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Safety and Effectiveness of Fluconazole Versus SCH 56592 to Treat Thrush in HIV-Positive Patients

Primary Purpose

Candidiasis, Oral, HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Posaconazole
Fluconazole
Sponsored by
Schering-Plough
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Candidiasis, Oral focused on measuring AIDS-Related Opportunistic Infections, Fluconazole, Administration, Oral, Antifungal Agents, Candidiasis, Oral, Pharyngeal Diseases, posaconazole

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria You may be eligible for this study if you: Are at least 18 years old. Are HIV-positive. Have thrush (oropharyngeal candidiasis). Agree to practice sexual abstinence or use effective barrier methods of birth control (e.g., condoms). Are able to take study medication and return for clinic visits during the study. Are expected to live for at least 2 months. Exclusion Criteria You will not be eligible for this study if you: Have received protease inhibitors for the first time within 30 days prior to study entry. Have received certain medications. Have certain other types of fungal infections. Have certain types of cancer. Have received SCH 56592 within 3 months prior to study entry. Are pregnant or breast-feeding. Cannot take medications by mouth. Are allergic to azole drugs. Have certain medical conditions. Have been in this study before.

Sites / Locations

  • East Bay AIDS Ctr
  • ViRx Inc
  • Kaiser Foundation Hospital
  • Infectious Disease and AIDS Clinic
  • Dupont Circle Physicians Group
  • Boulevard Comprehensive Care Ctr
  • Miami Veterans Administration Med Ctr
  • TRIAD Health Practice
  • Community Hosp Indianapolis
  • Wayne State Univ / Harper Hosp
  • UMDNJ - New Jersey Med School / Cooper Hosp
  • Jersey City Med Ctr
  • SUNY / Health Science Ctr at Brooklyn
  • Univ of Pennsylvania School of Dental Medicine
  • Med Univ of South Carolina
  • Amelia Ct Clinic
  • Univ of Texas Health Sciences Ctr
  • Queen Elizabeth Hosp Respiratory Unit

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Schering-Plough
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1. Study Identification

Unique Protocol Identification Number
NCT00002446
Brief Title
Safety and Effectiveness of Fluconazole Versus SCH 56592 to Treat Thrush in HIV-Positive Patients
Official Title
Randomized, Controlled Trial of SCH 56592 Oral Suspension Versus Fluconazole Suspension in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2000
Overall Recruitment Status
Completed
Study Start Date
August 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Schering-Plough

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to compare the safety and effectiveness of 2 treatments for thrush (a fungal infection of the mouth and throat) in HIV-positive patients. Fluconazole is a drug that is commonly used to treat thrush. SCH 56592 is a new drug that will be compared to fluconazole.
Detailed Description
Patients receive SCH 56592 oral suspension or fluconazole suspension for 14 days. Patients remain on study for 44 days total and are monitored for safety and efficacy of study treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis, Oral, HIV Infections
Keywords
AIDS-Related Opportunistic Infections, Fluconazole, Administration, Oral, Antifungal Agents, Candidiasis, Oral, Pharyngeal Diseases, posaconazole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Posaconazole
Intervention Type
Drug
Intervention Name(s)
Fluconazole

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria You may be eligible for this study if you: Are at least 18 years old. Are HIV-positive. Have thrush (oropharyngeal candidiasis). Agree to practice sexual abstinence or use effective barrier methods of birth control (e.g., condoms). Are able to take study medication and return for clinic visits during the study. Are expected to live for at least 2 months. Exclusion Criteria You will not be eligible for this study if you: Have received protease inhibitors for the first time within 30 days prior to study entry. Have received certain medications. Have certain other types of fungal infections. Have certain types of cancer. Have received SCH 56592 within 3 months prior to study entry. Are pregnant or breast-feeding. Cannot take medications by mouth. Are allergic to azole drugs. Have certain medical conditions. Have been in this study before.
Facility Information:
Facility Name
East Bay AIDS Ctr
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
ViRx Inc
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Kaiser Foundation Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Infectious Disease and AIDS Clinic
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Dupont Circle Physicians Group
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
200091104
Country
United States
Facility Name
Boulevard Comprehensive Care Ctr
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Miami Veterans Administration Med Ctr
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
TRIAD Health Practice
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Community Hosp Indianapolis
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46219
Country
United States
Facility Name
Wayne State Univ / Harper Hosp
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
UMDNJ - New Jersey Med School / Cooper Hosp
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Jersey City Med Ctr
City
Jersey City
State/Province
New Jersey
ZIP/Postal Code
07304
Country
United States
Facility Name
SUNY / Health Science Ctr at Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Univ of Pennsylvania School of Dental Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Med Univ of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Amelia Ct Clinic
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Univ of Texas Health Sciences Ctr
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Facility Name
Queen Elizabeth Hosp Respiratory Unit
City
St Michael
Country
Barbados

12. IPD Sharing Statement

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Safety and Effectiveness of Fluconazole Versus SCH 56592 to Treat Thrush in HIV-Positive Patients

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