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

NCT00000877 | Completed Phase 1

• 2 other identifiers: ACTG 36511328
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

HIV Infections

Keywords

Rifabutin; Drug Therapy, Combination; HIV Protease Inhibitors; Indinavir; HIV Seronegativity; Anti-HIV Agents

Interventions

Indinavir sulfate DRUG

Rifabutin DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (8)

Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, 900331079, United States

Location

Univ of Southern California / LA County USC Med Cntr

Los Angeles, California, 90033, United States

Location

Univ of Colorado Health Sciences Ctr

Denver, Colorado, 80262, United States

Location

Univ of Miami School of Medicine

Miami, Florida, 331361013, United States

Location

Indiana Univ Hosp

Indianapolis, Indiana, 462025250, United States

Location

Johns Hopkins Hosp

Baltimore, Maryland, 21287, United States

Location

Bellevue Hosp / New York Univ Med Ctr

New York, New York, 10016, United States

Location

Cornell Univ Med Ctr

New York, New York, 10021, United States

Location

Related Publications (2)

• Hamzeh FM, Benson C, Gerber J, Currier J, McCrea J, Deutsch P, Ruan P, Wu H, Lee J, Flexner C; AIDS Clinical Trials Group 365 Study Team. Steady-state pharmacokinetic interaction of modified-dose indinavir and rifabutin. Clin Pharmacol Ther. 2003 Mar;73(3):159-69. doi: 10.1067/mcp.2003.3.

  PMID: 12621381 BACKGROUND

• Hennig S, Svensson EM, Niebecker R, Fourie PB, Weiner MH, Bonora S, Peloquin CA, Gallicano K, Flexner C, Pym A, Vis P, Olliaro PL, McIlleron H, Karlsson MO. Population pharmacokinetic drug-drug interaction pooled analysis of existing data for rifabutin and HIV PIs. J Antimicrob Chemother. 2016 May;71(5):1330-40. doi: 10.1093/jac/dkv470. Epub 2016 Jan 31.

  PMID: 26832753 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Indinavir; Rifabutin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Charles Flexner

  STUDY CHAIR

• Constance Benson

  STUDY CHAIR

• Judith Currier

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: October 1, 2000
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

US (8)