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

NCT03664440 | Completed

• 1 other identifier: 10-59-04
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Efficacy of Rilpivirine-based Regimens as Switch Therapy

Keywords

rilpivirine switch therapy

Outcome Measures

Primary Outcomes (1)

• HIV RNA viral load

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

  week 48

Secondary Outcomes (6)

• CD4 cell count

  week 48

• CD4 percentage

  week 48

• Change of total cholesterol

  baseline and week 48

• Change of high-density lipoprotein cholesterol level (HDL-c)

  baseline and week 48

• Change of low-density lipoprotein cholesterol level (LDL-c)

  baseline and week 48

Study Arms (2)

continuation arm

PLACEBO COMPARATOR

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)

Drug: Nevirapine

switch arm

ACTIVE COMPARATOR

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 switch from NVP to RPV 25 mg once-daily plus TDF/3TC (group A2) and plus TDF/FTC (groupB2)

Drug: Rilpivirine

Interventions

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.

continuation arm

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.

switch arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

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

Bangkok, Thailand

Location

Related Publications (2)

• Hagins D, Orkin C, Daar ES, Mills A, Brinson C, DeJesus E, Post FA, Morales-Ramirez J, Thompson M, Osiyemi O, Rashbaum B, Stellbrink HJ, Martorell C, Liu H, Liu YP, Porter D, Collins SE, SenGupta D, Das M. Switching to coformulated rilpivirine (RPV), emtricitabine (FTC) and tenofovir alafenamide from either RPV, FTC and tenofovir disoproxil fumarate (TDF) or efavirenz, FTC and TDF: 96-week results from two randomized clinical trials. HIV Med. 2018 Nov;19(10):724-733. doi: 10.1111/hiv.12664. Epub 2018 Aug 12.

  PMID: 30101539 BACKGROUND

• Taramasso L, Tatarelli P, Ricci E, Madeddu G, Menzaghi B, Squillace N, De Socio GV, Martinelli C, Gulminetti R, Maggi P, Orofino G, Vichi F, Di Biagio A, Bonfanti P; CISAI Study Group. Improvement of lipid profile after switching from efavirenz or ritonavir-boosted protease inhibitors to rilpivirine or once-daily integrase inhibitors: results from a large observational cohort study (SCOLTA). BMC Infect Dis. 2018 Jul 31;18(1):357. doi: 10.1186/s12879-018-3268-5.

  PMID: 30064371 BACKGROUND

MeSH Terms

Interventions

Nevirapine; Rilpivirine

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nitriles; Organic Chemicals; Pyrimidines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: September 10, 2018
• Study Start: December 1, 2016
• Primary Completion: October 31, 2017
• Study Completion: October 31, 2017
• Last Updated: September 10, 2018

Record last verified: 2018-09

Locations

TH (1)