HIV InfectionsPhase 1/2NCT00663234
IMPAACT P1063: Safety and Effectiveness of Atorvastatin in HIV Infected Children and Adolescents With Hyperlipidemia
A Phase 1/2 study testing Atorvastatin in people with HIV Infections and Hyperlipidemia, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 11 sites in United States.
Trial summary
Treatment of HIV with combination antiretroviral regimens frequently results in the suppression of HIV viral load, significant immune recovery, and delayed disease progression. However, treatment with these regimens, particularly protease inhibitors (PIs), has been associated with significant increases in cholesterol… Read more about this study
- Who is it for?
- Ages 10 to 23 years
- Conditions the study is for
- HIV Infections, Hyperlipidemia
- What is being tested?
- Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 11 sitesUnited States
- Study dates
- Aug 2009to Dec 2014
- Phase
- Phase 1/2
- 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 10 to 23 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- A diagnosis of HIV-1 infection
- CD4 % of at least 15 at screening
- HIV-1 viral load of less than 10,000 copies/ml at screening
- On a stable antiretroviral therapy regimen for at least 6 months
- Tanner stage of 2 or higher
- At least two LDL-C measurements of 130 mg/dL or higher over the 6 months prior to screening and after documented attempts at modifying diet and other risk factors. More information on this criterion can be found in the protocol.
Show all 9Show fewer
- Able to fast overnight for 8 hours
- Negative pregnancy test at screening
- Agree to use two appropriate forms of contraception (female participants). More information on this criterion can be found in the protocol.
Who cannot join
- Certain abnormal laboratory values
- Any laboratory or unresolved clinical toxicity of Grade 3 or higher
- Unlikely to remain on current antiretroviral therapy for at least six months after study entry
- Use of statin, fibrate, or niacin within 3 months prior to study entry
- Evidence of chronic ongoing myositis or history of myopathy or neuromuscular disorder
- Symptomatic peripheral neuropathy within 6 months prior to study entry
Show all 14Show fewer
- Pharmacologic treatment for depression or other mental disorder excluding Attention Deficit Disorder within 30 days prior to study entry
- Presence of an active CDC Stage C opportunistic infection or serious bacterial infection requiring therapy within 2 weeks prior to screening.
- Chemotherapy for malignancy within 3 months prior to study entry
- Hepatitis B Surface Antigen positive
- Hepatitis C viremia
- Insulin-dependent diabetes mellitus
- Required treatment with an agent contraindicated with either atorvastatin or PIs. More information on this criterion can be found in the protocol.
- Pregnant or breastfeeding
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Univ. of Colorado Denver NICHD CRS (5052)
Aurora, Colorado, 80045
Boston Medical Center Ped. HIV Program NICHD CRS (5011)
Boston, Massachusetts, 02118
Chicago Children's CRS (4001)
Chicago, Illinois, 60614
Texas Children's Hosp. CRS (3801)
Houston, Texas, 77030
St. Jude/UTHSC CRS (6501)
Memphis, Tennessee, 38105
Univ. of Miami Ped. Perinatal HIV/AIDS CRS (4201)
Miami, Florida, 33136
Tulane University (5095)
New Orleans, Louisiana, 70112
New York University NY (5012)
New York, New York, 10016
Metropolitan Hospital (5003)
New York, New York, 10029
University of South Florida Tampa (5018)
Tampa, Florida, 33620
Bronx-Lebanon Hospital IMPAACT CRS (6901)
The Bronx, New York, 10457
About this study
Official title: Phase I/II Safety and Efficacy Investigation of Atorvastatin for Treatment of PI-Associated Increased LDL Cholesterol in HIV-Infected Children and Adolescents
Treatment of HIV with combination antiretroviral regimens frequently results in the suppression of HIV viral load, significant immune recovery, and delayed disease progression. However, treatment with these regimens, particularly protease inhibitors (PIs), has been associated with significant increases in cholesterol and triglycerides in HIV-infected adults and children. The purpose of this study was to evaluate the safety and effectiveness of escalating doses of atorvastatin, a FDA-approved drug which lowers cholesterol and triglyceride levels, in HIV-infected children receiving stable antiretroviral regimens.
