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

Phase 1

Completed

• Conditions: HIV Infections

• Registration Number: NCT00000906
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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 Timeline

• Study First Submitted: 1999-11-02
• Study Completion: 2000-09
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (7)

Johns Hopkins Hosp; 🇺🇸 Baltimore, Maryland, United States

San Francisco Gen Hosp; 🇺🇸 San Francisco, California, United States

Univ of Colorado Health Sciences Ctr; 🇺🇸 Denver, Colorado, United States

Cornell Univ Med Ctr; 🇺🇸 New York, New York, United States

Chelsea Ctr; 🇺🇸 New York, New York, United States

Mount Sinai Med Ctr; 🇺🇸 New York, New York, United States

Beth Israel Med Ctr; 🇺🇸 New York, New York, United States