Completed
Clofazimine Prophylaxis for Mycobacterium Avium Complex Infection in HIV Disease
What is being tested
Clofazimine
Drug
Who is being recruted
Blood-Borne Infections+22
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+15 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Summary
Principal SponsorUniversity of California, San Francisco
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
This study focuses on HIV infected individuals who are at risk of developing Mycobacterium avium complex infection, a serious opportunistic disease. The main goal is to explore if clofazimine, a medication, can prevent this infection. In the absence of effective antiretroviral therapy, preventing life-threatening opportunistic infections is a potential approach for HIV treatment. The study also includes individuals with Asymptomatic and ARC. The importance of this study lies in its potential to find a way to prevent a currently untreatable infection, improving care for HIV patients.
Principal SponsorUniversity of California, San Francisco
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesActinomycetales InfectionsBacterial Infections and MycosesBacterial InfectionsCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsMycobacterium InfectionsMycobacterium Infections, NontuberculousOpportunistic InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsGram-Positive Bacterial InfectionsAcquired Immunodeficiency SyndromeMycobacterium avium-intracellulare InfectionHIV InfectionsAIDS-Related Opportunistic Infections
Criteria
7 inclusion criteria required to participate
All patients must sign informed consent
Allowed concurrent medication: Antipyretics and analgesics as per the treating physician
Allowed concurrent medication: Antiretroviral therapy, or other experimental protocols
Allowed concurrent medication: Pneumocystis prophylaxis
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8 exclusion criteria prevent from participating
Patients with Mycobacterium avium complex (MAC) infection diagnosis at any site (except isolation from stool in asymptomatic patient)
Patients with 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
Patients with hepatic transaminase elevations or total bilirubin values of > 3 times normal
Patients with known hypersensitivity to clofazimine
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Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
San Francisco Gen Hosp
San Francisco, United StatesCompleted2 Study Centers