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NCT00663234 · ClinicalTrials.gov registry record · Phase 1
IMPAACT P1063: Safety and Effectiveness of Atorvastatin in HIV Infected Children and Adolescents With Hyperlipidemia
A Phase 1 study, sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group.
- Terminated
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT00663234: Clinical Trial Phase 1 study, sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group.
NCT00663234 is a Phase 1 study that was terminated before completion, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00663234, a Phase 1 study, was terminated before completion, sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study 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 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.
Primary Outcome
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.
Interventions
- DRUG Atorvastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2009-08 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
Why NCT00663234 stopped before completion
NCT00663234 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which Atorvastatin is the first listed.
NCT00663234 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00663234 about?
NCT00663234 is a clinical study titled "IMPAACT P1063: Safety and Effectiveness of Atorvastatin in HIV Infected Children and Adolescents With Hyperlipidemia". 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 increa...
What is the current status of trial NCT00663234?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2009-08. Estimated completion is 2014-12.
What interventions are being tested in trial NCT00663234?
The interventions under investigation include: Atorvastatin (DRUG).
Who is sponsoring clinical trial NCT00663234?
This trial is sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00663234's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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