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)

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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 usuall...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• 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.
• • Exclusion Criteria
• 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.

Trial Officials