CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 426 enrolled
Drug / intervention
Rilpivirine +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01709084
NCT01709084Phase 3Completed
CompareCT.gov

A Phase 3b, Randomized, Open-label Clinical Study to Demonstrate Non-inferiority in Virologic Response Rates of HIV-1 RNA Suppression <400 Copies/mL of TDF/FTC/RPV Versus TDF/FTC/EFV in First-line Antiretroviral NNRTI-based Suppressed Patients. Switching At Low HIV-1 RNA Into Fixed Dose Combinations (SALIF)

Janssen-Cilag International NV·interventional·Posted Oct 17, 2012·Updated Feb 11, 2021

In Brief

A Phase 3 clinical trial evaluating Rilpivirine, Efavirenz, and 2 other interventions for Human Immunodeficiency Virus-type 1 Infection. Completed, enrolled 426 participants across 18 sites in 6 countries.

Detailed Summary

The purpose of this study is to demonstrate noninferiority (a new treatment is equivalent to standard treatment) in terms of the percentage of patients who have plasma human immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) levels less than 400 copies per mL after 48 weeks of randomized treatment with tenofovir disoproxil fumarate/emtricitabine/rilpivirine (TDF/FTC/RPV) versus TDF/FTC/efavirenz (TDF/FTC/EFV).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHuman Immunodeficiency Virus-type 1 Infection
CountriesCameroon, Kenya, Senegal, South Africa, Thailand, Uganda
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 17, 2012
Enrollment StartOct 2, 2013
Primary CompletionOct 22, 2015
Study CompletionJul 2, 2020
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 13.7 years ago

Interventions

Rilpivirinedrug

Type=exact number, unit=mg, number=25, form=tablet, route=oral. Rilpivirine will be administered in a fixed dose combination along with tenofovir disoproxil fumarate and emtricitabine, as a single dose tablet.

Efavirenzdrug

Type=exact number, unit=mg, number=600, form=tablet, route=oral. Efavirenz will be administered in a fixed dose combination along with tenofovir disoproxil fumarate and emtricitabine, as a single dose tablet.

Tenofovir disoproxil fumaratedrug

Type=exact number, unit=mg, number=300, form=tablet, route=oral. Tenofovir disoproxil fumarate will be administered in a fixed dose combination along with rilpivirine and emtricitabine in Group 1, and along with efavirenz and emtricitabine in Group 2.

Emtricitabinedrug

Type=exact number, unit=mg, number=200, form=tablet, route=oral. Emtricitabine will be administered in a fixed dose combination along with rilpivirine and tenofovir disoproxil fumarate in Group 1, and along with efavirenz and tenofovir disoproxil fumarate in Group 2.