Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)
NCT ID: NCT00000676
Last Updated: 2021-11-02
Study Results
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Basic Information
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COMPLETED
PHASE3
500 participants
INTERVENTIONAL
1993-11-30
Brief Summary
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Serious fungal infections are significant complicating and life-threatening occurrences in patients with advanced HIV infection. Oropharyngeal candidiasis is found in almost all such patients, and causes pain, difficulty in swallowing, and loss of appetite. Similarly, esophageal candidiasis causes illness in the population. Cryptococcosis, endemic mycoses, and coccidioidomycosis also cause significant illness and death in AIDS patients. Once established, fungal infections in AIDS patients generally require continuous suppressive therapy because attempts at curing these infections are usually unsuccessful. Fluconazole has a number of characteristics that would make it a logical candidate to examine as a prophylactic agent in patients with advanced HIV infection. Animal studies have shown it to be prophylactic in models of candidiasis, cryptococcosis, histoplasmosis, and coccidioidomycosis. Initial experience in patients with active cryptococcal meningitis appears favorable, and studies of oropharyngeal candidiasis show it to be effective.
Detailed Description
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AMENDED: 11/01/90 Sufficient numbers of patients will be enrolled from all centers starting at week 8 of participation in the parent study to achieve a total of 240 evaluable patients who will remain in the nested study for a maximum duration of 45 months. Enrollment will continue until all eligible and interested 081 patients are enrolled. Fungal prophylaxis will begin at the time of enrollment into the nested study and will continue until an efficacy or safety end point is reached, until withdrawal from the nested study, or until death.
Original design: Patients included are those already enrolled in ACTG 081. Patients are enrolled from all centers at either week 8, 12, 16, 20, 24, 28, or 32 of participation in the parent study. They are randomized to receive either oral fluconazole or clotrimazole troches. Prophylaxis continues until a serious fungal infection develops, the end of the parent study is reached (which is expected to be December 1991), the patient withdraws from either the nested or parent study, or the patient dies. Clinical examination is performed at 2 weeks and then monthly (or more if clinically indicated) for the duration of antifungal prophylaxis; the schedule of evaluation is the same as for the parent study. There is a 1-month postprophylaxis follow-up after discontinuation of prophylaxis for any reason.
Conditions
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Keywords
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Study Design
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PREVENTION
Interventions
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Clotrimazole
Fluconazole
Eligibility Criteria
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Inclusion Criteria
Required:
* Zidovudine (AZT).
* Antipneumocystis prophylaxis.
Allowed:
* Topical suppressive antifungal agents.
Eligibility requirements are:
* Participation in NIAID ACTG 081.
* No history of systemic fungal infection, including esophageal or systemic candidiasis, cryptococcosis, histoplasmosis, coccidioidomycosis, blastomycosis, sporotrichosis, or aspergillosis.
* Willingness to sign an informed consent.
* Transaminases \< 5 x upper limit of normal.
* Noncompliance will not be a reason for withdrawal of a patient from the study, unless patient refuses further treatment.
Allowed:
* A history of oropharyngeal, vaginal or cutaneous candidiasis.
* Dermatophyte infections (i.e., tinea pedis) at entry but not active candida infection. Sites of suspected dermatophyte involvement other than the feet should have candida excluded by culture.
Prior Medication:
Allowed:
* Topical suppressive antifungal agents.
Exclusion Criteria
Patients with the following conditions or diseases are excluded:
* History of systemic fungal infection, including esophageal or systemic candidiasis, cryptococcosis, histoplasmosis, coccidioidomycosis, blastomycosis, sporotrichosis, or aspergillosis.
* Active systemic fungal infection at time of enrollment.
* Active superficial fungal infection at time of entry. (Such patients may be treated with topical antifungal agents and may be randomized if they are in clinical remission 14 days after completion of such therapy.)
Concurrent Medication:
Excluded:
* Amphotericin B.
* Fluconazole.
* Itraconazole.
* SCH 39304.
* Other systemic antifungals.
Patients with the following are excluded:
* Previous or currently active systemic fungal infection.
* History of allergy or intolerance to imidazole or azoles.
* Positive serum cryptococcal antigen titer at any dilution.
* Requiring multi-agent therapy for tuberculosis or for symptomatic Mycobacterium avium infection.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Bozzettee S
Role: STUDY_CHAIR
Powderly WG
Role: STUDY_CHAIR
Locations
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Stanford CRS
Palo Alto, California, United States
Ucsd, Avrc Crs
San Diego, California, United States
Ucsf Aids Crs
San Francisco, California, United States
Univ. of Miami AIDS CRS
Miami, Florida, United States
Northwestern University CRS
Chicago, Illinois, United States
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
New Orleans, Louisiana, United States
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States
Bmc Actg Crs
Boston, Massachusetts, United States
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, United States
University of Minnesota, ACTU
Minneapolis, Minnesota, United States
Washington U CRS
St Louis, Missouri, United States
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, United States
Memorial Sloan-Kettering Cancer Ctr.
New York, New York, United States
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, United States
Univ. of Rochester ACTG CRS
Rochester, New York, United States
Unc Aids Crs
Chapel Hill, North Carolina, United States
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, United States
Univ. of Cincinnati CRS
Cincinnati, Ohio, United States
Case CRS
Cleveland, Ohio, United States
The Ohio State Univ. AIDS CRS
Columbus, Ohio, United States
Pitt CRS
Pittsburgh, Pennsylvania, United States
University of Washington AIDS CRS
Seattle, Washington, United States
Mbeya Med. Research Program, Mbeya Referral Hosp. CRS
Mbeya, , Tanzania
Countries
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References
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Glick ME. CTG studies yield results. AIDS Clinical Trials Group. NIAID AIDS Agenda. 1995 Spring:8-9.
Hanna L. Treatment for HIV-related fungal infections. BETA. 1995 Jun:10-7.
Powderly WG. Fungal infections. Program Abstr Intersci Conf Antimicrob Agents Chemother. 1994 Oct 4-7:274
Powderly WG. Prophylaxis of fungal infection in HIV infection. Program Abstr Intersci Conf Antimicrob Agents Chemother. 1994 Oct 4-7:270
Powderly WG, Finkelstein D, Feinberg J, Frame P, He W, van der Horst C, Koletar SL, Eyster ME, Carey J, Waskin H, et al. A randomized trial comparing fluconazole with clotrimazole troches for the prevention of fungal infections in patients with advanced human immunodeficiency virus infection. NIAID AIDS Clinical Trials Group. N Engl J Med. 1995 Mar 16;332(11):700-5. doi: 10.1056/NEJM199503163321102.
Other Identifiers
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11504
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 981
Identifier Type: -
Identifier Source: org_study_id