Know Cancer

or
forgot password

Comparison of Fluconazole (UK-49,858) and Amphotericin B for Maintenance Treatment of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome


Phase 3
18 Years
N/A
Not Enrolling
Both
Meningitis, Cryptococcal, HIV Infections

Thank you

Trial Information

Comparison of Fluconazole (UK-49,858) and Amphotericin B for Maintenance Treatment of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome


Cryptococcal meningitis is a life-threatening infectious complication of AIDS. Because
relapse after treatment occurs in over 50 percent of cases, chronic maintenance therapy with
intravenous (IV) amphotericin B is usually given. However, amphotericin B is not always
effective, has toxic effects, and must be given by the intravenous route. Fluconazole is an
antifungal agent that can be given orally and has been shown to be effective against
cryptococcal infections in animals and against acute CM in a few AIDS patients. Also, the
side effects experienced by over 2000 patients or volunteers given fluconazole have seldom
been severe enough to require withdrawal of the drug.

Patients accepted in the trial are randomly assigned to fluconazole or amphotericin B.
Fluconazole is given orally once a day and amphotericin B is given intravenously once a
week. Dosages depend on body weight. Medications may be given with amphotericin B to prevent
or reduce discomfort from associated side effects. Patients are treated for 12 months and
may continue to receive antiviral therapy, radiation therapy for mucocutaneous Kaposi's
sarcoma, or preventive therapy for Pneumocystis carinii pneumonia (PCP) during the study.

Inclusion Criteria


Inclusion Criteria

- HIV infection documented by antibody (ELISA on two occasions or ELISA with Western
blot confirmation), p24 antigen testing, or recovery of HIV in culture.

Prior Medication:

Required:

- Minimum total dose of 15 mg/kg of amphotericin B (either alone or in combination with
flucytosine) during primary therapy. End of primary therapy within 6 weeks of start
of maintenance therapy.

- Allowed:

- Past or present antiviral therapy and prophylaxis for Pneumocystis carinii pneumonia
(PCP).

- Pfizer must be notified if the patient is receiving ganciclovir at entry. Allowed
with amphotericin B to treat or prevent side effects.

- Antipyretics.

- Hydrocortisone.

- Meperidine.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

- Clinical evidence of acute or chronic meningitis other than cryptococcosis.

- Allergy or intolerance of imidazoles, azoles, or amphotericin B. Unable to take oral
medications reliably.

Patients with the following are excluded:

- Clinical evidence of acute or chronic meningitis other than cryptococcosis.

- Allergy or intolerance of imidazoles, azoles, or amphotericin B.

Prior Medication:

Excluded for more than 7 days after initiation of primary therapy for cryptococcosis:

- Ketoconazole.

- Fluconazole.

- Itraconazole.

- Miconazole.

- Any other systemic imidazole or azole.

- Excluded:

- Intrathecal amphotericin B.

- Coumadin-type anticoagulants.

- Oral hypoglycemics.

- Barbiturates.

- Phenytoin.

- Immunostimulants.

- Investigational drug or approved (licensed) drugs for investigational indications.

Prior Treatment:

Excluded:

- Lymphocyte replacement.

Type of Study:

Interventional

Study Design:

Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Principal Investigator

Armstrong D

Investigator Role:

Study Chair

Authority:

Unspecified

Study ID:

ACTG 026

NCT ID:

NCT00001017

Start Date:

Completion Date:

Related Keywords:

  • Meningitis, Cryptococcal
  • HIV Infections
  • AIDS-Related Opportunistic Infections
  • Meningitis
  • Injections, Intravenous
  • Cryptococcosis
  • Fluconazole
  • Administration, Oral
  • Acquired Immunodeficiency Syndrome
  • Amphotericin B
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Immunologic Deficiency Syndromes
  • Meningitis
  • Meningitis, Cryptococcal

Name

Location

Bellevue Hosp / New York Univ Med CtrNew York, New York  10016
Mem Sloan - Kettering Cancer CtrNew York, New York  10021
Saint Luke's - Roosevelt Hosp CtrNew York, New York  10025
Univ of Rochester Medical CenterRochester, New York  14642
Julio ArroyoWest Columbia, South Carolina  29169
UCLA CARE CtrLos Angeles, California  90095
Univ of Miami School of MedicineMiami, Florida  331361013
Indiana Univ HospIndianapolis, Indiana  462025250
Tulane Univ School of MedicineNew Orleans, Louisiana  70112
Harvard (Massachusetts Gen Hosp)Boston, Massachusetts  02114
Beth Israel Deaconess - West CampusBoston, Massachusetts  02215
Jack Weiler Hosp / Bronx Municipal HospBronx, New York  10465
Bronx Veterans Administration / Mount Sinai HospBronx, New York  10468
Montefiore Med Ctr / Bronx Municipal HospBronx, New York  10467
SUNY / Erie County Med Ctr at BuffaloBuffalo, New York  14215
City Hosp Ctr at Elmhurst / Mount Sinai HospElmhurst, New York  11373
Cornell Univ Med CtrNew York, New York  10021
Mount Sinai Med CtrNew York, New York  10029
Beth Israel Med Ctr / Peter Krueger ClinicNew York, New York  10003
SUNY - Stony BrookStony Brook, New York  117948153
Univ of North CarolinaChapel Hill, North Carolina  275997215
Duke Univ Med CtrDurham, North Carolina  27710
Holmes Hosp / Univ of Cincinnati Med CtrCincinnati, Ohio  452670405
Univ Hosp of Cleveland / Case Western Reserve UnivCleveland, Ohio  44106
Ohio State Univ Hosp ClinicColumbus, Ohio  432101228
Johns Hopkins HospBaltimore, Maryland  21287
North Central Bronx Hosp / Bronx Municipal HospBronx, New York  10467
Louisiana State Univ School of MedicineNew Orleans, Louisiana  70112