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NCT00367458 · ClinicalTrials.gov registry record · Phase 2
Randomized Placebo-Controlled Trial of Atorvastatin in HIV-Positive Patients Not on Antiretroviral Therapy
A Phase 2 study of HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 3
- Study locations
NCT00367458 is a Phase 2 study of HIV that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 24 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (95% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT00367458, a Phase 2 study of HIV, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 3
- Study locations
Study Summary
This study will examine the effects of atorvastatin, a statin (drug that lowers cholesterol) on the human immunodeficiency virus (HIV). If not treated, HIV infection causes an incurable, progressive deficiency in the immune system that leads to death, usually from disease that takes advantage of weakened immunity. Previous studies, however, have suggested that if the amount of cholesterol in infected cells is reduced, multiplication of HIV is also reduced. In this study, researchers will examine the HIV viral loads, that is, amount of the virus in the blood. They will evaluate the composition of the strain of the virus that patients carry (HIV genotype), response of the immune system to the virus, and how genes may determine the way in which the drug may or may not work against the strain of virus. Researchers plan to enroll 22 participants, anticipating a study to last 30 weeks for each participant. Patients ages 18 or older with HIV infection, who are not pregnant or breastfeeding, who do not have a known allergy to atorvastatin use, and who have not had a serious illness or infection that required hospitalization within the 30 days before entering the study may be eligible for this study. They will be assigned to random groups: one that to receive atorvastatin and the other to receive a placebo, which has no effect on cholesterol or ability of the HIV infection to multiply. Patients will remain in their groups and treatments for 8 weeks. At the completion of 8 weeks, no matter the study group, all patients will be required to discontinue all study-related medications for 4 weeks. After that period, the study assignments will be switched, so that those previously taking the placebo will take atorvastatin, and vice versa. The study will proceed for another 8 weeks, followed by a period of stopping study-related medications and patients being observed for 4 weeks. Throughout the study, patients will have regularly scheduled visits at the clinic. At those visits the
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Atorvastatin
Study Locations (3)
Maryland
- National Naval Medical Center - Bethesda
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
California
- Naval Medical Center, San Diego - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2006-10-18 |
| Est. Completion | 2008-06-19 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00367458
The ClinicalTrials.gov registry entry for NCT00367458 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 440-participant average among 303 other HIV trials with a reported enrollment target (95% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00367458 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Maryland, California.
Frequently Asked Questions
What is clinical trial NCT00367458 about?
NCT00367458 is a clinical study titled "Randomized Placebo-Controlled Trial of Atorvastatin in HIV-Positive Patients Not on Antiretroviral Therapy". This study will examine the effects of atorvastatin, a statin (drug that lowers cholesterol) on the human immunodeficiency virus (HIV). If not treated, HIV infection causes an incurable, progressive deficiency in the immune system that leads to death, usually from disease that takes advantage of wea...
What is the current status of trial NCT00367458?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2006-10-18. Estimated completion is 2008-06-19.
What conditions does trial NCT00367458 study?
This clinical trial studies the following conditions: HIV.
What interventions are being tested in trial NCT00367458?
The interventions under investigation include: Placebo (DRUG), Atorvastatin (DRUG).
Who is sponsoring clinical trial NCT00367458?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00367458 being conducted?
This trial has 3 study locations across California, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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