- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002058
A Randomized Controlled Prophylactic Study of Clofazimine To Prevent Mycobacterium Avium Complex Infection in HIV Disease
June 23, 2005 updated by: University of California, San Francisco
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Los Angeles, California, United States, 90048
- Keith Med Group
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San Francisco, California, United States, 941102859
- San Francisco Gen Hosp
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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 (1988). 1990;3(1):28-31.
- 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. doi: 10.1093/infdis/167.6.1459.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
December 1, 1990
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Mycobacterium Infections, Nontuberculous
- Infections
- Communicable Diseases
- Mycobacterium Infections
- Mycobacterium avium-intracellulare Infection
- Anti-Infective Agents
- Anti-Inflammatory Agents
- Anti-Bacterial Agents
- Leprostatic Agents
- Clofazimine
Other Study ID Numbers
- 027A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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