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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

Phase 4
13 Years
Not Enrolling
Candidiasis, Oral, HIV Infections

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Trial Information

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

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.

Inclusion 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

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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Principal Investigator

Mitchell Goldman

Investigator Role:

Study Chair


United States: Federal Government

Study ID:

ACTG 323



Start Date:

Completion Date:

May 2002

Related Keywords:

  • Candidiasis, Oral
  • HIV Infections
  • AIDS-Related Opportunistic Infections
  • Fluconazole
  • Antifungal Agents
  • Candidiasis, Oral
  • Drug Administration Schedule
  • Pharyngeal Diseases
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Candidiasis
  • Candidiasis, Oral
  • HIV Seropositivity



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