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NCT00000639 · ClinicalTrials.gov registry record · NA

A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis

A NA study of HIV Infections and Meningitis, Cryptococcal, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
NA
Development phase
400
Enrollment target
20
Study locations

NCT00000639: Completed NA study of HIV Infections and Meningitis, Cryptococcal, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00000639 is a NA study of HIV Infections and Meningitis, Cryptococcal that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 400 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (10% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00000639, a NA study of HIV Infections and Meningitis, Cryptococcal, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
NA
Development phase
400 participants
Enrollment target
20
Study locations

Study Summary

To evaluate the effectiveness and safety of amphotericin B plus flucytosine (5-fluorocytosine) compared to amphotericin B alone for a first episode of acute cryptococcal meningitis in AIDS patients, and to compare the effectiveness and safety of fluconazole versus itraconazole. At least 10 percent of patients with a low CD4 count and HIV infection will develop meningitis due to Cryptococcus neoformans. More effective treatments than the standard therapy need to be explored.

Conditions Studied

HIV Infections Meningitis, Cryptococcal

Interventions

  • DRUG Fluconazole
  • DRUG Itraconazole
  • DRUG Amphotericin B
  • DRUG Flucytosine

Study Locations (20)

New York

  • SUNY - Buffalo, Erie County Medical Ctr. - Buffalo
  • Beth Israel Med. Ctr. (Mt. Sinai) - New York
  • Cornell University A2201 - New York
  • Univ. of Rochester ACTG CRS - Rochester

Massachusetts

  • Massachusetts General Hospital ACTG CRS - Boston
  • Bmc Actg Crs - Boston
  • Beth Israel Deaconess Med. Ctr., ACTG CRS - Boston

North Carolina

  • Unc Aids Crs - Chapel Hill
  • Carolinas HealthCare System, Carolinas Med. Ctr. - Charlotte
  • Regional Center for Infectious Disease, Wendover Medical Center CRS - Greensboro

California

  • USC CRS - Los Angeles
  • Ucsf Aids Crs - San Francisco

Indiana

  • Indiana Univ. School of Medicine, Infectious Disease Research Clinic - Indianapolis
  • Methodist Hosp. of Indiana - Indianapolis

Missouri

  • St. Louis ConnectCare, Infectious Diseases Clinic - St Louis
  • Washington U CRS - St Louis

Florida

  • Univ. of Miami AIDS CRS - Miami

Hawaii

  • Univ. of Hawaii at Manoa, Leahi Hosp. - Honolulu

Trial Details

FieldValue
Enrollment Target 400 participants
Est. Completion 1997-09
Phase NA
National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

What the finished NCT00000639 record still lists

NCT00000639 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (10% lower).

The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 4 interventions - of which Fluconazole is the first listed.

NCT00000639 names 20 study sites across 10 states, led by New York, Massachusetts, North Carolina.

Frequently Asked Questions

What is clinical trial NCT00000639 about?

NCT00000639 is a clinical study titled "A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis". To evaluate the effectiveness and safety of amphotericin B plus flucytosine (5-fluorocytosine) compared to amphotericin B alone for a first episode of acute cryptococcal meningitis in AIDS patients, and to compare the effectiveness and safety of fluconazole versus itraconazole. At least 10 percent ...

What is the current status of trial NCT00000639?

This trial is currently completed. It is a NA study. The enrollment target is 400 participants. Estimated completion is 1997-09.

What conditions does trial NCT00000639 study?

This clinical trial studies the following conditions: HIV Infections, Meningitis, Cryptococcal.

What interventions are being tested in trial NCT00000639?

The interventions under investigation include: Fluconazole (DRUG), Itraconazole (DRUG), Amphotericin B (DRUG), Flucytosine (DRUG).

Who is sponsoring clinical trial NCT00000639?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00000639 being conducted?

This trial has 20 study locations across California, Florida, Hawaii, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for HIV Infections

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00000639's enrollment target sits among peer trials

400 80th of 542 higher than 460 of 542 other HIV Infections trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00000639, the US trial registry maintained by the National Library of Medicine. NCT00000639 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.