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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002058
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1990
  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: Primary Purpose: Treatment
Official Title: A Randomized Controlled Prophylactic Study of Clofazimine To Prevent Mycobacterium Avium Complex Infection in HIV Disease

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002058

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

Publications:
ClinicalTrials.gov Identifier: NCT00002058     History of Changes
Other Study ID Numbers: 027A
Study First Received: November 2, 1999
Last Updated: June 23, 2005
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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Infection
Mycobacterium avium-intracellulare Infection
Mycobacterium Infections
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Mycobacterium Infections, Nontuberculous
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Clofazimine
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Leprostatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014