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

This study has been completed.

Sponsored by: 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

MedlinePlus related topics:   AIDS   

Drug Information available for:   Nelfinavir    Nelfinavir Mesylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Placebo Control, Safety Study
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
  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
Harbor UCLA Med Ctr    
      Torrance, California, United States, 90502
Univ of California / San Diego Treatment Ctr    
      San Diego, California, United States, 92103
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


Study ID Numbers:   259C, Study 518, AG1343-518
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002170
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

Study placed in the following topic categories:
Bacterial Infections
Opportunistic Infections
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
Mycobacterium Infections, Atypical
Immunologic Deficiency Syndromes
Mycobacterium avium-intracellulare Infection
Virus Diseases
Gram-Positive Bacterial Infections
HIV Infections
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
Mycobacterium Infections
Parasitic Diseases
Nelfinavir
Mycobacterium avium complex infection
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
HIV Protease Inhibitors
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Actinomycetales Infections
Pharmacologic Actions
Protease Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on December 03, 2008




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