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Switch From Nevirapine-based Regimen to Once a Day Rilpivirine/Emtricitabine/Tenofovir

NCT02104700 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-03-17

No results posted yet for this study

Summary

The study will be an open-label, pilot study in virologically suppressed patients comparing the efficacy, safety and tolerability of two Antiretroviral regimen strategies:

Arm A: "Immediate switch" Rilpivirine/Emtricitabine/Tenofovir (single tablet formulation (STF))at randomization

Arm B: "Delayed switch" Continue Nevirapine/Lamivudine/other Nucleoside reverse transcriptase inhibitor (NRTI)through 24 weeks then switch to STF of Rilpivirine/emtrictabine/tenofovir and followed through 48 weeks.

Conditions

Interventions

DRUG

Rilpivirine/Emtricitabine/Tenofovir

Rilpivirine 25mg/Emtricitiabine 200mg/Tenofovir 300mg FDC qday

Sponsors & Collaborators

Principal Investigators

  • Andrew Zolopa, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-05-31
Completion
2016-07-31

Countries

  • Rwanda

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02104700 on ClinicalTrials.gov