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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

The purpose of this study is to evaluate the safety of giving indinavir and rifabutin at the same time (simultaneously) vs 4 hours apart (staggered) to HIV-positive and HIV-negative adults. It is important to determine which medications for HIV-associated diseases, such as Mycobacterium avium complex (MAC) disease, can be given safely and effectively with anti-HIV drugs. Indinavir and rifabutin have been given simultaneously in the past with good results. This study seeks to examine if staggering the doses will make the 2 drugs more effective. HIV-negative volunteers are used in this study to examine the effect of rifabutin on indinavir and the effect of staggered rifabutin doses. The effect of rifabutin on the drug activity of indinavir is evaluated in HIV-positive patients.

Key facts

Study ID

NCT00000877

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

31

Expected to finish

2000-10-01

Last updated by the study team

2021-10-29

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Univ of Southern California / LA County USC Med Ctr — Los Angeles, California, United States
• Univ of Southern California / LA County USC Med Cntr — Los Angeles, California, United States
• Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Indiana Univ Hosp — Indianapolis, Indiana, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States
• Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States
• Cornell Univ Med Ctr — New York, New York, United States

Full record on ClinicalTrials.gov

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