A Study of Viracept in AIDS Patients With Mycobacterium Avium Complex Disease (MAC)
This study has been completed.
Sponsor:
Agouron Pharmaceuticals
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002170
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: May 1999
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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: | 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:
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 May 23, 2013