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)
Public ClinicalTrials.gov record NCT00000676. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00000676
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 500 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Not listed
- Completion
- Nov 1993 (Actual)
- Last update posted
- Nov 2, 2021
Ends 1993
United States locations
- U.S. sites
- 25
- U.S. states
- 14
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stanford CRS | Palo Alto | California | — | — |
| Ucsd, Avrc Crs | San Diego | California | 92093 | — |
| Ucsf Aids Crs | San Francisco | California | — | — |
| Univ. of Miami AIDS CRS | Miami | Florida | 33136 | — |
| Northwestern University CRS | Chicago | Illinois | — | — |
| Rush Univ. Med. Ctr. ACTG CRS | Chicago | Illinois | — | — |
| Indiana Univ. School of Medicine, Infectious Disease Research Clinic | Indianapolis | Indiana | 46202 | — |
| Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU | New Orleans | Louisiana | — | — |
| Johns Hopkins Adult AIDS CRS | Baltimore | Maryland | 21287 | — |
| Bmc Actg Crs | Boston | Massachusetts | 02118 | — |
| Beth Israel Deaconess - East Campus A0102 CRS | Boston | Massachusetts | 02215 | — |
| Beth Israel Deaconess Med. Ctr., ACTG CRS | Boston | Massachusetts | 02215 | — |
| University of Minnesota, ACTU | Minneapolis | Minnesota | 55455 | — |
| Washington U CRS | St Louis | Missouri | — | — |
| SUNY - Buffalo, Erie County Medical Ctr. | Buffalo | New York | 14215 | — |
| Memorial Sloan-Kettering Cancer Ctr. | New York | New York | 10021 | — |
| Beth Israel Med. Ctr. (Mt. Sinai) | New York | New York | — | — |
| Univ. of Rochester ACTG CRS | Rochester | New York | — | — |
| Unc Aids Crs | Chapel Hill | North Carolina | — | — |
| Duke Univ. Med. Ctr. Adult CRS | Durham | North Carolina | 27710 | — |
| Univ. of Cincinnati CRS | Cincinnati | Ohio | — | — |
| Case CRS | Cleveland | Ohio | 44106 | — |
| The Ohio State Univ. AIDS CRS | Columbus | Ohio | 43210 | — |
| Pitt CRS | Pittsburgh | Pennsylvania | 15213 | — |
| University of Washington AIDS CRS | Seattle | Washington | 98122 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00000676, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 2, 2021 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00000676 live on ClinicalTrials.gov.