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

October 27, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 941102859
        • San Francisco Gen Hosp
    • Colorado
      • Denver, Colorado, United States, 80262
        • Univ of Colorado Health Sciences Ctr
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hosp
    • New York
      • New York, New York, United States, 10003
        • Beth Israel Med Ctr
      • New York, New York, United States, 10021
        • Cornell Univ Med Ctr
      • New York, New York, United States, 10029
        • Mount Sinai Med Ctr
      • New York, New York, United States, 10021
        • Chelsea Ctr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Joseph Gal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

September 1, 2000

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 401
  • 11357 (DAIDS ES)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Ritonavir

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe