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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 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.
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.
Conditions Studied
Interventions
- DRUG Fluconazole
- DRUG Methadone hydrochloride
Study Locations (1)
New York
- Addiction Research and Treatment Corp - Brooklyn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Est. Completion | 1994-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000788
The ClinicalTrials.gov registry entry for NCT00000788 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (95% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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