NCT03664440

Efficacy of Rilpivirine-based Regimens as Switch Therapy From Nevirapine-based Regimens in HIV-infected Patients

Efficacy of Rilpivirine-based Regimens as Switch Therapy From Nevirapine-based Regimens in HIV-infected Patients With Complete Virological Suppression: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

Background: Nevirapine (NVP)-based antiretroviral therapy (ART) remains to be used in HIV-infected patients in resource limited countries despite its compliance and adverse effect concerns. Rilpivirine (RPV), a newer non-nucleoside reverse transcriptase inhibitor, could be used as an alternative to NVP in virologically suppressed patients. However, there has been limited experience with switching from NVP-based to RPV-based regimens. The investigators aimed to study efficacy and adverse events after ART switching from NVP-based to RPV-based regimens. Methods: A randomized controlled non-inferiority trial was conducted in HIV-infected patients who received NVP-based regimens and had undetectable plasma HIV RNA for more than 6 months. Patients were randomized 1:1 to continuation arm (NVP-based regimens were continued) or switch arm (NVP-based regimens were switched to RPV-based regimens). Tenofovir disoproxil fumarate (TDF) plus lamivudine (3TC) or emtricitabine (FTC) remained as the backbone of the regimens. Primary endpoint was HIV RNA \<40 copies/mL at 48 weeks, with a non-inferiority margin of 12%. Changes of CD4 cell counts and lipid profiles from baseline were analyzed.

Detailed description

A single-center randomized controlled, non-inferiority trial to study 48-week treatment outcomes of RPV as a switch therapy was conducted at Ramathibodi Hospital, a tertiary care health center in Thailand from December 2016 to October 2017 Eligible patients who currently received TDF/3TC/NVP (group A) or TDF/FTC/NVP (group B) were block 4 randomly assigned (1:1) by computer-generated random numbers, to continue their current regimen of NVP 200 mg twice daily plus TDF/3TC (group A1) and plus TDF/FTC (groupB1), or to switch from NVP to RPV 25 mg once-daily plus TDF/3TC (group A2) and plus TDF/FTC (groupB2). Patients were advised to take RPV with a meal. Patients were scheduled trial visits at baseline, week 12, 24, 36 and week 48. The laboratory assessment was performed at baseline week 24 and week 48.

Conditions

• Efficacy of Rilpivirine-based Regimens as Switch Therapy

Interventions

Type	Name	Description
DRUG	Nevirapine	Patients were randomized 1:1 to continuation arm (NVP-based regimens). Tenofovir disoproxil fumarate (TDF) plus lamivudine (3TC) or emtricitabine (FTC) remained as the backbone of the regimens.
DRUG	Rilpivirine	Patients were randomized 1:1 to switch arm (NVP-based regimens were switched to RPV-based regimens). Tenofovir disoproxil fumarate (TDF) plus lamivudine (3TC) or emtricitabine (FTC) remained as the backbone of the regimens.

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-10-31
• Completion: 2017-10-31
• First posted: 2018-09-10
• Last updated: 2018-09-10

Locations

1 site across 1 country: Thailand