About The Study
The purpose of this trial is to compare the antiviral efficacy of extended release nevirapine (NVP XR) 400 mg once daily in combination with xxx mg Truvada vs. nevirapine immediate release (NVP IR) 200 mg twice a day in combination with xxx mg Truvada in treatment-naïve HIV-1 infected people. This study will also be evaluating the safety and pharmacokinetics (how a drug is processed in the body) of NVP XR and NVP IR.
Participants will be randomly assigned to receive either nevirapine immediate release 200 mg twice daily and 1 tablet Truvada (200 mg Emtricitabine 300 mg Tenofovir) once daily OR nevirapine extended release 400 mg once daily and 1 tablet Truvada (200 mg Emtricitabine 300 mg Tenofovir) once daily.
This is a 48-week international study looking to recruit 50 participants in Canada.
Study Approach
Nevirapine is a type of anti-HIV drug called a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a “non-nuke.” NNRTIs are drugs that interfere with the growth of HIV in the body by holding back the HIV enzyme called “reverse transcriptase.” Nevirapine is approved for the treatment of HIV in Canada and is often used in combination therapy. The standard dosage of nevirapine for treatment-naïve people is one 200 mg tablet once daily for the first 14 days. Following the 14 days, the dosage is increased to one 200 mg tablet twice a day (Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. January 29 2008; 1-128. Available at: Healthcanada.ca (Accessed June 24 2008-page 19.) This study is testing a once a day 400 mg extended release nevirapine.
Truvada is the name of a fixed-dose co-formulation of two anti-HIV drugs: tenofovir (Viread) and FTC (emtricitabine, Emtriva) all in one pill. It is taken in combination with other anti-HIV drugs such as NNRTIs or protease inhibitors. (CATIE).
Study closed to enrolment.
Results
This trial is listed on Clinicaltrials.gov