Study of How Indinavir (an Anti-HIV Drug) and Rifabutin (a Drug Used to Treat MAC, an HIV-Associated Disease) Interact in HIV-Positive and HIV-Negative Adults

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Currently, rifabutin is the only rifamycin that can be administered with indinavir. ACTG 365 is the first formal study of the pharmacokinetics of this dosing combination regimen in HIV seropositive patients. It is hypothesized that staggered administration of rifabutin and indinavir might minimize their pharmacokinetic interaction. If the intestinal tract plays a significant role in the presystemic clearance of rifabutin, the inhibitory activity of indinavir on rifabutin could depend on either luminal concentrations of indinavir, systematic concentrations of indinavir, or both. If luminal c...

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Eligibility criteria

• • Inclusion Criteria
• You may be eligible for this study if you:
• • Are HIV-positive or HIV-negative.
• • Agree to practice abstinence or to use birth control during the study.
• • Exclusion Criteria
• You will not be eligible for this study if you:
• • Have an active opportunistic (HIV-associated) disease or other disease requiring medication within 14 days of study entry.
• • Have a history of illness that might put you at risk if given either of the study drugs.
• • Have had any severe allergies to any substance in the past.
• • Have a history of kidney stones.
• • Have a medical condition, or problems with use of alcohol or drugs, which would keep you from completing the study.
• • Have had tuberculosis and have never been treated for it.
• • Are pregnant or breast-feeding.
• • Are taking certain medications.