Search / Trial NCT00000906

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Trial Information

Current as of December 06, 2024

Completed

Keywords

Methadone Hiv 1 Dose Response Relationship, Drug Drug Interactions Drug Therapy, Combination Saquinavir Adolescent Behavior Hiv Protease Inhibitors Ritonavir Narcotics Substance Related Disorders

ClinConnect Summary

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 inh...

Gender

ALL

Eligibility 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.

Trial Officials

John G. Gerber

Study Chair

Joseph Gal

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

New York, New York, United States

New York, New York, United States

New York, New York, United States

San Francisco, California, United States

Baltimore, Maryland, United States

Denver, Colorado, United States

New York, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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