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Anti-Retroviral Agents clinical trials

View clinical trials related to Anti-Retroviral Agents.

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NCT ID: NCT03279120 Completed - Contraceptive Usage Clinical Trials

Safety, PK, and PD Study of IVRs Releasing TFV and LNG

TFV/LNG IVR
Start date: September 28, 2017
Phase: Phase 1
Study type: Interventional

This multi-center Phase I study is designed to characterize the safety, PK, and PD of TFV/LNG IVR to assess systemic and genital tract bioavailability in healthy women. The IVRs to be used in the study are TFV/LNG IVR (8-10mg per day/20μg per day) or placebo IVR. Samples will be obtained before, during and after 90 days of continuous or interrupted IVR use.

NCT ID: NCT03251690 Completed - Dyslipidemias Clinical Trials

Switching TDF/FTC/EFV to TDF/FTC/RPV VS Continuing TDF/FTC/EFV in HIV Patients With Complete Virological Suppression

STEREOS
Start date: October 27, 2016
Phase: N/A
Study type: Interventional

According to the Thai National Guidelines for Treatment of HIV/AIDS 2014, the recommended first line ART regimen was 2 NRTIs backbone, TDF and FTC; plus 1 NNRTI, EFV, with RPV as an alternative one. Most of the randomized-controlled studies, including ECHO and THRIVE, showed the non-inferiority of RPV compared with EFV in naive cases. But there were not much randomized-controlled trials for changing from other NRTI to RPV in patients who currently on another ART, especially in Thailand. Moreover, the concerned adverse effects of dyslipidemia and neurological symptoms were better in RPV-based than EFV-based regimen. Finally, the cost-effectiveness and universal coverage are also the benefit of RPV over EFV in term of economics.

NCT ID: NCT00412646 Completed - HIV-1 Clinical Trials

TMC125-C203: Phase II Randomized (Patients Are Assigned Different Treatments Based on Chance), Placebo Controlled Dose Escalating Trial of TMC125 in HIV-1 Infected Patients

Start date: June 2002
Phase: Phase 2
Study type: Interventional

The purpose of this randomized (patients are assigned different treatments based on chance), placebo-controlled, dose-escalating trial is to evaluate the safety, tolerability and efficacy of different doses of TMC125 twice daily ( b.i.d.) when added to an individually optimized antiretroviral therapy (ART) for 48 weeks. Dose-escalation will be performed in two stages. In the first stage approximately one hundred and eighty HIV-1 positive, three-class ART experienced patients will be randomized to placebo, 400 or 800 mg of TMC125 b.i.d. In the second stage, approximately seventy patients will be randomized to placebo, 800 or 1200 mg TMC125 b.i.d. Stage 2 will be opened for enrollment after review of the available safety and efficacy data for a specified number of patients and concurrence by the Data Safety and Monitoring Board (DSMB). After all patients are treated for a period of 12 weeks, unblinding for the sponsor will occur. The trial will continue in a single-blind fashion (sponsor unblinded, but investigator and patient blinded) for up to 48 weeks. Upon completion of the initial 48 weeks of treatment, patients deriving clinical benefit, in the opinion of the investigator, will have the option to prolong the same treatment, in a single-blind setting up to a maximum of 144 weeks.