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A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium avium Complex (MAC) and Fungal Infections in HIV-Infected Patients Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium avium Complex (MAC) and Fungal Infections in HIV-Infected Patients conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium avium Complex (MAC) and Fungal Infections in HIV-Infected Patients Clinical research trials and A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium avium Complex (MAC) and Fungal Infections in HIV-Infected Patients healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium avium Complex (MAC) and Fungal Infections in HIV-Infected Patients. A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium avium Complex (MAC) and Fungal Infections in HIV-Infected Patients Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium avium Complex (MAC) and Fungal Infections in HIV-Infected Patients clinical trial. Participants typically obtain the most effective healthcare available for their A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium avium Complex (MAC) and Fungal Infections in HIV-Infected Patients condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium avium Complex (MAC) and Fungal Infections in HIV-Infected Patients  A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium avium Complex (MAC) and Fungal Infections in HIV-Infected Patients
A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium avium Complex (MAC) and Fungal Infections in HIV-Infected Patients
For Condition: Mycoses,Mycobacterium avium-intracellulare Infection,HIV Infections
Status: Completed
Sponsor(s): Pfizer ,
Synopsis: PRIMARY: To determine the efficacy of azithromycin and rifabutin alone and in combination for the prevention of disseminated Mycobacterium avium Complex (MAC) infection in HIV-infected patients. To determine the efficacy of daily versus weekly fluconazole for the prevention of deep fungal infections in this patient population. SECONDARY: To determine the incidence of bacterial (including mycobacterial) infections, cryptosporidiosis, and toxoplasmosis in azithromycin versus non-azithromycin containing regimens. To determine the incidence of oropharyngeal and vaginal candidiasis in patients treated with daily versus weekly fluconazole. To compare survival and outcomes of primary endpoints in the treatment arms.
Details: Patients are randomized to receive azithromycin alone, rifabutin alone, or the two drugs in combination for MAC prophylaxis. Patients in each treatment group further receive one of two doses of concomitant fluconazole for deep fungal prophylaxis, unless specifically excluded for fluconazole randomization. Patients are followed for 1 to 2 years.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Efficacy Study
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Preventive therapy with isoniazid for M. tuberculosis. - Maintenance therapy for CMV retinitis. Patients must have: - HIV infection or history of an AIDS-defining condition by CDC criteria. - One documented CD4 count < 100 cells/mm3 within 12 months prior to study entry. - NO active MAC disease, MAC bacteremia, or active mycobacterial infection (tuberculous or nontuberculous). - NO acute opportunistic infection. - Life expectancy of more than 6 months. - Consent of parent or guardian if less than legal age of consent. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: ALL PATIENTS - - Unexplained fevers, elevation in alkaline phosphatase, pancytopenia, abnormal liver function tests, or odynophagia for which the diagnoses of MAC and fungal infections have not been excluded. - Serious hypersensitivity reactions to macrolides or rifampin. - Unable to tolerate oral medications. FOR FLUCONAZOLE RANDOMIZATION - - Serious hypersensitivity reaction to fluconazole. - Active fungal infection (cryptococcosis, histoplasmosis, blastomycosis, aspergillosis, Candida esophagitis, thrush, vaginal candidiasis). - Positive baseline urine cryptococcal culture. Concurrent Medication: Excluded for fluconazole randomization: - Maintenance therapy for deep fungal infections. - Chronic therapy with ketoconazole or fluconazole.
Total Enrollment: 720
Location and Contact Information:
Univ of Texas Southwestern Med Ctr
Dallas, Texas, 75235
United States
Harbor - UCLA Med Ctr
Torrance, California, 90509
United States
UCSD Treatment Ctr / Dept of Medicine and Pediatrics
San Diego, California, 92103
United States
Houston Veterans Administration Med Ctr
Houston, Texas, 77030
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Santa Clara Valley Med Ctr
San Jose, California, 951282699
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
United States
UCI Med Ctr
Orange, California, 92668
United States
Baylor College of Medicine
Houston, Texas, 77005
United States
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Additional Information:
Study ID Numbers: 226A; 066-174
Study Start Date:
Record last reviewed: April 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002122
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2. A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium avium Complex (MAC) and Fungal Infections in HIV-Infected Patients
3. Phase I Study of the Safety, Tolerance, and Pharmacokinetics of FK463 in Immunocompromised Children with Fever and Neutropenia
4. Comparative Study of Micafungin (FK463) Versus Placebo as Prophylactic Antifungal Therapy in the ICU
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A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium avium Complex (MAC) and Fungal Infections in HIV-Infected Patients
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