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NCT00000951

A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients With Recurrent Thrush

Last Updated: 2021-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

948 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2002-05-31

Brief Summary

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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 treat each episode of thrush.

Fluconazole is one of the most commonly prescribed drugs to treat thrush and other yeast infections. However, the number of patients with fluconazole-resistant thrush is increasing, and it is not known whether continuous or intermittent use of fluconazole leads to greater resistance. Therefore, it is important to determine the most effective treatment strategy.

Detailed Description

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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 duration will be at least 24 months in order to evaluate the long-term effects of the treatment strategies on the development of fluconazole-refractory thrush. In addition to investigating antifungal treatment as it relates to fluconazole-refractory infections, the study will evaluate host factors and organism-related factors in order to increase our understanding of the pathogenesis of oropharyngeal candidiasis and fluconazole-refractory infections.

Prior to randomization to a long-term management strategy using fluconazole, patients are stratified into one of three groups according to their baseline CD4+ count (cells/mm3): 0-49, 50-100, and 101-150. Patients without oropharyngeal candidiasis (no thrush present) at enrollment and those patients who respond (no thrush present) to the initial acute therapy for an active infection are randomized 1:1 to one of two management strategies for fluconazole: Arm A (episodic therapy) or Arm B (chronic suppressive therapy with continuous fluconazole). Patients are then followed for a duration of 24 months after enrollment of the last subject. Patients with active oropharyngeal candidiasis at time of enrollment will be treated with fluconazole for up to 2 weeks and patients who respond (no thrush present) are then randomized to a long-term management strategy. Those who do not respond (refractory disease) to the acute treatment are permanently discontinued from the study. Women in both groups will have the option of being treated for vulvovaginal candidiasis either through or outside the study.

Conditions

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Candidiasis, Oral HIV Infections

Keywords

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AIDS-Related Opportunistic Infections Fluconazole Antifungal Agents Candidiasis, Oral Drug Administration Schedule Pharyngeal Diseases

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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Fluconazole

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mitchell Goldman

Role: STUDY_CHAIR

Scott G. Filler

Role: STUDY_CHAIR

Locations

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Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, United States

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UCLA CARE Ctr

Los Angeles, California, United States

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Univ of California / San Diego Treatment Ctr

San Diego, California, United States

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San Francisco Gen Hosp

San Francisco, California, United States

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Univ of Colorado Health Sciences Ctr

Denver, Colorado, United States

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Howard Univ

Washington D.C., District of Columbia, United States

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Institute for Clinical Research

Washington D.C., District of Columbia, United States

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Univ of Miami School of Medicine

Miami, Florida, United States

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Emory Univ

Atlanta, Georgia, United States

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Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr

Atlanta, Georgia, United States

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Queens Med Ctr

Honolulu, Hawaii, United States

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Univ of Hawaii

Honolulu, Hawaii, United States

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Northwestern Univ Med School

Chicago, Illinois, United States

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Cook County Hosp

Chicago, Illinois, United States

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Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, United States

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Louis A Weiss Memorial Hosp

Chicago, Illinois, United States

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Indiana Univ Hosp

Indianapolis, Indiana, United States

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Division of Inf Diseases/ Indiana Univ Hosp

Indianapolis, Indiana, United States

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Methodist Hosp of Indiana / Life Care Clinic

Indianapolis, Indiana, United States

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Univ of Iowa Hosp and Clinic

Iowa City, Iowa, United States

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State of MD Div of Corrections / Johns Hopkins Univ Hosp

Baltimore, Maryland, United States

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Johns Hopkins Hosp

Baltimore, Maryland, United States

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Harvard (Massachusetts Gen Hosp)

Boston, Massachusetts, United States

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Boston Med Ctr

Boston, Massachusetts, United States

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Hennepin County Med Clinic

Minneapolis, Minnesota, United States

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Univ of Minnesota

Minneapolis, Minnesota, United States

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St Paul Ramsey Med Ctr

Saint Paul, Minnesota, United States

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St Louis Regional Hosp / St Louis Regional Med Ctr

St Louis, Missouri, United States

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Univ of Nebraska Med Ctr

Omaha, Nebraska, United States

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