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NCT00000951 Clinical Trial

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

HIV Infections Clinical Trial

Official title:
A Phase IV Randomized Study of the Use of Fluconazole as Chronic Suppressive Therapy Versus Episodic Therapy in HIV Positive Subjects With Recurrent Oropharyngeal Candidiasis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000951
Other study ID # ACTG 323
Secondary ID 11297
Status Completed
Phase Phase 4
First received
Last updated
Est. completion date May 2002

Study information
Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.

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 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.

Recruitment information / eligibility
Status Completed
Enrollment 948
Est. completion date May 2002
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 13 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Fluconazole

Locations
Country Name City State
Puerto Rico Univ of Puerto Rico San Juan
United States Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr Atlanta Georgia
United States Emory Univ Atlanta Georgia
United States Johns Hopkins Hosp Baltimore Maryland
United States State of MD Div of Corrections / Johns Hopkins Univ Hosp Baltimore Maryland
United States Boston Med Ctr Boston Massachusetts
United States Harvard (Massachusetts Gen Hosp) Boston Massachusetts
United States Albert Einstein College of Medicine Bronx New York
United States SUNY / Erie County Med Ctr at Buffalo Buffalo New York
United States Univ of North Carolina Chapel Hill North Carolina
United States Cook County Hosp Chicago Illinois
United States Louis A Weiss Memorial Hosp Chicago Illinois
United States Northwestern Univ Med School Chicago Illinois
United States Rush Presbyterian - Saint Luke's Med Ctr Chicago Illinois
United States Univ of Cincinnati Cincinnati Ohio
United States Univ of Kentucky Lexington Cincinnati Ohio
United States Case Western Reserve Univ Cleveland Ohio
United States MetroHealth Med Ctr Cleveland Ohio
United States Ohio State Univ Hosp Clinic Columbus Ohio
United States Univ of Colorado Health Sciences Ctr Denver Colorado
United States Duke Univ Med Ctr Durham North Carolina
United States Univ of Texas Galveston Galveston Texas
United States Queens Med Ctr Honolulu Hawaii
United States Univ of Hawaii Honolulu Hawaii
United States Division of Inf Diseases/ Indiana Univ Hosp Indianapolis Indiana
United States Indiana Univ Hosp Indianapolis Indiana
United States Methodist Hosp of Indiana / Life Care Clinic Indianapolis Indiana
United States Univ of Iowa Hosp and Clinic Iowa City Iowa
United States Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr Knoxville Tennessee
United States UCLA CARE Ctr Los Angeles California
United States Univ of Southern California / LA County USC Med Ctr Los Angeles California
United States Univ of Miami School of Medicine Miami Florida
United States Hennepin County Med Clinic Minneapolis Minnesota
United States Univ of Minnesota Minneapolis Minnesota
United States Bellevue Hosp / New York Univ Med Ctr New York New York
United States Beth Israel Med Ctr New York New York
United States Cornell Univ Med Ctr New York New York
United States Mem Sloan - Kettering Cancer Ctr New York New York
United States Mount Sinai Med Ctr New York New York
United States Saint Clare's Hosp and Health Ctr New York New York
United States St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr New York New York
United States Univ of Nebraska Med Ctr Omaha Nebraska
United States Philadelphia Veterans Administration Med Ctr Philadelphia Pennsylvania
United States Univ of Pennsylvania at Philadelphia Philadelphia Pennsylvania
United States St Mary's Hosp (Univ of Rochester/Infectious Diseases) Rochester New York
United States Univ of Rochester Medical Center Rochester New York
United States St Louis Regional Hosp / St Louis Regional Med Ctr Saint Louis Missouri
United States St Paul Ramsey Med Ctr Saint Paul Minnesota
United States Univ of California / San Diego Treatment Ctr San Diego California
United States San Francisco Gen Hosp San Francisco California
United States Univ of Washington Seattle Washington
United States Howard Univ Washington District of Columbia
United States Institute for Clinical Research Washington District of Columbia
United States Julio Arroyo West Columbia South Carolina

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Washington University School of Medicine

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (1)

Swindells S, Evans S, Zackin R, Goldman M, Haubrich R, Filler SG, Balfour HH Jr; AIDS Clinical Trial Group 722 Study Team. Predictive value of HIV-1 viral load on risk for opportunistic infection. J Acquir Immune Defic Syndr. 2002 Jun 1;30(2):154-8. — View Citation

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