Read the detailed description
Antiretroviral regimens, particularly those containing PIs, often cause hyperlipidemia, which is an increase in the amount of fat (such as cholesterol and triglycerides) in the blood. These increases can lead to heart disease and pancreatitis. Although the mechanism by which PIs cause hyperlipidemia is not clearly understood, there are medications to combat this side effect. The primary purpose of this study was to evaluate the safety and effectiveness of escalating doses of atorvastatin, based on low-density lipoprotein cholesterol (LDL-C) levels, in HIV-infected children receiving stable antiretroviral therapy.
Participants were assigned to one of two groups based on age (10 to 14 years or 15 to 23 years) and were treated for a maximum of 48 weeks. The first six participants enrolled in the study were in the 15 to 23 year old age group. Once safety data through week 8 on these 6 participants was analyzed, the remaining participants were enrolled. All participants received atorvastatin in combination with a stable antiretroviral regimen. Each participant was followed independently according to a dose escalation algorithm for atorvastatin. Participants began dosing at 10 mg daily. If efficacy criteria were not met, dosing increased to 20 mg daily at week 8. Since dose escalations were done within subject, safety and efficacy rates were presented for the dose-escalation strategy overall and not for individual doses. Atorvastatin was provided by the study, but antiretrovirals were not.
Study visits occurred at study entry and weeks 4, 8, 12, 24, 36, and 48. Safety labs were collected at all study visits. Blood collection for lipid measurements occurred at weeks 4, 12, 24 and 48.
- Conditions
- HIV Infections, Hyperlipidemia
- Being tested
- Atorvastatin
- Keywords
- Treatment Experienced
- Medical subject headings
- HIV Infections, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Lipitor
10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria.
| Study group | Role | What they receive |
|---|---|---|
| Age 10 to 14 | Experimental | Participants ages 10 to 14 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen Receives: Drug: Atorvastatin |
| Age 15 to 23 | Experimental | Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE)
AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the core study team. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.
Measured: Study entry to weeks 12, 24, and 48
Percentage of Participants Experiencing at Least One Adverse Event (AE)
AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.
Measured: Study entry to weeks 12, 24, and 48
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Intention to Treat)
Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.
Measured: Study entry and weeks 4, 12, 24, and 48
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Data Available)
Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.
Measured: Study entry and weeks 4, 12, 24, and 48
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Per Protocol)
Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.
Measured: Study entry and weeks 4, 12, 24, and 48
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria and Did Not Experience a Primary Safety Endpoint Attributable to Study Drug
Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.
Measured: Study entry and weeks 4, 12, 24, and 48
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by Age Group
Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.
Measured: Study entry and weeks 4, 12, 24, and 48
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by NNRTI Treatment
Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.
Measured: Study entry and weeks 4, 12, 24, and 48
Percent Change in LDL Cholesterol (LDL-C) From Study Entry
Measured: Study entry and weeks 4, 12, 24, and 48
Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) by Age Group
AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the core study team. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.
Measured: Study entry to weeks 12, 24, and 48
Percentage of Participants Experiencing at Least One Adverse Event (AE) by Age Group
AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.
Measured: Study entry to weeks 12, 24, and 48
Secondary outcomes (8)
Percent Change in Fasting Total Cholesterol (TC) From Study Entry
Measured: Study entry and weeks 4, 12, 24, and 48
Percent Change in Triglycerides (TG) From Study Entry
Measured: Study entry and weeks 4, 12, 24, and 48
Percent Change in HDL-cholesterol (HDL-C) From Study Entry
Measured: Study entry and weeks 4, 12, 24, and 48
Percent Change in Apolipoprotein A1 (Apo A-1) From Study Entry
Measured: Study entry and weeks 12, 24, and 48
Percent Change in Apolipoprotein B (Apo B) From Study Entry
Measured: Study entry and weeks 12, 24, and 48
Percent Change in High-sensitivity CRP (Hs-CRP) From Study Entry
Measured: Study entry and weeks 12, 24, and 48
Percent Change in Interleukin 6 (IL-6) From Study Entry
Measured: Study entry and weeks 12, 24, and 48
Percentage of Participants With Undetectable Plasma HIV-1 RNA
Undetectable is defined as plasma HIV-1 RNA below the lower limit of quantification of the assay used.
Measured: Study entry and weeks 12, 24, and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startAug 2009
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: The study was prematurely discontinued due to administrative reasons.
