Fluconazole Prophylaxis of Thrush in AIDS

NCT00001542 | Completed Phase 4

• 2 other identifiers: 96010896-I-0108
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is a placebo-controlled trial of intermittent fluconazole prophylaxis (200 mg orally three times a week) in the prevention of thrush.

Conditions

Acquired Immunodeficiency Syndrome; Candidiasis; Oral Candidiasis

Keywords

Candidiasis; Azole; Resistance; Candida Albicans; Oropharynx

Interventions

fluconazole DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

HIV infection previously documented by ELISA test kit and confirmed by either Western Blot, HIV antigen, HIV culture, or a second antibody test other than ELISA. Age 18 years or older. CD4 count of less than or equal to 150 cells/mm(3). At least one prior episode of health care provider diagnosed oropharyngeal candidiasis in the 6 months preceding enrollment. No allergy or intolerance to azoles. Less than 3 episodes of oropharyngeal candidiasis within the last 3 months. No history of esophageal candidiasis. No presence of systemic fungal infection requiring continuous antifungal therapy. No use of continuous azole treatment (i.e. daily, weekly, every other day, twice weekly fluconazole, itraconazole, ketoconazole or coltrimazole) for the prevention of fungal infections greater than or equal to 1 month within the past 6 months. No severe liver disease (ALT or AST greater than 5 times the upper limit of normal). No history of poorly responsive mucosal infection (i.e., requiring more than 200 mg of fluconazole daily or more than 14 days of therapy). Females may not be pregnant or lactating. Must have a negative pregnancy test within 2 weeks of enrollment. No one unlikely to survive more than 6 months. Must have ability to tolerate oral medications. No presence of active mucosal infection or symptoms of OPC/EC at time of initial assessment. (Note: Can enroll 2 weeks after resolution of the active episode). No patients currently being treated with azole for recent mucosal infection. (Note: These patients can enroll 2 weeks after the completion of azole therapy.) No presence of severe renal insufficiency as indicated by a serum creatinine greater than or equal to 3.0. Women must be taking appropriate birth control measures.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institute of Allergy and Infectious Diseases (NIAID)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 7854376 BACKGROUND

• Rex JH, Rinaldi MG, Pfaller MA. Resistance of Candida species to fluconazole. Antimicrob Agents Chemother. 1995 Jan;39(1):1-8. doi: 10.1128/AAC.39.1.1. No abstract available.

  PMID: 7695288 BACKGROUND

• Grant SM, Clissold SP. Fluconazole. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in superficial and systemic mycoses. Drugs. 1990 Jun;39(6):877-916. doi: 10.2165/00003495-199039060-00006.

  PMID: 2196167 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Candidiasis; Candidiasis, Oral

Interventions

Fluconazole

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mycoses; Bacterial Infections and Mycoses; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: May 22, 2002
• Study Start: July 1, 1996
• Study Completion: November 1, 2001
• Last Updated: March 4, 2008

Record last verified: 2001-11

Locations

US (1)