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| Sponsor: | University of California, San Francisco |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002058 |
Purpose
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 |
|---|---|
|
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 |
Eligibility| 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:
Contacts and Locations| United States, California | |
| San Francisco Gen Hosp | |
| San Francisco, California, United States, 941102859 | |
| Keith Med Group | |
| Los Angeles, California, United States, 90048 | |
More Information
| Study ID Numbers: | 027A |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002058 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
AIDS-Related Opportunistic Infections Mycobacterium avium-intracellulare Infection Clofazimine Acquired Immunodeficiency Syndrome |
|
Anti-Inflammatory Agents Bacterial Infections Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Physiological Effects of Drugs Clofazimine Infection Anti-Bacterial Agents Gram-Positive Bacterial Infections Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics |
Retroviridae Infections RNA Virus Infections Immune System Diseases Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Actinomycetales Infections Mycobacterium Infections, Atypical Pharmacologic Actions Mycobacterium avium-intracellulare Infection Virus Diseases Analgesics, Non-Narcotic HIV Infections Sexually Transmitted Diseases Lentivirus Infections Mycobacterium Infections |