906
Last Update Posted: 2021-11-04
Recruiting has ended
All Genders accepted | 18 Years + |
12 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients
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.
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
Relevant conditions:
HIV Infections
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov