Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

November 2, 1999

Last Updated Date

July 11, 2008

Start Date ^ICMJE

January 1998

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00000906 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients

Official Title ^ICMJE

The Effect of HIV Protease Inhibitors on the Stereospecific Metabolism of Methadone in HIV-Infected Subjects

Brief Summary

The purpose of this study is to see if it is safe to combine methadone with two HIV protease inhibitors (PIs), ritonavir (RTV) and saquinavir (SQV), in HIV-infected patients not currently taking PIs. This study will measure the interactions between methadone and the PIs.

Methadone is used treat addicts and to treat severe pain. In order to find the safest way to use methadone with PIs, it is important to evaluate how they interact.

Detailed Description

Methadone is extensively used in the maintenance treatment of addicts and in the management of severe pain. In order to use methadone with HIV protease inhibitors correctly, it is important to evaluate and quantify interactions between the protease inhibitors and methadone.

Patients receive their usual daily dose of methadone followed with ritonavir and saquinavir, respectively, twice a day. Patients are evaluated on Day 4 for safety and tolerance, and their ritonavir dose is increased. On Day 8 patients are evaluated for a steady-state level of methadone. After 2 weeks of the protease inhibitor therapy, they return for methadone pharmacokinetic sampling at Day 15 over 24 hours. Both protease inhibitors and methadone are administered on Day 15 on an inpatient basis. On Day 30, patients are assessed for safety and tolerance.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Dose Comparison, Bio-availability Study

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Ritonavir
Drug: Saquinavir
Drug: Methadone hydrochloride

Study Arms / Comparison Groups

Publications *

Gerber JG, Rosenkranz S, Segal Y, Aberg J, D'Amico R, Mildvan D, Gulick R, Hughes V, Flexner C, Aweeka F, Hsu A, Gal J. Effect of ritonavir/saquinavir on stereoselective pharmacokinetics of methadone: results of AIDS Clinical Trials Group (ACTG) 401. J Acquir Immune Defic Syndr. 2001 Jun 1;27(2):153-60.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria

You may be eligible for this study if you:

Are HIV-positive and have an HIV RNA count below 100,000 copies/ml within 30 days prior to study entry.
Are taking methadone.
Are at least 18 years old.
Are within 40% of your ideal body weight and weigh at least 99 lbs.

Exclusion Criteria

You will not be eligible for this study if you:

Are allergic to or are unable to take RTV or SQV.
Have a history of treatment failure with indinavir, RTV, or SQV.
Have a history of certain illnesses that might prevent you from completing the study.
Have severe diarrhea or other stomach problems.
Have taken any PI within 4 weeks prior to study entry.
Would be unable to complete the study due to alcohol or drug abuse.
Are co-enrolled in other protocols that have you taking medications that are prohibited in this study.
Are taking PIs other than RTV or SQV.
Are receiving certain therapies or are taking certain medications, including experimental drugs.
Have an active opportunistic (AIDS-related) infection or disease that requires medication within 14 days prior to study entry.
Are pregnant or breast-feeding.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00000906

Responsible Party

Study ID Numbers ^ICMJE

ACTG 401

Study Sponsor ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:	John G. Gerber
Study Chair:	Joseph Gal

Information Provided By

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

October 2000

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP