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

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Ritonavir (Drug); Saquinavir (Drug); Methadone hydrochloride (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
John G. Gerber, Study Chair
Joseph Gal, Study Chair


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.

Clinical Details

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

Study design: Endpoint Classification: Bio-availability Study, Primary Purpose: 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

San Francisco Gen Hosp, San Francisco, California 941102859, United States

Univ of Colorado Health Sciences Ctr, Denver, Colorado 80262, United States

Johns Hopkins Hosp, Baltimore, Maryland 21287, United States

Beth Israel Med Ctr, New York, New York 10003, United States

Chelsea Ctr, New York, New York 10021, United States

Cornell Univ Med Ctr, New York, New York 10021, United States

Mount Sinai Med Ctr, New York, New York 10029, United States

Additional Information

Click here for more information about Saquinavir

Click here for more information about Ritonavir

Related 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; 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.

Last updated: February 16, 2012

Page last updated: August 23, 2015

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