smears. Portions of blood samples will be stored to evaluate genotypic/phenotypic susceptibility testing. Medical histories, physical exams, and questionnaires will be completed periodically.

Conditions
HIV Infections
Keywords
Treatment Experienced, Treatment Naive, Virus Replication, AIDS-Related Opportunistic Infections, HIV-1, Risk Factors, Incidence, RNA, Viral, Anti-HIV Agents, Viral Load, Lipodystrophy, Nervous System, Cardiovascular System, Neurologic Symptoms
Medical subject headings
HIV Infections, AIDS-Related Opportunistic Infections, Lipodystrophy, Neurologic Manifestations

What is being measured

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

  1. Successive suppressed viral load measures

    Measured: Measured 144 weeks after randomization

  2. Genotypic or phenotypic resistance

    Measured: Measured at baseline and study completion

  3. Complications of HIV disease, including survival, HIV-related opportunistic infections, HIV-related non-opportunistic complications, adverse effects of antiretroviral therapies of grade three or greater

    Measured: Measured throughout

  4. Absolute number and percentage of CD4 and CD8 T cells

    Measured: Measured 144 weeks after randomization

  5. Absolute number and percentage of naive cells, including CD4, CD45RA, and CD62L cells

    Measured: Measured 144 weeks after randomization

  6. Absolute number and percentage of memory cells, including CD4, CD45RO+, and CD45RA- cells

    Measured: Measured 144 weeks after randomization

  7. Levels of immune activation markers, including CD8, CD38, and HLA-DR cells

    Measured: Measured 144 weeks after randomization

Secondary outcomes (9)

  1. HIV-1 latency or replication in tissue or cellular reservoirs

    Measured: Measured at baseline, Week 16, Week 48, and study completion

  2. Syncytium and non-syncytium inducing (SI/NSI) phenotype

    Measured: Measured at baseline, Week 16, Week 48, and study completion

  3. Metabolic and neurologic complications

    Measured: Measured at baseline, Week 16, Week 48, and study completion

  4. Immune responses to antigens such as cytomegalovirus (CMV), Myobacterium avium complex (MAC), Candida, and HIV

    Measured: Measured 144 weeks after randomization

  5. Plasma concentrations of antiretroviral medications other than nucleoside/tide reverse transcriptase inhibitors (NRTIs)

    Measured: Measured at baseline, Week 16, and study completion

  6. Effect of gender, use of hormonal therapies, presence or absence of menopause on short- and long-term virologic suppression, and pap smear abnormalities

    Measured: Measured at baseline, Week 48, and study completion

  7. Quality of life scores

    Measured: Measured at baseline, Week 48, and study completion

  8. Subject-reported patterns of adherence

    Measured: Measured at baseline, Week 48, and study completion

  9. Estimated inpatient, outpatient, and total costs

    Measured: Measured at study completion

Timeline

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

  1. First posted31 Aug 2001 (estimated)
  2. Study startJan 2000
  3. Primary completionNov 2013
  4. Study completionNov 2013

Resources

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
5,982 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00001137
Sponsor's protocol ID
ACTG A5001
Other IDs
1U01AI068636, AACTG A5001
Status last verified
Dec 2013
First submitted
28 Jan 2000
Last updated
6 Dec 2013
Results posted
No

Publications

  • Jain R, Clark NM, Diaz-Linares M, Grim SA. Limitations of current antiretroviral agents and opportunities for development. Curr Pharm Des. 2006;12(9):1065-74. doi: 10.2174/138161206776055813.

    PubMed 16515486

  • Torre D, Speranza F, Martegani R. Impact of highly active antiretroviral therapy on organ-specific manifestations of HIV-1 infection. HIV Med. 2005 Mar;6(2):66-78. doi: 10.1111/j.1468-1293.2005.00268.x.

    PubMed 15807712

  • Siddiqui M, Moore TJ, Long DM, Burkholder GA, Willig A, Wyatt C, Heath S, Muntner P, Overton ET. Risk Factors for Incident Hypertension Within 1 Year of Initiating Antiretroviral Therapy Among People with HIV. AIDS Res Hum Retroviruses. 2022 Sep;38(9):735-742. doi: 10.1089/AID.2021.0213. Epub 2022 Aug 23.

    PubMed 35778856

  • Angelidou K, Hunt PW, Landay AL, Wilson CC, Rodriguez B, Deeks SG, Bosch RJ, Lederman MM. Changes in Inflammation but Not in T-Cell Activation Precede Non-AIDS-Defining Events in a Case-Control Study of Patients on Long-term Antiretroviral Therapy. J Infect Dis. 2018 Jun 20;218(2):239-248. doi: 10.1093/infdis/jix666.

    PubMed 29309629

  • Coban H, Robertson K, Smurzynski M, Krishnan S, Wu K, Bosch RJ, Collier AC, Ellis RJ. Impact of aging on neurocognitive performance in previously antiretroviral-naive HIV-infected individuals on their first suppressive regimen. AIDS. 2017 Jul 17;31(11):1565-1571. doi: 10.1097/QAD.0000000000001523.

    PubMed 28471765

  • Riddler SA, Aga E, Bosch RJ, Bastow B, Bedison M, Vagratian D, Vaida F, Eron JJ, Gandhi RT, Mellors JW; ACTG A5276s Protocol Team. Continued Slow Decay of the Residual Plasma Viremia Level in HIV-1-Infected Adults Receiving Long-term Antiretroviral Therapy. J Infect Dis. 2016 Feb 15;213(4):556-60. doi: 10.1093/infdis/jiv433. Epub 2015 Sep 2.

    PubMed 26333941

  • Lee AJ, Bosch RJ, Evans SR, Wu K, Harrison T, Grant P, Clifford DB. Patterns of peripheral neuropathy in ART-naive patients initiating modern ART regimen. J Neurovirol. 2015 Apr;21(2):210-8. doi: 10.1007/s13365-015-0327-1. Epub 2015 Feb 13.

    PubMed 25678143

  • Besson GJ, Lalama CM, Bosch RJ, Gandhi RT, Bedison MA, Aga E, Riddler SA, McMahon DK, Hong F, Mellors JW. HIV-1 DNA decay dynamics in blood during more than a decade of suppressive antiretroviral therapy. Clin Infect Dis. 2014 Nov 1;59(9):1312-21. doi: 10.1093/cid/ciu585. Epub 2014 Jul 29.

    PubMed 25073894

  • Tenorio AR, Zheng Y, Bosch RJ, Krishnan S, Rodriguez B, Hunt PW, Plants J, Seth A, Wilson CC, Deeks SG, Lederman MM, Landay AL. Soluble markers of inflammation and coagulation but not T-cell activation predict non-AIDS-defining morbid events during suppressive antiretroviral treatment. J Infect Dis. 2014 Oct 15;210(8):1248-59. doi: 10.1093/infdis/jiu254. Epub 2014 May 1.

    PubMed 24795473

  • Cillo AR, Krishnan S, McMahon DK, Mitsuyasu RT, Para MF, Mellors JW. Impact of chemotherapy for HIV-1 related lymphoma on residual viremia and cellular HIV-1 DNA in patients on suppressive antiretroviral therapy. PLoS One. 2014 Mar 17;9(3):e92118. doi: 10.1371/journal.pone.0092118. eCollection 2014.

    PubMed 24638072

  • Lok JJ, Hunt PW, Collier AC, Benson CA, Witt MD, Luque AE, Deeks SG, Bosch RJ. The impact of age on the prognostic capacity of CD8+ T-cell activation during suppressive antiretroviral therapy. AIDS. 2013 Aug 24;27(13):2101-10. doi: 10.1097/QAD.0b013e32836191b1.

    PubMed 24326304

  • Atkinson BE, Krishnan S, Cox G, Hulgan T, Collier AC. Anthropometric differences between HIV-infected individuals prior to antiretroviral treatment and the general population from 1998-2007: the AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT) cohort and NHANES. PLoS One. 2013 Jun 3;8(6):e65306. doi: 10.1371/journal.pone.0065306. Print 2013.

    PubMed 23755215

  • Lok JJ, Bosch RJ, Benson CA, Collier AC, Robbins GK, Shafer RW, Hughes MD; ALLRT team. Long-term increase in CD4+ T-cell counts during combination antiretroviral therapy for HIV-1 infection. AIDS. 2010 Jul 31;24(12):1867-76. doi: 10.1097/QAD.0b013e32833adbcf.

    PubMed 20467286

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 77 sites in 2 countries.

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 5 inclusion and 1 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 6 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States, Puerto Rico. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Successive suppressed viral load measures (time frame: Measured 144 weeks after randomization). The study lists 7 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 NCT00001137, which also lists 13 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 6 Dec 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in