A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000744

Collaborator

Pfizer (Industry)

400

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief Summary

To compare the efficacy of fluconazole versus placebo for the prevention of Candida esophagitis and vaginal/oropharyngeal candidiasis, including a comparison of the development of clinical resistance.

Fluconazole has been shown to be effective in preventing or suppressing candidiasis in HIV-negative women. An increasing likelihood of oral and esophageal candidiasis in conjunction with progressive immunosuppression raises the question of the potential role of prophylactic antifungal therapy in high-risk persons.

Condition or Disease	Intervention/Treatment	Phase
Candidiasis Candidiasis, Esophageal HIV Infections	Drug: Fluconazole	N/A

Detailed Description

Four hundred HIV-infected women are randomized to receive fluconazole or placebo weekly for up to 2 years. Patients undergo follow-up every 3 months or more often if signs and symptoms of mucosal candidiasis occur.

Study Design

Study Type:

Interventional

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women

Actual Study Completion Date :

Dec 1, 1995

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria

Patients must have:

Evidence of HIV infection.
CD4+ count <= 300 cells/mm3 or <= 20 percent of total lymphocyte count.
Reasonably good health with a life expectancy of at least 6 months.
Pelvic exam including Pap smear or colposcopy performed within the past 90 days.

Prior Medication:

Allowed:

Topical or systemic treatment or prophylaxis with an antifungal agent.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

Current diagnosis of Candida esophagitis.
Known intolerance to azoles.

Concurrent Medication:

Excluded:

Systemic treatment or prophylaxis with an antifungal agent.

Patients with the following prior conditions are excluded:

Past history of Candida esophagitis.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Community Consortium of San Francisco	San Francisco	California	United States	94110
2	Denver CPCRA / Denver Public Hlth	Denver	Colorado	United States	80204
3	Wilmington Hosp / Med Ctr of Delaware	Wilmington	Delaware	United States	19899
4	Veterans Administration Med Ctr / Regional AIDS Program	Washington	District of Columbia	United States	20422
5	AIDS Research Consortium of Atlanta	Atlanta	Georgia	United States	30308
6	AIDS Research Alliance - Chicago	Chicago	Illinois	United States	60657
7	Louisiana Comm AIDS Rsch Prog / Tulane Univ Med	New Orleans	Louisiana	United States	70112
8	Comprehensive AIDS Alliance of Detroit	Detroit	Michigan	United States	48201
9	Henry Ford Hosp	Detroit	Michigan	United States	48202
10	North Jersey Community Research Initiative	Newark	New Jersey	United States	07103
11	Bronx Lebanon Hosp Ctr	Bronx	New York	United States	10456
12	Addiction Research and Treatment Corp	Brooklyn	New York	United States	11201
13	Clinical Directors Network of Region II	New York	New York	United States	10011
14	Harlem AIDS Treatment Group / Harlem Hosp Ctr	New York	New York	United States	10037
15	Portland Veterans Adm Med Ctr / Rsch & Education Grp	Portland	Oregon	United States	97210
16	Richmond AIDS Consortium	Richmond	Virginia	United States	23298