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Sponsored by: |
University of California, San Francisco |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002058 |
This study will examine the effectiveness of clofazimine in the prophylaxis of Mycobacterium avium complex infection in HIV infected individuals who are at risk to develop this untreatable opportunistic disease. In the absence of truly effective antiretroviral therapy, a potential mode of treatment of patients with HIV infection is to prevent the development of the life-threatening opportunistic infections. Current studies demonstrate a possible efficacy of clofazimine in the prophylaxis against Pneumocystis carinii pneumonia (PCP), the most common AIDS-defining opportunistic infection. Future studies will examine the potential for prophylaxis against the other opportunistic infections. This proposal hopes to define the role of prophylactic clofazimine in preventing the currently untreatable Mycobacterium avium complex infection. AMENDED: To include prophylaxis for Asymptomatic and ARC.
Condition | Intervention |
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Mycobacterium Avium-Intracellulare Infection HIV Infections |
Drug: Clofazimine |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Randomized Controlled Prophylactic Study of Clofazimine To Prevent Mycobacterium Avium Complex Infection in HIV Disease |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
Patients with the following are excluded:
Prior Medication:
Excluded:
Group 1:
United States, California | |
San Francisco Gen Hosp | |
San Francisco, California, United States, 941102859 | |
Keith Med Group | |
Los Angeles, California, United States, 90048 |
Study ID Numbers: | 027A |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002058 |
Health Authority: | United States: Food and Drug Administration |
AIDS-Related Opportunistic Infections Mycobacterium avium-intracellulare Infection Clofazimine Acquired Immunodeficiency Syndrome |
Bacterial Infections Opportunistic Infections Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Clofazimine 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 Mycobacterium avium complex infection Retroviridae Infections |
Anti-Inflammatory Agents Communicable Diseases Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Immune System Diseases Physiological Effects of Drugs Infection Actinomycetales Infections Pharmacologic Actions Anti-Bacterial Agents |
Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Lentivirus Infections Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents Leprostatic Agents |