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NCT00656175 · ClinicalTrials.gov registry record · Phase 2
Raltegravir Therapy for Women With HIV and Fat Accumulation
A Phase 2 study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
NCT00656175: Completed Phase 2 study, sponsored by University of California, Los Angeles.
NCT00656175 is a Phase 2 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 39 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00656175, a Phase 2 study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
Study Summary
Ritonavir-boosted protease inhibitor (PI) regimens have become a backbone for treatment of people with HIV. However, adverse drug effects, particularly lipodystrophy/lipoatrophy are closely associated with these regimens. Therefore, there is a need for a drug with comparable effectiveness to the ritonavir boosted PIs without the side effects of dyslipidemia, which has been associated with elevated cholesterol and cardiovascular disease Raltegravir is an HIV integrase inhibitor in phase III clinical development. To date there are no approved drugs that target the same stage of the HIV-1 lifecycle. However, data from studies indicate that raltegravir is generally safe and well tolerated and has strong antiretroviral activity when used in combination with licensed antiretroviral medications. This study aims to demonstrate that patients substituting raltegravir for a PI or NNRTI based antiretroviral regimen will be associated with a 10% reduction in body fat over 24 weeks. The study will consist of a total of 10 subject visits over a period of 48 weeks. Approximately 40 female patients will participate in this study (approximately 10 at UCLA).
Primary Outcome
Adipose tissue volumes were measured via single slice L4-L5 CT scan, and volumes were calculated using cm\^2, not cm\^3, as is standard protocol at the Tufts University Body Composition Reading Center. The authors acknowledge that cm\^2 uses area as a surrogate for volume, but this protocol is well-accepted in our field.
Interventions
- DRUG raltegravir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2008-09 |
| Est. Completion | 2011-12 |
| Phase | Phase 2 |
What the finished NCT00656175 record still lists
NCT00656175 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 1 intervention - of which raltegravir is the first listed.
NCT00656175 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00656175 about?
NCT00656175 is a clinical study titled "Raltegravir Therapy for Women With HIV and Fat Accumulation". Ritonavir-boosted protease inhibitor (PI) regimens have become a backbone for treatment of people with HIV. However, adverse drug effects, particularly lipodystrophy/lipoatrophy are closely associated with these regimens. Therefore, there is a need for a drug with comparable effectiveness to the rit...
What is the current status of trial NCT00656175?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2008-09. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00656175?
The interventions under investigation include: raltegravir (DRUG).
Who is sponsoring clinical trial NCT00656175?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00656175's enrollment target sits among peer trials
39 1459th of 2000 higher than 534 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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