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

This study has been completed.

First Received on November 2, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	Agouron Pharmaceuticals
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002170

Purpose

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.

Condition	Intervention	Phase
Mycobacterium Avium-Intracellulare Infection HIV Infections	Drug: Nelfinavir mesylate	Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS Mycobacterial Infections

Drug Information available for: Nelfinavir Nelfinavir Mesylate

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002170

Locations

United States, California
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 92103
Harbor UCLA Med Ctr
Torrance, California, United States, 90502
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
United States, Massachusetts
Boston VA Med Ctr / 151
Boston, Massachusetts, United States, 02730
United States, Texas
Baylor Univ
Houston, Texas, United States, 77009

Sponsors and Collaborators

Agouron Pharmaceuticals

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00002170 History of Changes
Other Study ID Numbers:	259C, Study 518, AG1343-518
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

AIDS-Related Opportunistic Infections
Placebos
Mycobacterium avium-intracellulare Infection
Acquired Immunodeficiency Syndrome

HIV Protease Inhibitors
Nelfinavir
Anti-Infective Agents
Anti-HIV Agents

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Mycobacterium Infections
Mycobacterium avium-intracellulare Infection
Opportunistic Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Actinomycetales Infections

Gram-Positive Bacterial Infections
Bacterial Infections
Mycobacterium Infections, Atypical
Infection
Parasitic Diseases
Anti-Infective Agents
Nelfinavir
HIV Protease Inhibitors
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on February 12, 2012