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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002170
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  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 2

Study Type: Interventional
Study Design: 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:


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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00002170     History of Changes
Other Study ID Numbers: 259C
Study 518
AG1343-518
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: May 1999

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:
Infection
Communicable Diseases
HIV Infections
Mycobacterium Infections
Opportunistic Infections
Mycobacterium avium-intracellulare Infection
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Parasitic Diseases
Mycobacterium Infections, Nontuberculous
Nelfinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents