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Home > "A" Clinical Trials Conditions > A Randomized Controlled Prophylactic Study of Clofazimine To Prevent Mycobacterium Avium Complex Infection in HIV Disease  A Randomized Controlled Prophylactic Study of Clofazimine To Prevent Mycobacterium Avium Complex Infection in HIV Disease
A Randomized Controlled Prophylactic Study of Clofazimine To Prevent Mycobacterium Avium Complex Infection in HIV Disease
For Condition: Mycobacterium avium-intracellulare Infection,HIV Infections
Status: Completed
Sponsor(s): University of California, San Francisco ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Pneumocystis prophylaxis. - Antiretroviral therapy, or other experimental protocols. - Antipyretics and analgesics as per the treating physician. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: - Unexplained fever. - Night sweats. - Unexplained anemia with hemoglobin < 10 g percent or hematocrit less than 30 percent. - Hepatic transaminase elevations or total bilirubin values of > 3 times normal. - Long-term (over 2 weeks) treatment with any drug with known significant anti-Mycobacterium avium complex (MAC) activity including isoniazid, ethambutol, rifampin, raffia, PAS, PZA, amikacin, streptomycin, ethionamide, viomycin, cycloserine, capreomycin, ciprofloxacin, imipenem, rifapentine, gentamicin, or penicillin. Patients with the following are excluded: - Known hypersensitivity to clofazimine. - Mycobacterium avium complex (MAC) infection diagnosis at any site (except isolation from stool in asymptomatic patient). - Any of the following symptoms at the time of study entry: - Unexplained fever. - Night sweats. - Unexplained anemia with hemoglobin < 10 percent or hematocrit less than 30 percent. - Hepatic transaminase elevations or total bilirubin values of > 3 times normal. - Long-term (over 2 weeks) treatment with any drug with known significant anti-MAC activity. Prior Medication: Excluded: - Long-term (over 2 weeks) treatment with any drug with known significant anti-Mycobacterium avium complex (MAC) activity including isoniazid, ethambutol, rifampin, raffia, PAS, PZA, amikacin, streptomycin, ethionamide, viomycin, cycloserine, capreomycin, ciprofloxacin, imipenem, rifapentine, gentamicin, or penicillin. Group 1: - AIDS patients with a first episode of Pneumocystis carinii pneumonia (PCP) within 2 to 4 months prior to study entry. - Group 2: - Patients with T4 counts < 100 cells/mm3, regardless of prior opportunistic infections or malignancies. - Karnofsky = or > 70. - All patients must sign informed consent.
Total Enrollment:
Location and Contact Information:
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Keith Med Group
Los Angeles, California, 90048
United States
Additional Information:
Study ID Numbers: 027A;
Study Start Date:
Record last reviewed: December 1990
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002058
Other Mycobacterium Avium-Intracellulare Infection Studies:
1. A Phase I Trial to Evaluate the Safety and Pharmacokinetics of 1592U89
2. Assessment of Attentional Functioning in Children with HIV-1 Infection
3. Safety and Acceptability of the Anti-Microbe Vaginal Gel, PMPA Gel
4. An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (Viramune) on the Pharmacokinetics of Clarithromycin and Activity of Cytochrome 3A4.
5. Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)phosphonylmethoxyethyl]adenine (bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients
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A Randomized Controlled Prophylactic Study of Clofazimine To Prevent Mycobacterium Avium Complex Infection in HIV Disease
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