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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000788 |
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.
Condition | Intervention | Phase |
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Candidiasis HIV Infections |
Drug: Methadone hydrochloride Drug: Fluconazole |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety Study |
Official Title: | A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone |
Estimated Enrollment: | 24 |
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.
Patients are randomized to receive methadone plus either fluconazole or placebo in clinic daily for 16 days. Study drugs are administered as close to 8 AM as possible. Patients must visit the Fort Greene clinic on study days 1, 2, 15, and 16; they may receive treatment at their home clinics on days 3 through 14.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
NOTE:
NOTE:
Prior Medication:
Required:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded within 30 days prior to study entry:
Alcohol or illicit drug abuse.
Study ID Numbers: | CPCRA 030 |
Study First Received: | November 2, 1999 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00000788 |
Health Authority: | United States: Federal Government |
Methadone Drug Interactions Drug Therapy, Combination Fluconazole |
Antifungal Agents Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Fluconazole Sexually Transmitted Diseases, Viral Candidiasis Clotrimazole Miconazole Acquired Immunodeficiency Syndrome Tioconazole AIDS-Related Complex Immunologic Deficiency Syndromes Naphazoline |
Virus Diseases Oxymetazoline Methadone Mycoses Guaifenesin Phenylephrine HIV Infections Sexually Transmitted Diseases Phenylpropanolamine Retroviridae Infections |
Anti-Infective Agents Respiratory System Agents RNA Virus Infections Slow Virus Diseases Immune System Diseases Physiological Effects of Drugs Central Nervous System Depressants Narcotics Infection Pharmacologic Actions |
Sensory System Agents Antifungal Agents Therapeutic Uses Lentivirus Infections Peripheral Nervous System Agents Analgesics Antitussive Agents Central Nervous System Agents Analgesics, Opioid |