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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 Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD 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 committed 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 health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like 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 for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes 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. Subjects oftentimes recieve the most effective healthcare possible 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. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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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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4. A Study of Zidovudine in HIV-Infected Pregnant Women and Their Children
5. Emtricitabine Given Once A Day with Other Anti-HIV Drugs in Children with HIV
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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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