FTC/RPV/TDF
DrugEmtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg single-tablet regimen (STR) administered orally with a meal once daily
Other names: Complera, Eviplera
NCT Number: NCT01286740
The purpose of this Phase 2b study was to evaluate the efficacy and safety of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) STR, after switching from the efavirenz (EFV)/FTC/TDF STR at baseline, in maintaining HIV-1 RNA < 50 copies/mL at Week 12. HIV-infected patients were enrolled if they had received EFV/FTC/TDF for ≥ 3 months prior to study start, were experiencing safety or tolerability concerns (in particular, EFV-related intolerance), and wished to change to an alternate, better-tolerated regimen.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Living Hope Clinical Foundation, Long Beach, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg single-tablet regimen (STR) administered orally with a meal once daily
Other names: Complera, Eviplera
Time frame: Week 12
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 12 was analyzed using the FDA snapshot analysis.
Time frame: Week 24
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the FDA snapshot analysis.
Time frame: Week 48
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA snapshot analysis.
Time frame: Week 1
The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 1.
Time frame: Week 2
The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 2.
Time frame: Week 4
The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 4.
Time frame: Week 6
The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 6.
Time frame: Week 8
The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 8.
Time frame: Week 12
The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 12.
Time frame: Week 12
The mean (SD) plasma concentration (ng/mL) of EFV was measured at Week 12. No analyses of EFV plasma concentrations were conducted after Week 12
Time frame: Week 24
The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 24.
Time frame: Week 36
The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 36.
Time frame: Week 48
The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 48.
Gilead Sciences
Industry
A Phase 2B Open Label Pilot Study to Evaluate Switching From a Regimen Consisting of a Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Single Tablet Regimen (STR) to Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) STR in Virologically Suppressed, HIV 1 Infected Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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