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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000906 |
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 |
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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 |
Estimated Enrollment: | 12 |
Study Start Date: | January 1998 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
You may be eligible for this study if you:
Exclusion Criteria
You will not be eligible for this study if you:
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 |
Study Chair: | John G. Gerber | |
Study Chair: | Joseph Gal |
Study ID Numbers: | ACTG 401 |
Study First Received: | November 2, 1999 |
Last Updated: | July 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00000906 |
Health Authority: | United States: Federal Government |
Methadone HIV-1 Dose-Response Relationship, Drug Drug Interactions Drug Therapy, Combination Saquinavir |
Adolescent Behavior HIV Protease Inhibitors Ritonavir Narcotics Substance-Related Disorders |
Sexually Transmitted Diseases, Viral Saquinavir Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Virus Diseases Naphazoline Oxymetazoline Methadone |
Guaifenesin HIV Infections Ritonavir Phenylephrine Sexually Transmitted Diseases Substance-Related Disorders Phenylpropanolamine Retroviridae Infections |
Respiratory System Agents Anti-Infective Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Infection Anti-Retroviral Agents Sensory System Agents Therapeutic Uses Analgesics Analgesics, Opioid RNA Virus Infections HIV Protease Inhibitors |
Anti-HIV Agents Immune System Diseases Central Nervous System Depressants Narcotics Enzyme Inhibitors Antiviral Agents Pharmacologic Actions Protease Inhibitors Lentivirus Infections Peripheral Nervous System Agents Antitussive Agents Central Nervous System Agents |