A Randomized Controlled Prophylactic Study of Clofazimine To Prevent Mycobacterium Avium Complex Infection in HIV Disease

HIV Infections Clinical Trial

Official title:

A Randomized Controlled Prophylactic Study of Clofazimine To Prevent Mycobacterium Avium Complex Infection in HIV Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002058
• Other study ID #: 027A
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: December 1990
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• Infection
• Mycobacterium Avium-intracellulare Infection
• Mycobacterium Infections

Intervention

Drug:
• Clofazimine

Locations

Country	Name	City	State
United States	Keith Med Group	Los Angeles	California
United States	San Francisco Gen Hosp	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (2)

Abrams DI, Mitchell TF, Child CC, Shiboski SC, Brosgart CL, Mass MM. Clofazimine as prophylaxis for disseminated Mycobacterium avium complex infection in AIDS. J Infect Dis. 1993 Jun;167(6):1459-63. — View Citation

Gustavson LE, Fukuda EK, Rubio FA, Dunton AW. A pilot study of the bioavailability and pharmacokinetics of 2',3'-dideoxycytidine in patients with AIDS or AIDS-related complex. J Acquir Immune Defic Syndr. 1990;3(1):28-31. — View Citation