Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients - Full Text View

Sponsored by:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000906

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Ritonavir Drug: Saquinavir Drug: Methadone hydrochloride	Phase I

Study Type:	Interventional
Study Design:	Treatment, Dose Comparison, Bio-availability Study
Official Title:	The Effect of HIV Protease Inhibitors on the Stereospecific Metabolism of Methadone in HIV-Infected Subjects

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Methadone Saquinavir Saquinavir mesylate Ritonavir Methadone hydrochloride

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:	12
Study Start Date:	January 1998

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000906

Locations

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

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair:	John G. Gerber
Study Chair:	Joseph Gal

More Information

Additional Information:

Click here for more information about Saquinavir This link exits the ClinicalTrials.gov site

Click here for more information about Ritonavir This link exits the ClinicalTrials.gov site

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. 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.

Study ID Numbers:	ACTG 401
Study First Received:	November 2, 1999
Last Updated:	July 11, 2008
ClinicalTrials.gov Identifier:	NCT00000906 History of Changes
Health Authority:	United States: Federal Government

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

Methadone
HIV-1
Dose-Response Relationship, Drug
Drug Interactions
Drug Therapy, Combination
Saquinavir

Adolescent Behavior
HIV Protease Inhibitors
Ritonavir
Narcotics
Substance-Related Disorders

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
HIV Protease Inhibitors
Anti-HIV Agents
Saquinavir
Acquired Immunodeficiency Syndrome
Central Nervous System Depressants
Narcotics
Antiviral Agents
Immunologic Deficiency Syndromes
Protease Inhibitors
Naphazoline
Virus Diseases

Methadone
Anti-Retroviral Agents
Guaifenesin
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Substance-Related Disorders
Peripheral Nervous System Agents
Analgesics
Phenylpropanolamine
Retroviridae Infections
Analgesics, Opioid

Additional relevant MeSH terms:

Anti-Infective Agents
Respiratory System Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Saquinavir
Physiological Effects of Drugs
Infection
Anti-Retroviral Agents
Sensory System Agents
Therapeutic Uses
Analgesics
Retroviridae Infections
Analgesics, Opioid
RNA Virus Infections

HIV Protease Inhibitors
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Central Nervous System Depressants
Enzyme Inhibitors
Narcotics
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
Methadone
HIV Infections
Ritonavir

ClinicalTrials.gov processed this record on July 02, 2009