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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ritonavir
Saquinavir
Methadone hydrochloride
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Methadone, HIV-1, Dose-Response Relationship, Drug, Drug Interactions, Drug Therapy, Combination, Saquinavir, Adolescent Behavior, HIV Protease Inhibitors, Ritonavir, Narcotics, Substance-Related Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • San Francisco Gen Hosp
  • Univ of Colorado Health Sciences Ctr
  • Johns Hopkins Hosp
  • Beth Israel Med Ctr
  • Chelsea Ctr
  • Cornell Univ Med Ctr
  • Mount Sinai Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000906
Brief Title
Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients
Official Title
The Effect of HIV Protease Inhibitors on the Stereospecific Metabolism of Methadone in HIV-Infected Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2000 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Methadone, HIV-1, Dose-Response Relationship, Drug, Drug Interactions, Drug Therapy, Combination, Saquinavir, Adolescent Behavior, HIV Protease Inhibitors, Ritonavir, Narcotics, Substance-Related Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
12 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ritonavir
Intervention Type
Drug
Intervention Name(s)
Saquinavir
Intervention Type
Drug
Intervention Name(s)
Methadone hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John G. Gerber
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Joseph Gal
Official's Role
Study Chair
Facility Information:
Facility Name
San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
941102859
Country
United States
Facility Name
Univ of Colorado Health Sciences Ctr
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Beth Israel Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Chelsea Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Cornell Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11404537
Citation
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; ACTG 401 Study Team. 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. doi: 10.1097/00126334-200106010-00010.
Results Reference
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Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients

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