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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000906
• Other study ID #: ACTG 401
• Secondary ID: 11357
• Status: Completed
• Phase: Phase 1
• Est. completion date: September 2000

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2000
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Ritonavir

• Saquinavir

• Methadone hydrochloride

Locations

Country	Name	City	State
United States	Johns Hopkins Hosp	Baltimore	Maryland
United States	Univ of Colorado Health Sciences Ctr	Denver	Colorado
United States	Beth Israel Med Ctr	New York	New York
United States	Chelsea Ctr	New York	New York
United States	Cornell Univ Med Ctr	New York	New York
United States	Mount Sinai Med Ctr	New York	New York
United States	San Francisco Gen Hosp	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation