Status:
COMPLETED
Randomized Placebo-Controlled Trial of Atorvastatin in HIV-Positive Patients Not on Antiretroviral Therapy
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 d...
Detailed Description
This protocol is a randomized, double blind, placebo controlled trial designed to study the effects of the lipid lowering statin, atorvastatin on HIV-1 viremia. Untreated HIV-1 infection results in a...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Adults 18 years of age or older.
- Human Immunodeficiency Virus -1 (HIV-1) infection, as documented by a licensed Enzyme-Linked Immunosorbent Assay (ELISA) test kit and confirmed by a Western blot assay at any time point prior to study entry or at study entry (May do after informed consent if no test results are available).
- Off all antiretroviral (ARV) for greater than or equal to three months prior to study entry, no documented evidence of viral resistance, and no evidence of acute HIV infection.
- Willingness to use a method of contraception during the study period.
- Willingness to have blood drawn.
- No known allergy or contraindication to atorvastatin use.
- Ability to understand and willingness to sign the informed consent.
- Willingness to have blood stored for future phenotyping and genotyping.
- Cluster of differentiation 4 (CD4) cell count greater than 350 cells/ml.
- 3 viral loads that average greater than 1000 copies/ml within a 4-week period.
- The viral loads will be done using the branched deoxyribonucleic acid (bDNA) method in the National Institutes of Health (NIH) laboratory and must be within 20% (log10bDNA of each other).
- A fasting total cholesterol lower than 240mg/dl and an Low-density lipoprotein (LDL) cholesterol lower than 130mg/dl.
- Liver function tests (aspartate aminotransferase (AST) or alanine aminotransferase (ALT)) not greater than 1.5 times the upper limit of normal.
- Creatine phosphokinase elevations (CPK) not greater than 3 times the upper limit of normal (ULN) on two sequential determinations and, in the opinion of the investigator, without clear association with exercise.
- Laboratory values:
- Absolute neutrophil count (ANC) greater than or equal to 1000/mm(3).
- Hemoglobin greater than or equal to 11.0 g/dL.
- Platelet count greater than or equal to 100,000/mm(3).
- Creatinine less than or equal to 2 x ULN.
- Serum amylase and lipase less than or equal to 1.25 x ULN.
- Negative serum pregnancy test at randomization.
- EXCLUSION CRITERIA:
- Pregnancy or breast feeding.
- Active drug use or alcohol abuse/dependence, which in the opinion of the investigators, will interfere with the patient's ability to participate in the study.
- Serious illness requiring systemic treatment and/or hospitalization within 30 days of entry.
- Evidence of active opportunistic infections or neoplasms that require chemotherapy during the study period except cutaneous Kaposi Sarcoma.
- Allergy or hypersensitivity to atorvastatin or any of its components.
- History of myositis or rhabdomyolysis with use of any statins.
- History of inflammatory muscle disease such as poly or dermatomyositis.
- Concomitant use of fibric acid derivatives or other lipid lowering agents including patients on statins and Ezetimibe.
- Concomitant use of drugs that have significant interactions with atorvastatin. Please see appendix II for a listing.
- Concomitant use of St.Johns wort.
- Concomitant use of Valproic acid.
- Patients who are on concurrent immunomodulatory agents, including systemic corticosteroids, will be ineligible for 3 months after completion of therapy with the immunomodulating agents. Topical, nasal or inhaled corticosteroids use is not an exclusion criterion.
- Serum LDL cholesterol less than 40 mg/dl.
- Vaccinations within 6 weeks of study entry.
- Vaccinations within 6 weeks of study entry.
Exclusion
Key Trial Info
Start Date :
October 18 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00367458
Start Date
October 18 2006
End Date
June 19 2008
Last Update
February 26 2020
Active Locations (3)
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1
Naval Medical Center, San Diego
San Diego, California, United States, 92134-5000
2
National Naval Medical Center
Bethesda, Maryland, United States, 20889
3
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892