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Impact of Immediate Versus South African Recommendations Guided ART Initiation on HIV Incidence (TasP)

Status
Ongoing
Phase
Open Label
Principal Investigator(s)
François Dabis, Marie-Louise Newell, Deenan Pillay
Objective

This trial is evaluating a public health intervention strategy trial which aims to reduce the incidence of HIV at a population-level.

Prevention Option(s)
Treatment
Study Design
Randomized
Open label
Arms and Assigned Interventions
Description
Drug: Immediate ARV treatment initiation with TDF/FTC/EFV 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.
Mode of Delivery
Tablet
Products
TDF/FTC (Truvada)
ARMs
Experimental
Description
Other: South African recommendation guided ARV (TDF/FTC/EFV) initiation 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.
Mode of Delivery
Tablet
Products
TDF/FTC (Truvada)
ARMs
Experimental
December 2011
December 2016
Enrollment
22 000
16
Years
Population
Women
Men
Sites

Hlabisa CRS

KwaZulu-Natal
South Africa