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Completed Phase 1 Interventional Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT00000941

Public ClinicalTrials.gov record NCT00000941. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 3:35 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Evaluation of Potential Pharmacokinetic Interactions Between Protease Inhibitors and Lipid Lowering Agents

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00000941
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
56 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 60 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Not listed
Primary completion
Not listed
Completion
Feb 28, 2002
Last update posted
Oct 28, 2021

Ends 2002

United States locations

U.S. sites
13
U.S. states
11
U.S. cities
13
Facility City State ZIP Site status
Univ of Southern California / LA County USC Med Ctr Los Angeles California 900331079
San Francisco Gen Hosp San Francisco California 941102859
Stanford Univ Med Ctr Stanford California 943055107
Univ of Colorado Health Sciences Ctr Denver Colorado 80262
Univ of Miami School of Medicine Miami Florida 331361013
Univ of Hawaii Honolulu Hawaii 96816
Indiana Univ Hosp Indianapolis Indiana 462025250
Tulane Univ School of Medicine New Orleans Louisiana 70112
Johns Hopkins Hosp Baltimore Maryland 21287
Univ of Minnesota Minneapolis Minnesota 55455
Bellevue Hosp / New York Univ Med Ctr New York New York 10016
Julio Arroyo West Columbia South Carolina 29169
Univ of Washington Seattle Washington 98104

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00000941, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 28, 2021 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00000941 live on ClinicalTrials.gov.

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