The Safety and Effectiveness of Clarithromycin in the Prevention of Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients

A Prospective, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study of the Safety and Efficacy of Clarithromycin for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients With CD4 Counts <= 100 Cells/mm3

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002336

Enrollment

Unknown

Registered

2001-08-31

Start date

1992-11-30

Completion date

1994-11-30

Last updated

2015-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Mycobacterium Avium-intracellular Infection

Keywords

Mycobacterium avium-intracellular Infection, Acquired Immunodeficiency Syndrome, Clarithromycin

Brief summary

To determine whether clarithromycin is safe and effective in preventing disseminated Mycobacterium avium Complex in HIV-infected patients with CD4 counts \<= 100 cells/mm3.

Interventions

DRUGClarithromycin

Study design

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients must have: * HIV infection. * CD4 count \<= 100 cells/mm3. * No evidence of MAC. * Life expectancy of at least 6 months.

Exclusion criteria

Concurrent Medication: Excluded: * Certain restricted drugs (details not available). Patients with the following prior conditions are excluded: History of allergy or hypersensitivity to macrolides. Active substance abuse or other conditions that would affect study compliance.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026