Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients
NCT ID: NCT00000906
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2000-09-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Ritonavir
Saquinavir
Methadone hydrochloride
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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John G. Gerber
Role: STUDY_CHAIR
Joseph Gal
Role: STUDY_CHAIR
Locations
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San Francisco Gen Hosp
San Francisco, California, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States
Johns Hopkins Hosp
Baltimore, Maryland, United States
Beth Israel Med Ctr
New York, New York, United States
Chelsea Ctr
New York, New York, United States
Cornell Univ Med Ctr
New York, New York, United States
Mount Sinai Med Ctr
New York, New York, United States
Countries
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References
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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. doi: 10.1097/00126334-200106010-00010.
Other Identifiers
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11357
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 401
Identifier Type: -
Identifier Source: org_study_id