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

Study Description

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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 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.

Condition or disease	Intervention/treatment	Phase
Candidiasis, Oral; HIV Infections	Drug: Fluconazole	Phase 4

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 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	948 participants
Intervention Model:	Parallel Assignment
Primary Purpose:	Treatment
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
Actual Study Completion Date :	May 2002

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Ages Eligible for Study:	13 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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  Show 54 Study Locations

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Washington University School of Medicine

Investigators

Study Chair:	Mitchell Goldman
Study Chair:	Scott G. Filler

More Information

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Publications:

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.

Responsible Party:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000951 History of Changes
Other Study ID Numbers:	ACTG 323; 11297 ( Registry Identifier: DAIDS ES Registry Number )
First Posted:	August 31, 2001
Last Update Posted:	April 2, 2012
Last Verified:	March 2012

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

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

Additional relevant MeSH terms:

HIV Infections; Candidiasis; Candidiasis, Oral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mycoses; Mouth Diseases; Stomatognathic Diseases

Fluconazole; Antifungal Agents; Anti-Infective Agents; 14-alpha Demethylase Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Steroid Synthesis Inhibitors; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors