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

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Fosamprenavir; HIV Protease Inhibitors; Lopinavir; Protease Inhibitors; Reverse Transcriptase Inhibitors; Ritonavir; Tenofovir

Criteria

Note: Accrual into A5143 and A5147S has been discontinued. The study originally planned to enroll 216 participants, but only 56 participants were enrolled at the time of early termination of enrollment because of interim review results.

Inclusion Criteria for Step 1

• HIV infected

• Past anti-HIV therapy consisting of at least 1 PI-containing regimen or detectable viral load, and at least 1 year total anti-HIV therapy experience

• Viral load of more than 5000 copies/ml within 60 days prior to screening while on a stable anti-HIV therapy for at least 12 weeks

• Agree to use acceptable forms of contraception

Exclusion Criteria

• 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