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NCT01351025 · ClinicalTrials.gov registry record · Phase 2
Atorvastatin on Biomarkers of Inflammation, Coagulopathy, Angiogenesis & T-cells
A Phase 2 study of HIV-1-infection, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- Completed
- Registry status
- Phase 2
- Development phase
- 98
- Enrollment target
- 20
- Study locations
NCT01351025: Completed Phase 2 study of HIV-1-infection, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
NCT01351025 is a Phase 2 study of HIV-1-infection that has completed, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. The registered enrollment target is 98 participants, below the 350-participant average among 71 other HIV-1-infection trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01351025, a Phase 2 study of HIV-1-infection, has completed, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 98 participants
- Enrollment target
- 20
- Study locations
Study Summary
ACTG A5275 was a prospective, double-blind, randomized, placebo-controlled cross-over design pilot study evaluating the effect of atorvastatin on biomarkers of inflammation, coagulopathy, angiogenesis, and T-lymphocyte activation in HIV-1 infected individuals with suppressed HIV-1 RNA on stable protease inhibitor based antiretroviral therapy with fasting LDL cholesterol \< 130 mg/dL. Atorvastatin is a drug approved by the Food and Drug Administration (FDA) for treating high cholesterol. Atorvastatin has also been able to lower the level of inflammation blood tests in certain other diseases but has not been studied for this purpose in people who have HIV. The main goal of this experimental study is to see how taking atorvastatin affects inflammation blood tests in people infected with HIV who do not need to take medicine for high cholesterol. In addition to observing the effects of atorvastatin on the level of inflammation measured in the blood, this study evaluated if atorvastatin is safe for people with HIV who are also taking medication for HIV.
Primary Outcome
IL-6 (Interleukin 6) in log10 pg/mL: Difference between \[change from week 24 to week 44\] and \[change from baseline to week 20\] (i.e. \[week 44 - week 24\] - \[week 20 - baseline\])
Conditions Studied
Interventions
- DRUG atorvastatin
- DRUG placebo for atorvastin
Study Locations (20)
New York
- Cornell CRS (7804) - New York
- NY Univ. HIV/AIDS CRS (401) - New York
- AIDS Care CRS (1101) - Rochester
- University of Rochester Adult HIV Therapeutic Strategies Network CRS (31787) - Rochester
California
- UCLA CARE Center CRS (601) - Los Angeles
- Ucsd, Avrc Crs (701) - San Diego
- Harbor-UCLA Med. Ctr. CRS (603) - Torrance
Massachusetts
- Massachusetts General Hospital ACTG CRS (101) - Boston
- Brigham and Women's Hosp. ACTG CRS (107) - Boston
- Beth Israel Deaconess Med. Ctr., ACTG CRS (103) - Boston
Michigan
- Wayne State Univ. CRS (31478) - Detroit
- Henry Ford Hosp. CRS (31472) - Detroit
New Jersey
- Cooper Univ. Hosp. CRS (31476) - Camden
- New Jersey Medical School-Adult Clinical Research Ctr. CRS (31486) - Newark
Alabama
- 31788 Alabama CRS - Birmingham
Colorado
- University of Colorado Hospital CRS (6101) - Aurora
District of Columbia
- Georgetown University CRS (GU CRS) (1008) - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2011-04-14 |
| Est. Completion | 2014-05 |
| Phase | Phase 2 |
What the finished NCT01351025 record still lists
NCT01351025 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 350-participant average among 71 other HIV-1-infection trials with a reported enrollment target (72% lower).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 2 interventions - of which atorvastatin is the first listed.
NCT01351025 names 20 study sites across 11 states, led by New York, California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01351025 about?
NCT01351025 is a clinical study titled "Atorvastatin on Biomarkers of Inflammation, Coagulopathy, Angiogenesis & T-cells". ACTG A5275 was a prospective, double-blind, randomized, placebo-controlled cross-over design pilot study evaluating the effect of atorvastatin on biomarkers of inflammation, coagulopathy, angiogenesis, and T-lymphocyte activation in HIV-1 infected individuals with suppressed HIV-1 RNA on stable prot...
What is the current status of trial NCT01351025?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 98 participants. The study started on 2011-04-14. Estimated completion is 2014-05.
What conditions does trial NCT01351025 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT01351025?
The interventions under investigation include: atorvastatin (DRUG), placebo for atorvastin (DRUG).
Who is sponsoring clinical trial NCT01351025?
This trial is sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01351025 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01351025's enrollment target sits among peer trials
98 33rd of 71 higher than 39 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
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