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 (4)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- Sponsor type
- Research network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Ann Melvin, MD, Study chair, Seattle Children's HospitalMarilyn Crain, MD, MPH, Study chair, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663234
- Sponsor's protocol ID
- IMPAACT P1063
- Other IDs
- U01AI068632, 10167
- Status last verified
- Mar 2016
- First submitted
- 21 Apr 2008
- Last updated
- 6 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kamin D, Hadigan C. Hyperlipidemia in children with HIV infection: an emerging problem. Expert Rev Cardiovasc Ther. 2003 May;1(1):143-50. doi: 10.1586/14779072.1.1.143.
PubMed 15030304Penzak SR, Chuck SK. Management of protease inhibitor-associated hyperlipidemia. Am J Cardiovasc Drugs. 2002;2(2):91-106. doi: 10.2165/00129784-200202020-00003.
PubMed 14727985Solorzano Santos F, Gochicoa Rangel LG, Palacios Saucedo G, Vazquez Rosales G, Miranda Novales MG. Hypertriglyceridemia and hypercholesterolemia in human immunodeficiency virus-1-infected children treated with protease inhibitors. Arch Med Res. 2006 Jan;37(1):129-32. doi: 10.1016/j.arcmed.2005.05.013.
PubMed 16314198The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009)
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Safety and Efficacy Investigation of Atorvastatin for Treatment of PI-Associated Increased LDL Cholesterol in HIV-Infected Children and Adolescents
- ClinicalTrials.gov ID
- NCT00663234
- Acronym / sponsor ID
- IMPAACT P1063
- Conditions
- HIV Infections, Hyperlipidemia
- Keywords
- Treatment Experienced
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was prematurely discontinued due to administrative reasons.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials GroupResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Aug 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Posted 6 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatment of HIV with combination antiretroviral regimens frequently results in the suppression of HIV viral load, significant immune recovery, and delayed disease progression. However, treatment with these regimens, particularly protease inhibitors (PIs), has been associated with significant increases in cholesterol and triglycerides in HIV-infected adults and children. The purpose of this study was to evaluate the safety and effectiveness of escalating doses of atorvastatin, a FDA-approved drug which lowers cholesterol and triglyceride levels, in HIV-infected children receiving stable antiretroviral regimens.
Detailed description
Antiretroviral regimens, particularly those containing PIs, often cause hyperlipidemia, which is an increase in the amount of fat (such as cholesterol and triglycerides) in the blood. These increases can lead to heart disease and pancreatitis. Although the mechanism by which PIs cause hyperlipidemia is not clearly understood, there are medications to combat this side effect. The primary purpose of this study was to evaluate the safety and effectiveness of escalating doses of atorvastatin, based on low-density lipoprotein cholesterol (LDL-C) levels, in HIV-infected children receiving stable antiretroviral therapy.
Participants were assigned to one of two groups based on age (10 to 14 years or 15 to 23 years) and were treated for a maximum of 48 weeks. The first six participants enrolled in the study were in the 15 to 23 year old age group. Once safety data through week 8 on these 6 participants was analyzed, the remaining participants were enrolled. All participants received atorvastatin in combination with a stable antiretroviral regimen. Each participant was followed independently according to a dose escalation algorithm for atorvastatin. Participants began dosing at 10 mg daily. If efficacy criteria were not met, dosing increased to 20 mg daily at week 8. Since dose escalations were done within subject, safety and efficacy rates were presented for the dose-escalation strategy overall and not for individual doses. Atorvastatin was provided by the study, but antiretrovirals were not.
