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

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

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Key information

Conditions

Mycobacterium Avium-intracellular Infection Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univ of Arizona / Health Science Ctr, Tucson, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clarithromycin

Drug

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

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

Important dates

Study start: 1992
Primary completion: 1994
Study completion: 1994
First posted: Aug 31, 2001
Registry last updated: Jan 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed