A Study on Possible Interactions Between Protease Inhibitors (Anti-HIV Drugs) and Drugs Which Lower the Level of Fat in Your Blood

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00000941

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

56

Expected to finish

2002-03-01

Last updated by the study team

2021-10-29

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Univ of Southern California / LA County USC Med Ctr — Los Angeles, California, United States
• San Francisco Gen Hosp — San Francisco, California, United States
• Stanford Univ Med Ctr — Stanford, California, United States
• Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Univ of Hawaii — Honolulu, Hawaii, United States
• Indiana Univ Hosp — Indianapolis, Indiana, United States
• Tulane Univ School of Medicine — New Orleans, Louisiana, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States
• Univ of Minnesota — Minneapolis, Minnesota, United States
• Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States
• Julio Arroyo — West Columbia, South Carolina, United States
• Univ of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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