Dual Versus Triple Protease Inhibitor Combinations, Including Ritonavir, in HIV Infected People

Completed · Not applicable

Conditions studied: HIV Infections

In brief

Ritonavir (RTV) is a protease inhibitor (PI) commonly used to increase drug levels of other PIs in HIV drug treatment. The purpose of this study is to compare a combination of drugs which includes RTV and 2 protease inhibitors (PIs) with 2 combinations that include RTV and another PI. This study also will compare the effectiveness, safety, tolerability, and drug levels in the blood of these anti-HIV drug combinations.

Key facts

Study ID

NCT00028366

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

56

Expected to finish

2005-07-01

Last updated by the study team

2021-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• More than 7 days of treatment with LPV and/or more than 7 days of treatment with APV or fosamprenavir
• HIV vaccine within 90 days of study entry
• Experimental drugs within 30 days of study entry
• Cancer chemotherapy within 30 days of study entry
• Drugs that affect the immune system within 30 days of study entry
• Certain drugs within 14 days of study entry. Patients who have used drugs that might damage the kidneys within 7 days of study entry are allowed.
• Midazolam within 7 days of study entry
• Allergic or sensitive to study drugs
• Excessive drug or alcohol use
• Serious illness requiring treatment and/or hospitalization and have not completed therapy, or are not stable on therapy for at least 14 days prior to study entry
• Pregnant or breastfeeding

Where it is running

• USC CRS — Los Angeles, California, United States
• Ucsf Aids Crs — San Francisco, California, United States
• The Ponce de Leon Ctr. CRS — Atlanta, Georgia, United States
• Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
• Indiana Univ. School of Medicine, Wishard Memorial — Indianapolis, Indiana, United States
• Methodist Hosp. of Indiana — Indianapolis, Indiana, United States
• HIV Prevention & Treatment CRS — New York, New York, United States
• Univ. of Cincinnati CRS — Cincinnati, Ohio, United States
• Case CRS — Cleveland, Ohio, United States
• MetroHealth CRS — Cleveland, Ohio, United States
• The Ohio State Univ. AIDS CRS — Columbus, Ohio, United States
• Vanderbilt Therapeutics CRS — Nashville, Tennessee, United States
• University of Washington AIDS CRS — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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