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Atorvastatin on Biomarkers of Inflammation, Coagulopathy, Angiogenesis & T-cells
NCT01351025 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01351025
The ClinicalTrials.gov registry entry for NCT01351025 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 15 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01351025 reports 20 study locations spanning 11 distinct geographic areas — top geographies include New York, California, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01351025?
The interventions under investigation include: atorvastatin (DRUG), placebo for atorvastin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01351025?
This trial is sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 15 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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