Status:
COMPLETED
A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients With Recurrent Thrush
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Washington University School of Medicine
Conditions:
Candidiasis, Oral
HIV Infections
Eligibility:
All Genders
13+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether it is better to treat patients with fluconazole on a continuous basis to prevent thrush (yeast infection in the mouth) from coming back or to wait and...
Detailed Description
This study will evaluate two different management strategies for patients with advanced HIV infection who are at risk for recurrent and fluconazole-refractory oropharyngeal candidiasis. The treatment ...
Eligibility Criteria
Inclusion Criteria
You may be eligible for this study if you:
- Are HIV-positive.
- Have a CD4+ cell count less than 150 cells/mm3.
- Had at least one episode of thrush in the 24 months before study entry.
- Have a life expectancy of at least 12 months.
- Weigh at least 88 pounds.
- Are 13 years of age or older (consent of parent or guardian required if under 18).
- Agree to practice abstinence or use effective methods of birth control during the study.
Exclusion Criteria
You will not be eligible for this study if you:
- Have an allergy to azoles.
- Have had 3 episodes or more of thrush within 12 weeks of study entry.
- Have a history of esophageal candidiasis.
- Have a history of fluconazole-resistant infection.
- Have an active opportunistic infection requiring treatment within 14 days before study entry.
- Have a fungal infection requiring certain medications.
- Have a severe liver disease (e.g., cirrhosis).
- Are unable to tolerate oral medications.
- Take certain medications.
- Are pregnant or breast-feeding.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
May 1 2002
Estimated Enrollment :
948 Patients enrolled
Trial Details
Trial ID
NCT00000951
End Date
May 1 2002
Last Update
October 29 2021
Active Locations (54)
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1
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
2
UCLA CARE Ctr
Los Angeles, California, United States, 90095
3
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
4
San Francisco Gen Hosp
San Francisco, California, United States, 941102859