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A Randomized Controlled Prophylactic Study of Clofazimine To Prevent Mycobacterium Avium Complex Infection in HIV Disease
This study has been completed.
Sponsored by: 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

MedlinePlus related topics: AIDS
Drug Information available for: Clofazimine
U.S. FDA Resources
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
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002058

Locations
United States, California
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
Keith Med Group
Los Angeles, California, United States, 90048
Sponsors and Collaborators
University of California, San Francisco
  More Information

Publications:
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

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections
Mycobacterium avium-intracellulare Infection
Clofazimine
Acquired Immunodeficiency Syndrome

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 12, 2009