NCT00002294

Brief Summary

To compare the safety and effectiveness of fluconazole with that of placebo as maintenance treatment for preventing the relapse of cryptococcal meningitis in patients with AIDS.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 1989

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Meningitis, CryptococcalHIV Infections

Keywords

AIDS-Related Opportunistic InfectionsMeningitisCryptococcosisFluconazoleAcquired Immunodeficiency Syndrome

Interventions

FluconazoleDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Antiviral therapy (e.g., zidovudine).
  • Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia (PCP).
  • Concurrent Treatment:
  • Allowed:
  • Radiation therapy for mucocutaneous Kaposi's sarcoma.
  • Patients must be oriented to person, place, and time and able to give written informed consent.
  • Patients must have had an acute episode of cryptococcal meningitis that was documented by recovery and identification of cryptococcus from lumbar cerebrospinal fluid (CSF) culture within 4 months of study entry.
  • Adequate therapy will consist of 6 - 16 weeks of treatment with amphotericin B alone, amphotericin B + oral flucytosine, or a period of the combination followed by amphotericin alone. Adequate regimens will include:
  • A minimum total amphotericin B dose of 2 grams as monotherapy.
  • weeks of flucytosine at 150 mg/kg/day (or levels of 20 to 100 mcg/ml demonstrated) plus amphotericin B at an average daily dose of at least 0.3 mg/kg/day or to a total dose of 1 gram.
  • After a shorter period of the combination amphotericin/flucytosine therapy, an additional Y grams of amphotericin B monotherapy will make therapy adequate where Y = 2 gm-(X weeks combination therapy / 3 weeks).
  • For example, a patient who received 3 weeks of combination followed by amphotericin alone would need an additional 2 gm - 3 weeks/3 weeks = 1 gm of amphotericin B.
  • Patients need not be receiving amphotericin B at the time of randomization but must begin study maintenance therapy within 3 weeks of cessation of primary amphotericin B therapy.
  • +4 more criteria

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following are excluded:
  • Clinical evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
  • History of allergy or intolerance of imidazoles, azoles, or amphotericin B.
  • Moderate or severe liver disease.
  • Concurrent Medication:
  • Excluded:
  • Intrathecal amphotericin B.
  • Coumarin-type anticoagulants.
  • Oral hypoglycemics.
  • Barbiturates.
  • Phenytoin.
  • Immunostimulants.
  • Investigational drugs or approved (licensed) drugs for investigational indications.
  • Concurrent Treatment:
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Dr Robert Larsen

Los Angeles, California, 90033, United States

Location

UCI Med Ctr

Orange, California, 92668, United States

Location

UCSD

San Diego, California, 92103, United States

Location

Dr Paul Rothman

Sherman Oaks, California, 91403, United States

Location

Stanford Univ School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Meningitis, CryptococcalHIV InfectionsAIDS-Related Opportunistic InfectionsMeningitisCryptococcosisAcquired Immunodeficiency Syndrome

Interventions

Fluconazole

Condition Hierarchy (Ancestors)

Meningitis, FungalCentral Nervous System Fungal InfectionsMycosesBacterial Infections and MycosesInfectionsCentral Nervous System InfectionsCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory DiseasesBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesOpportunistic InfectionsSlow Virus Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1989-12

Locations

US(5)