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A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium Avium Infection in HIV-Infected Individuals.

NCT00000641 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-11-03

No results posted yet for this study

Summary

To compare the effectiveness and toxicity of two combination drug treatment programs for the treatment of disseminated Mycobacterium avium infection in HIV seropositive patients. \[Per 03/06/92 amendment: to evaluate the efficacy of azithromycin when given in conjunction with either ethambutol or clofazimine as maintenance therapy.\] Disseminated M. avium infection is the most common systemic bacterial infection complicating AIDS in the United States. The prognosis of patients with disseminated M. avium is extremely poor, particularly when it follows other opportunistic infections or is associated with anemia. Test tube studies and clinical data indicate that the best treatment program may include clofazimine, ethambutol, a rifamycin derivative, and ciprofloxacin. Test tube and animal studies indicate that amikacin is a bactericidal (bacteria destroying) drug that works better when used with ciprofloxacin. Its role in treatment programs is a key issue because of toxicity and because it must be administered parenterally (by injection or intravenously).

Conditions

  • Mycobacterium Avium-intracellulare Infection
  • HIV Infections

Interventions

DRUG

Ciprofloxacin hydrochloride

DRUG

Ethambutol hydrochloride

DRUG

Amikacin sulfate

DRUG

Azithromycin

DRUG

Rifampin

DRUG

Clofazimine

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • DM Parenti

  • J Ellner

Study Design

Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Completion
1994-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00000641 on ClinicalTrials.gov