Study visits occurred at study entry and weeks 4, 8, 12, 24, 36, and 48. Safety labs were collected at all study visits. Blood collection for lipid measurements occurred at weeks 4, 12, 24 and 48.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Age 10 to 14 | Experimental | Drug: AtorvastatinParticipants ages 10 to 14 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen |
| Age 15 to 23 | Experimental | Drug: AtorvastatinParticipants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen |
Who may qualify
- Ages
- 10 to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- A diagnosis of HIV-1 infection
- CD4 % of at least 15 at screening
- HIV-1 viral load of less than 10,000 copies/ml at screening
- On a stable antiretroviral therapy regimen for at least 6 months
- Tanner stage of 2 or higher
Key exclusion criteria (14 listed)
- Certain abnormal laboratory values
- Any laboratory or unresolved clinical toxicity of Grade 3 or higher
- Unlikely to remain on current antiretroviral therapy for at least six months after study entry
- Use of statin, fibrate, or niacin within 3 months prior to study entry
- Evidence of chronic ongoing myositis or history of myopathy or neuromuscular disorder
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 |
|---|---|---|
| AtorvastatinAlso: Lipitor10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria. | Drug | Age 10 to 14, Age 15 to 23 |
Primary outcome
Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE)
Time frame: Study entry to weeks 12, 24, and 48
AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the core study team. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.
Percentage of Participants Experiencing at Least One Adverse Event (AE)
Time frame: Study entry to weeks 12, 24, and 48
AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Intention to Treat)
Time frame: Study entry and weeks 4, 12, 24, and 48
Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Data Available)
Time frame: Study entry and weeks 4, 12, 24, and 48
Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Per Protocol)
Time frame: Study entry and weeks 4, 12, 24, and 48
Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria and Did Not Experience a Primary Safety Endpoint Attributable to Study Drug
Time frame: Study entry and weeks 4, 12, 24, and 48
Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by Age Group
Time frame: Study entry and weeks 4, 12, 24, and 48
Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.
Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by NNRTI Treatment
Time frame: Study entry and weeks 4, 12, 24, and 48
Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week.
Percent Change in LDL Cholesterol (LDL-C) From Study Entry
Time frame: Study entry and weeks 4, 12, 24, and 48
Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) by Age Group
Time frame: Study entry to weeks 12, 24, and 48
AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the core study team. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.
Percentage of Participants Experiencing at Least One Adverse Event (AE) by Age Group
Time frame: Study entry to weeks 12, 24, and 48
AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher.
8 secondary outcomes
Percent Change in Fasting Total Cholesterol (TC) From Study Entry
Time frame: Study entry and weeks 4, 12, 24, and 48
Percent Change in Triglycerides (TG) From Study Entry
Time frame: Study entry and weeks 4, 12, 24, and 48
Percent Change in HDL-cholesterol (HDL-C) From Study Entry
Time frame: Study entry and weeks 4, 12, 24, and 48
Percent Change in Apolipoprotein A1 (Apo A-1) From Study Entry
Time frame: Study entry and weeks 12, 24, and 48
Percent Change in Apolipoprotein B (Apo B) From Study Entry
Time frame: Study entry and weeks 12, 24, and 48
Percent Change in High-sensitivity CRP (Hs-CRP) From Study Entry
Time frame: Study entry and weeks 12, 24, and 48
Percent Change in Interleukin 6 (IL-6) From Study Entry
Time frame: Study entry and weeks 12, 24, and 48
Percentage of Participants With Undetectable Plasma HIV-1 RNA
Time frame: Study entry and weeks 12, 24, and 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15030304Kamin D, Hadigan C. Hyperlipidemia in children with HIV infection: an emerging problem. Expert Rev Cardiovasc Ther. 2003 May;1(1):143-50. doi: 10.1586/14779072.1.1.143.
- Background: PubMed 14727985Penzak SR, Chuck SK. Management of protease inhibitor-associated hyperlipidemia. Am J Cardiovasc Drugs. 2002;2(2):91-106. doi: 10.2165/00129784-200202020-00003.
- Background: PubMed 16314198Solorzano Santos F, Gochicoa Rangel LG, Palacios Saucedo G, Vazquez Rosales G, Miranda Novales MG. Hypertriglyceridemia and hypercholesterolemia in human immunodeficiency virus-1-infected children treated with protease inhibitors. Arch Med Res. 2006 Jan;37(1):129-32. doi: 10.1016/j.arcmed.2005.05.013.
- BackgroundThe Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009)
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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.
Ann Melvin, MD study chair
Seattle Children's Hospital
Marilyn Crain, MD, MPH study chair
University of Alabama at Birmingham
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Atorvastatin in people with HIV Infections and Hyperlipidemia, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 11 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 9 inclusion and 14 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: stopped early, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 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?
Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) (time frame: Study entry to weeks 12, 24, and 48). The study lists 11 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 NCT00663234, which also lists 4 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 Apr 2016.