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)

Completed · Phase 3

Conditions studied: Candidiasis, Mycoses, HIV Infections

In brief

To study the effectiveness, safety, and tolerance of fluconazole versus clotrimazole troches (lozenges) as prophylaxis (preventive treatment) against fungal infections in patients enrolled in ACTG 081 (a study of prophylaxis against pneumocystosis, toxoplasmosis, and serious bacterial infection). Primarily, to compare the rates of invasive infections by C. neoformans, endemic mycoses, and Candida. To compare the mortality rates due to fungal infections between two antifungal prophylactic treatments. Secondarily, to assess the effect of prophylaxis on the incidence of severe fungal infections, defined as invasive infections and esophageal candidiasis and less severe mucocutaneous infection. 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.

Key facts

Study ID: NCT00000676
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 500
Expected to finish: 1993-11-01
Last updated by the study team: 2021-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Concurrent Medication:
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.

You may not qualify if…

Co-existing Condition:
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.

Where it is running

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

Full record on ClinicalTrials.gov

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