Pharmacokinetic interactions between protease inhibitors and statins in HIV seronegative volunteers: ACTG Study A5047.
Carl J Fichtenbaum, John G Gerber, Susan L Rosenkranz...
https://pubmed.ncbi.nlm.nih.gov/11873000Completed
Phase 1
Age: 18Years - 60Years
All Genders
Healthy Volunteers
ID00000941
Evaluation of Potential Pharmacokinetic Interactions Between Protease Inhibitors and Lipid Lowering Agents
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-29
56
Participants Needed
13
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to find out whether taking protease inhibitors (anti-HIV drugs) together with lipid-lowering drugs (drugs which lower the amount of fat in the blood) has an effect on the level of drugs found in the blood compared to when these drugs are taken separately. The three protease inhibitors given in this study are ritonavir, saquinavir, and nelfinavir. The lipid-lowering drugs given are pravastatin, simvastatin, and atorvastatin. Anti-HIV drug therapy using protease inhibitors has become very common treatment for HIV-positive patients. Recently, however, serious side effects involving how the body uses fat have been reported in people taking protease inhibitors. Examples of these side effects are redistribution of body fat and development of diabetes. People taking protease inhibitors have been found to have higher levels of fat in their blood than is normal, which can cause heart problems. It is hoped that giving lipid-lowering drugs can help prevent serious heart problems. First, however, it is important to see what happens when protease inhibitors and lipid-lowering drugs are given together.
CONDITIONS
Official Title
A Study on Possible Interactions Between Protease Inhibitors (Anti-HIV Drugs) and Drugs Which Lower the Level of Fat in Your Blood
Who Can Participate
Age: 18Years - 60Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
You may be eligible for this study if you:
- Are HIV-negative.
- Are between the ages of 18 and 60.
- Agree to use a barrier method of birth control (e.g., a condom) during the study.
Exclusion Criteria
You will not be eligible for this study if you:
- Have a history of a chronic illness such as high blood pressure, heart disease, arthritis, or diabetes.
- Are pregnant or breast-feeding.
- Are taking certain medications.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 13 locations
1
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
Status Unknown
2
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
Status Unknown
3
Stanford Univ Med Ctr
Stanford, California, United States, 943055107
Status Unknown
4
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
Status Unknown
5
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
Status Unknown
6
Univ of Hawaii
Honolulu, Hawaii, United States, 96816
Status Unknown
7
Indiana Univ Hosp
Indianapolis, Indiana, United States, 462025250
Status Unknown
8
Tulane Univ School of Medicine
New Orleans, Louisiana, United States, 70112
Status Unknown
9
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
Status Unknown
10
Univ of Minnesota
Minneapolis, Minnesota, United States, 55455
Status Unknown
11
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Status Unknown
12
Julio Arroyo
West Columbia, South Carolina, United States, 29169
Status Unknown
13
Univ of Washington
Seattle, Washington, United States, 98104
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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Published Research Related To This Trial
Pharmacokinetic interactions between protease inhibitors and statins in HIV seronegative volunteers: ACTG Study A5047, by Fichtenbaum et al.
Christine Wanke
https://pubmed.ncbi.nlm.nih.gov/15080191