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NCT00887653 · ClinicalTrials.gov registry record · Phase 3
Changes in Lipids and Safety of Raltegravir in HIV+ Patients With Hyperlipidemia While on Current Standard Therapy
A Phase 3 study of HIV Infections and HIV, sponsored by The Miriam Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT00887653: Completed Phase 3 study of HIV Infections and HIV, sponsored by The Miriam Hospital.
NCT00887653 is a Phase 3 study of HIV Infections and HIV that has completed, run by The Miriam Hospital. The registered enrollment target is 20 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00887653, a Phase 3 study of HIV Infections and HIV, has completed, sponsored by The Miriam Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study Summary
The success of combination antiretroviral therapy heralded a revolution in the treatment of HIV in the mid-1990s. However, severe treatment-associated side effects have been observed including diabetes and increased cholesterol which are linked to premature heart attacks. This effect has been described among many regimens containing protease inhibitors (PIs), as well as non-nucleoside reverse transcriptase inhibitors (NNRTIs). Raltegravir is a new medicine which has been shown to be potent and efficacious in suppression of the HIV. This study hopes to determine if switching from a PI or NNRTI to raltegravir will decrease cholesterol in subjects with high cholesterol and well controlled HIV. In addition, the study aims to confirm that raltegravir is safe and well tolerated. It also seeks to confirm if raltegravir will have similar anti-HIV activity compared with the patient's previous regimen. The study will last 6 months and will involve 20 subjects. HIV-1 infected men and women on PIs or NNRTIs for at least 12 months before study entry with well controlled HIV will be recruited. Hypotheses: 1. Patients with elevated lipid levels while on combination antiretroviral therapy with PIs or NNRTIs will experience an improvement in lipid levels after switching their PI or NNRTI to a raltegravir based regimen. 2. Raltegravir will be safe and well tolerated. 3. Raltegravir will have similar antiretroviral activity compared with the prior regimen. Primary Objective: To demonstrate an improvement in lipid profile (triglycerides or LDL) in subjects switched to raltegravir from PIs or NNRTIs at 2, 3, and 6 months after study entry. Study Design: Subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily. Those who consent, will receive raltegravir provided by the study for 6 months. At entry, the subjects will undergo a complete physical exam and thereafter targeted exams at each visit. Labs will be drawn as part of clinical
Primary Outcome
Assess changes from baseline triglycerides at 3 months
Conditions Studied
Interventions
- DRUG raltegravir
Study Locations (2)
Massachusetts
- Tufts University - Boston
Rhode Island
- Miriam Hospital Immunology Clinic - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2009-05 |
| Est. Completion | 2014-04 |
| Phase | Phase 3 |
What the finished NCT00887653 record still lists
NCT00887653 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (96% lower).
The record links to 4 conditions, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which raltegravir is the first listed.
NCT00887653 reports a single indexed study location in Massachusetts, Rhode Island.
Frequently Asked Questions
What is clinical trial NCT00887653 about?
NCT00887653 is a clinical study titled "Changes in Lipids and Safety of Raltegravir in HIV+ Patients With Hyperlipidemia While on Current Standard Therapy". The success of combination antiretroviral therapy heralded a revolution in the treatment of HIV in the mid-1990s. However, severe treatment-associated side effects have been observed including diabetes and increased cholesterol which are linked to premature heart attacks. This effect has been descri...
What is the current status of trial NCT00887653?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 20 participants. The study started on 2009-05. Estimated completion is 2014-04.
What conditions does trial NCT00887653 study?
This clinical trial studies the following conditions: HIV Infections, HIV, Hyperlipidemia, Hypertriglyceridemia.
What interventions are being tested in trial NCT00887653?
The interventions under investigation include: raltegravir (DRUG).
Who is sponsoring clinical trial NCT00887653?
This trial is sponsored by The Miriam Hospital, which has 136 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00887653 being conducted?
This trial has 2 study locations across Massachusetts, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00887653's enrollment target sits among peer trials
20 487th of 542 higher than 42 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections 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.
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