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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Page 1 of 14 (54 locations)

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