Search / Trial NCT00002058

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

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Aug 30, 2001

Trial Information

Current as of November 03, 2024

Completed

Keywords

Aids Related Opportunistic Infections Mycobacterium Avium Intracellulare Infection Clofazimine Acquired Immunodeficiency Syndrome

ClinConnect Summary

No description provided

Gender

ALL

Eligibility 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.

About University Of California, San Francisco

The University of California, San Francisco (UCSF) is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a focus on translating scientific discoveries into effective therapies, UCSF collaborates with a diverse array of stakeholders, including healthcare professionals, industry partners, and patient communities. The university's research programs emphasize interdisciplinary approaches and leverage cutting-edge technology to address complex medical challenges. As a sponsor of clinical trials, UCSF is dedicated to maintaining the highest standards of ethical conduct and scientific rigor, ensuring the safety and well-being of participants while contributing to the broader medical knowledge base.

Locations

San Francisco, California, United States

Los Angeles, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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