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Completed Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT00000877

Public ClinicalTrials.gov record NCT00000877. 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 5, 2026, 4:05 PM EDT

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

Official title

Steady-State Pharmacokinetic Interaction Study of Indinavir and Rifabutin

Brief summary

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

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.

Study identification

NCT ID
NCT00000877
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
31 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 60 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

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
Sep 30, 2000
Last update posted
Oct 28, 2021

Ends 2000

United States locations

U.S. sites
8
U.S. states
6
U.S. cities
6
Facility City State ZIP Site status
Univ of Southern California / LA County USC Med Ctr Los Angeles California 900331079
Univ of Southern California / LA County USC Med Cntr Los Angeles California 90033
Univ of Colorado Health Sciences Ctr Denver Colorado 80262
Univ of Miami School of Medicine Miami Florida 331361013
Indiana Univ Hosp Indianapolis Indiana 462025250
Johns Hopkins Hosp Baltimore Maryland 21287
Bellevue Hosp / New York Univ Med Ctr New York New York 10016
Cornell Univ Med Ctr New York New York 10021

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 NCT00000877, 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 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00000877 live on ClinicalTrials.gov.

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