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| 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 |
| 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 |
Inclusion Criteria
Patients must have:
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| 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 | |
More Information
| Study ID Numbers: | 259C, Study 518, AG1343-518 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002170 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
AIDS-Related Opportunistic Infections Placebos Mycobacterium avium-intracellulare Infection Acquired Immunodeficiency Syndrome |
HIV Protease Inhibitors Nelfinavir Anti-Infective Agents Anti-HIV Agents |
|
Bacterial Infections Anti-Infective Agents Opportunistic Infections HIV Protease Inhibitors Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Antiviral Agents Mycobacterium Avium Complex Infection Mycobacterium Infections, Atypical Immunologic Deficiency Syndromes Protease Inhibitors |
Mycobacterium avium-intracellulare Infection Virus Diseases Gram-Positive Bacterial Infections Anti-Retroviral Agents HIV Infections AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Mycobacterium Infections Parasitic Diseases Nelfinavir Retroviridae Infections |
|
Bacterial Infections Anti-Infective Agents Opportunistic Infections Communicable Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Gram-Positive Bacterial Infections Anti-Retroviral Agents Therapeutic Uses Parasitic Diseases Nelfinavir Retroviridae Infections RNA Virus Infections |
HIV Protease Inhibitors Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes Actinomycetales Infections Mycobacterium Infections, Atypical Mycobacterium avium-intracellulare Infection Protease Inhibitors Virus Diseases HIV Infections Sexually Transmitted Diseases |
