Completed

NCT Number: NCT03664440

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

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.

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Key information

Conditions

Efficacy of Rilpivirine-based Regimens as Switch Therapy

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University

Bangkok, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Recent plasma HIV-1 RNA viral load within 6 months of the screening that was less than 40 copies/mL, and a CD4 cell count that was more than 200 cells/mm3
Patient who treated with TDF/FTC/NVP or TDF/3TC/NVP for at least 6 month

Exclusion criteria

patients with a history of HIV drug resistance, patients who used other drugs or drugs which interact with RPV (proton pump inhibitors, histamine H2-receptor antagonists, rifampin, antiepileptic drugs), female patients during pregnancy or breastfeeding, patients whose estimated glomerular filtration rate (eGFR)was <60 mL/min/1.73m2 [by The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) (12)], and patients diagnosed with depressive or psychiatric disorders.

Treatment and study plan

Nevirapine

Drug

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.

Rilpivirine

Drug

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.

Primary outcomes

HIV RNA viral load

Time frame: week 48

HIV-1 RNA viral load was performed at 48 by using Amplicor HIV-1 Monitor Test version 1.5 (Roche, Basel, Switzerland)

Secondary outcomes

CD4 cell count

Time frame: week 48

blood for CD4 cell count was performed at week 48
CD4 percentage

Time frame: week 48

blood for CD4 percentage was performed at week 48
Change of total cholesterol

Time frame: baseline and week 48

Change from baseline of total cholesterol was performed at week 48
Change of high-density lipoprotein cholesterol level (HDL-c)

Time frame: baseline and week 48

Change from baseline of high-density lipoprotein cholesterol level (HDL-c) was performed at week 48
Change of low-density lipoprotein cholesterol level (LDL-c)

Time frame: baseline and week 48

Change from baseline of low-density lipoprotein cholesterol level (LDL-c) was performed at week 48
Change of triglyceride

Time frame: baseline and week 48

Change from baseline of triglyceride was performed at week 48

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Sep 10, 2018
Registry last updated: Sep 10, 2018

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.