Methadone Effects on Zidovudine (ZDV, AZT) Disposition

Status Completed

Clinical Trial Summary

To determine whether methadone maintenance alters the pharmacokinetics of zidovudine (AZT). To determine whether any such effect of methadone on disposition of AZT is time dependent and whether a metabolic interaction between AZT and methadone exists. Injection drug users represent an increasing proportion of HIV-infected persons. Since daily methadone maintenance is the major chemical treatment for injection drug abuse, it is important to determine the impact of methadone on AZT absorption, distribution, and elimination.

Clinical Trial Description

Injection drug users represent an increasing proportion of HIV-infected persons. Since daily methadone maintenance is the major chemical treatment for injection drug abuse, it is important to determine the impact of methadone on AZT absorption, distribution, and elimination. After 6 days of inpatient detoxification with clonidine, patients addicted to opiates are randomized to receive either oral or intravenous AZT for the first dose, followed by determination of plasma and urine pharmacokinetics. On the second day of AZT dosing, the alternate form of administration will be used for the first dose. On both days, all other doses are given orally. Patients then begin methadone maintenance in combination with AZT for 7 days of inpatient treatment, with further pharmacokinetic sampling. After hospitalization for 16 days total, patients continue AZT/methadone treatment on an outpatient basis, and then 2 months later are readmitted as inpatients for 5 days for further pharmacokinetic sampling. Control patients who are not addicted to opiates are hospitalized for 3 days at study entry and are randomized for AZT treatment and pharmacokinetic sampling in the same manner as the first group, although they will not receive methadone treatment. Control patients are readmitted for 2 days after 1 week of AZT treatment and then again after 59 days of AZT treatment. ;

Study Design

Related Conditions & MeSH terms

HIV Infections

Clinical Trial Details

NCT number	NCT00000800
Study type	Interventional
Source	National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status	Completed
Phase	Phase 1
Completion date	October 1998

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05454514` - Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS	N/A
Completed	`NCT03760458` - The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age	Phase 1/Phase 2
Completed	`NCT03141918` - Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS	N/A
Completed	`NCT03067285` - A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study	Phase 4
Recruiting	`NCT04579146` - Coronary Artery Disease (CAD) in Patients HIV-infected
Completed	`NCT06212531` - Papuan Indigenous Model of Male Circumcision	N/A
Active, not recruiting	`NCT03256422` - Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients	Phase 3
Completed	`NCT03256435` - Retention in PrEP Care for African American MSM in Mississippi	N/A
Completed	`NCT00517803` - Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies	N/A
Active, not recruiting	`NCT03572335` - Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
Completed	`NCT04165200` - Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV	N/A
Recruiting	`NCT03854630` - Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection	Phase 4
Terminated	`NCT03275571` - HIV, Computerized Depression Therapy & Cognition	N/A
Completed	`NCT02234882` - Study on Pharmacokinetics	Phase 1
Completed	`NCT01618305` - Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission	Phase 4
Recruiting	`NCT05043129` - Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
Not yet recruiting	`NCT05536466` - The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine	N/A
Recruiting	`NCT04985760` - Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy	Phase 1
Completed	`NCT05916989` - Stimulant Use and Methylation in HIV
Terminated	`NCT02116660` - Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)	Phase 2