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Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients Clinical research trials and Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients. Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients clinical trial. Test subjects typically receive the most expert healthcare available for their Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients  Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients
Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Dose Comparison, Bio-availability Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 12
Location and Contact Information:
Overall Study Official:
JohnGerber, Study Chair,
Beth Israel Med Ctr
New York City, New York, 10003
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Chelsea Ctr
New York City, New York, 10021
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Additional Information:
Study ID Numbers: ACTG 401;
Study Start Date: January 1998
Record last reviewed: October 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000906
Other Hiv Infections Studies:
1. A Phase I Study to Evaluate the Safety and Toxicity of the Combination of Zidovudine and 2',3'-Dideoxyinosine (Didanosine) in Children With HIV Infection
2. New Tablet Containing Two FDA Approved Anti-HIV Drugs For Antiretroviral Therapy Experienced HIV-1 Infected Subjects
3. A Phase I Concentration-Targeted Multidose Study of Atevirdine Mesylate ( U-87201E ), AZT, and ddI or ddC
4. Daily Tenofovir DF to Prevent HIV Infection Among Sex Workers in Cambodia
5. Phase II Study of Novantrone(R) (Mitoxantrone) and Etoposide in Patients with HIV Associated Large Cell and Immunoblastic Lymphomas
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients
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