CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28,153 enrolled
Drug / intervention
Immediate ARV treatment initiation with TDF/FTC/EFV +1 moredrug
Likely dose
Immediate ARV treatment initiation with TDF/FTC/EFV 245 mgfrom 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/NCT01509508
NCT01509508N/ACompleted
CompareCT.gov

A Cluster Randomised Trial Comparing the Impact of Immediate Versus South African Recommendations Guided ART Initiation on HIV Incidence. The ARNS 12249 TasP (Treatment as Prevention) Trial in Hlabisa Sub-district, KwaZulu-Natal, South Africa.

ANRS, Emerging Infectious Diseases·interventional·Posted Jan 13, 2012·Updated Apr 15, 2026

In Brief

A clinical study evaluating Immediate ARV treatment initiation with TDF/FTC/EFV and South African recommendation guided ARV (TDF/FTC/EFV) initiation for HIV Infection. Completed, enrolled 28,153 participants across 1 site.

Detailed Summary

This trial is evaluating a public health intervention strategy trial which aims to reduce the incidence of HIV at a population-level. The proposed strategy is a two steps process: * Extensive HIV counselling and testing, and comprehensive prevention programme among a target population * Immediate ART initiation after HIV diagnosis, irrespective of CD4 count criteria. The underlaying trial hypothesis is that HIV testing followed by immediate ART initiation of all HIV-infected individuals will prevent onward transmission and reduce HIV incidence in the population. This is a cluster randomised controlled trial with a total of 22 communities used as the units for randomisation. Enrolment of a population of 22 000 individuals among which 4 400 are expected to be HIV-Infected.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infection
CountriesSouth Africa
CollaboratorsAfrica Centre For Health and Population Studies, University of KwaZulu

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 13, 2012
Enrollment StartMar 1, 2012
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 14.5 years ago

Interventions

Immediate ARV treatment initiation with TDF/FTC/EFVdrug

All HIV-infected adults will be offered ART regardless of their immunological and clinical staging. The first line regimen proposed will be Atripla (R), a fixed dose combination containing tenofovir disoproxil (245 mg)/emtricitabine (200 mg)/efavirenz (600 mg)(FTC/TDF/EFV). The dosing will be 1 tablet OD.

South African recommendation guided ARV (TDF/FTC/EFV) initiationother

HIV-infected adult participants will be eligible for ART as per the South African guidelines (August 2011) if: * CD4 count ≤ 350 cells/mm3 irrespective of clinical symptoms * WHO clinical stage 3 or 4 irrespective of CD4 count * MDR or XDR TB The first line regimen proposed will be Atripla (R), a fixes dose combination containing tenofovir disoproxil (245 mg)/emtricitabine (200 mg)/efavirenz (600 mg)(TDF/FTC/EFV). The dosing will be 1 tablet OD.