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NCT00000788 · ClinicalTrials.gov registry record · Phase 1

A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone

A Phase 1 study of HIV Infections and Candidiasis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
24
Enrollment target
1
Study location

NCT00000788: Completed Phase 1 study of HIV Infections and Candidiasis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00000788 is a Phase 1 study of HIV Infections and Candidiasis that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 24 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00000788, a Phase 1 study of HIV Infections and Candidiasis, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target
1
Study location

Study Summary

To evaluate the pharmacokinetics and safety of concomitant administration of methadone and fluconazole. Injection drug users constitute the second largest subset of the U.S. population at risk for HIV infection and AIDS-associated mortality. Narcotic addiction is often treated by use of methadone. Fluconazole has been shown to be highly effective in treating symptomatic mucosal candidiasis, but it is unknown whether fluconazole affects methadone metabolism, which could result in symptoms of methadone withdrawal or overdose in patients taking the drugs in combination.

Interventions

  • DRUG Fluconazole
  • DRUG Methadone hydrochloride

Study Locations (1)

New York

  • Addiction Research and Treatment Corp - Brooklyn

Trial Details

FieldValue
Enrollment Target 24 participants
Est. Completion 1994-06
Phase Phase 1

What the finished NCT00000788 record still lists

NCT00000788 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (95% lower).

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

NCT00000788 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT00000788 about?

NCT00000788 is a clinical study titled "A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone". To evaluate the pharmacokinetics and safety of concomitant administration of methadone and fluconazole. Injection drug users constitute the second largest subset of the U.S. population at risk for HIV infection and AIDS-associated mortality. Narcotic addiction is often treated by use of methadone. ...

What is the current status of trial NCT00000788?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. Estimated completion is 1994-06.

What conditions does trial NCT00000788 study?

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

What interventions are being tested in trial NCT00000788?

The interventions under investigation include: Fluconazole (DRUG), Methadone hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00000788?

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 NCT00000788 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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 NCT00000788's enrollment target sits among peer trials

24 470th of 542 higher than 64 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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Source: ClinicalTrials.gov NCT00000788, the US trial registry maintained by the National Library of Medicine. NCT00000788 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.