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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000906
First received: November 2, 1999
Last updated: February 16, 2012
Last verified: February 2012
History of Changes
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
Primary Purpose: Treatment
Official Title: The Effect of HIV Protease Inhibitors on the Stereospecific Metabolism of Methadone in HIV-Infected Subjects

Resource links provided by NLM:

U.S. FDA Resources

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

Estimated Enrollment: 12
Study Completion Date: September 2000
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
Mount Sinai Med Ctr
New York, New York, United States, 10029
Cornell Univ Med Ctr
New York, New York, United States, 10021
Beth Israel Med Ctr
New York, New York, United States, 10003
Chelsea Ctr
New York, New York, United States, 10021
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:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000906     History of Changes
Other Study ID Numbers: ACTG 401, 11357
Study First Received: November 2, 1999
Last Updated: February 16, 2012
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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Methadone
Protease Inhibitors
Saquinavir
Ritonavir
 HIV Protease Inhibitors
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013