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

Sponsor
University of California, San Francisco (Other)
Overall Status
Completed
CT.gov ID
NCT00002058
Collaborator
(none)
2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Prophylactic Study of Clofazimine To Prevent Mycobacterium Avium Complex Infection in HIV Disease

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Keith Med Group Los Angeles California United States 90048
    2 San Francisco Gen Hosp San Francisco California United States 941102859

    Sponsors and Collaborators

    • University of California, San Francisco

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00002058
    Other Study ID Numbers:
    • 027A
    First Posted:
    Aug 31, 2001
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Dec 1, 1990

    Study Results

    No Results Posted as of Jun 24, 2005