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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00000906
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : February 17, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Ritonavir Drug: Saquinavir Drug: Methadone hydrochloride Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Primary Purpose: Treatment
Official Title: The Effect of HIV Protease Inhibitors on the Stereospecific Metabolism of Methadone in HIV-Infected Subjects
Study Completion Date : September 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000906

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
Beth Israel Med Ctr
New York, New York, United States, 10003
Chelsea Ctr
New York, New York, United States, 10021
Cornell Univ Med Ctr
New York, New York, United States, 10021
Mount Sinai Med Ctr
New York, New York, United States, 10029
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Study Chair: John G. Gerber
Study Chair: Joseph Gal
More Information

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000906     History of Changes
Other Study ID Numbers: ACTG 401
11357 ( Registry Identifier: DAIDS ES )
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: February 17, 2012
Last Verified: February 2012

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Dose-Response Relationship, Drug
Drug Interactions
Drug Therapy, Combination
Adolescent Behavior
HIV Protease Inhibitors
Substance-Related Disorders

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents