A Study of Viracept in AIDS Patients With Mycobacterium Avium Complex Disease (MAC)

The purpose of this study is to see if it is safe and effective to give Viracept to AIDS patients who are being treated for MAC.

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Key information

Conditions

Mycobacterium Avium-intracellulare Infection AIDS-Related Opportunistic Infections Acquired Immunodeficiency Syndrome Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Genital Diseases Gram-Positive Bacterial Infections HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mycobacterium Infections Mycobacterium Infections, Nontuberculous Opportunistic Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Univ of California / San Diego Treatment Ctr, San Diego, California, 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
New diagnosis of MAC bacteremia and < 7 days of therapy.

Prior Medication:

Allowed:

Patients no more than 7 days of therapy for MAC disease.

Exclusion criteria

Prior Medication:

Excluded:

Prior therapy (or less than 2 weeks) with protease inhibitors other than saquinavir.

Treatment and study plan

nelfinavir mesylate

Drug

Sponsors and collaborators

Lead sponsor

Agouron Pharmaceuticals

Industry

Registry information

Official study title

A Pilot, Phase II, Randomized, Placebo-Controlled Study to Determine the Effects of Viracept on the Clinical Outcome of Disseminated Mycobacterium Avium Complex Disease (MAC) in AIDS Patients Who Are Receiving Standard Acute Treatment for This Opportunistic Infection

Important dates

First posted: Aug 31, 2001
Registry last updated: Jun 24, 2005

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