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Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)


Phase 3
18 Years
N/A
Not Enrolling
Both
Candidiasis, Mycoses, HIV Infections

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Trial Information

Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)


Serious fungal infections are significant complicating and life-threatening occurrences in
patients with advanced HIV infection. Oropharyngeal candidiasis is found in almost all such
patients, and causes pain, difficulty in swallowing, and loss of appetite. Similarly,
esophageal candidiasis causes illness in the population. Cryptococcosis, endemic mycoses,
and coccidioidomycosis also cause significant illness and death in AIDS patients. Once
established, fungal infections in AIDS patients generally require continuous suppressive
therapy because attempts at curing these infections are usually unsuccessful. Fluconazole
has a number of characteristics that would make it a logical candidate to examine as a
prophylactic agent in patients with advanced HIV infection. Animal studies have shown it to
be prophylactic in models of candidiasis, cryptococcosis, histoplasmosis, and
coccidioidomycosis. Initial experience in patients with active cryptococcal meningitis
appears favorable, and studies of oropharyngeal candidiasis show it to be effective.

AMENDED: 11/01/90 Sufficient numbers of patients will be enrolled from all centers starting
at week 8 of participation in the parent study to achieve a total of 240 evaluable patients
who will remain in the nested study for a maximum duration of 45 months. Enrollment will
continue until all eligible and interested 081 patients are enrolled. Fungal prophylaxis
will begin at the time of enrollment into the nested study and will continue until an
efficacy or safety end point is reached, until withdrawal from the nested study, or until
death.

Original design: Patients included are those already enrolled in ACTG 081. Patients are
enrolled from all centers at either week 8, 12, 16, 20, 24, 28, or 32 of participation in
the parent study. They are randomized to receive either oral fluconazole or clotrimazole
troches. Prophylaxis continues until a serious fungal infection develops, the end of the
parent study is reached (which is expected to be December 1991), the patient withdraws from
either the nested or parent study, or the patient dies. Clinical examination is performed at
2 weeks and then monthly (or more if clinically indicated) for the duration of antifungal
prophylaxis; the schedule of evaluation is the same as for the parent study. There is a
1-month postprophylaxis follow-up after discontinuation of prophylaxis for any reason.

Inclusion Criteria


Inclusion Criteria

Concurrent Medication:

Required:

- Zidovudine (AZT).

- Antipneumocystis prophylaxis.

Allowed:

- Topical suppressive antifungal agents.

Eligibility requirements are:

- Participation in NIAID ACTG 081.

- No history of systemic fungal infection, including esophageal or systemic
candidiasis, cryptococcosis, histoplasmosis, coccidioidomycosis, blastomycosis,
sporotrichosis, or aspergillosis.

- Willingness to sign an informed consent.

- Transaminases < 5 x upper limit of normal.

- Noncompliance will not be a reason for withdrawal of a patient from the study, unless
patient refuses further treatment.

Allowed:

- A history of oropharyngeal, vaginal or cutaneous candidiasis.

- Dermatophyte infections (i.e., tinea pedis) at entry but not active candida
infection. Sites of suspected dermatophyte involvement other than the feet should
have candida excluded by culture.

Prior Medication:

Allowed:

- Topical suppressive antifungal agents.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or diseases are excluded:

- History of systemic fungal infection, including esophageal or systemic candidiasis,
cryptococcosis, histoplasmosis, coccidioidomycosis, blastomycosis, sporotrichosis, or
aspergillosis.

- Active systemic fungal infection at time of enrollment.

- Active superficial fungal infection at time of entry. (Such patients may be treated
with topical antifungal agents and may be randomized if they are in clinical
remission 14 days after completion of such therapy.)

Concurrent Medication:

Excluded:

- Amphotericin B.

- Fluconazole.

- Itraconazole.

- SCH 39304.

- Other systemic antifungals.

Patients with the following are excluded:

- Previous or currently active systemic fungal infection.

- History of allergy or intolerance to imidazole or azoles.

- Positive serum cryptococcal antigen titer at any dilution.

- Requiring multi-agent therapy for tuberculosis or for symptomatic Mycobacterium avium
infection.

Type of Study:

Interventional

Study Design:

Primary Purpose: Prevention

Principal Investigator

Bozzettee S

Investigator Role:

Study Chair

Authority:

Unspecified

Study ID:

ACTG 981

NCT ID:

NCT00000676

Start Date:

Completion Date:

November 1993

Related Keywords:

  • Candidiasis
  • Mycoses
  • HIV Infections
  • Mycoses
  • Fluconazole
  • Clotrimazole
  • Antifungal Agents
  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • AIDS-Related Complex
  • Candidiasis
  • Mycoses

Name

Location

Stanford CRSPalo Alto, California  94305
Ucsd, Avrc CrsSan Diego, California  
Ucsf Aids CrsSan Francisco, California  
Univ. of Miami AIDS CRSMiami, Florida  33136
Northwestern University CRSChicago, Illinois  60611
Rush Univ. Med. Ctr. ACTG CRSChicago, Illinois  60612
Indiana Univ. School of Medicine, Infectious Disease Research ClinicIndianapolis, Indiana  46202
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTUNew Orleans, Louisiana  70112
Johns Hopkins Adult AIDS CRSBaltimore, Maryland  21287
Beth Israel Deaconess - East Campus A0102 CRSBoston, Massachusetts  02215
Beth Israel Deaconess Med. Ctr., ACTG CRSBoston, Massachusetts  02215
Bmc Actg CrsBoston, Massachusetts  02118
University of Minnesota, ACTUMinneapolis, Minnesota  
Washington U CRSSt. Louis, Missouri  
SUNY - Buffalo, Erie County Medical Ctr.Buffalo, New York  14215
Memorial Sloan-Kettering Cancer Ctr.New York, New York  10021
Beth Israel Med. Ctr. (Mt. Sinai)New York, New York  10003
Univ. of Rochester ACTG CRSRochester, New York  14642
Unc Aids CrsChapel Hill, North Carolina  27599
Duke Univ. Med. Ctr. Adult CRSDurham, North Carolina  27710
Univ. of Cincinnati CRSCincinnati, Ohio  45267
Case CRSCleveland, Ohio  44106
The Ohio State Univ. AIDS CRSColumbus, Ohio  43210
University of Washington AIDS CRSSeattle, Washington  98122
Pitt CRSPittsburgh, Pennsylvania  15213