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 U=U
Study Design:Open label, Randomized
Arms and Assigned Interventions
DescriptionDrug: 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 DeliveryTablet
ARMsExperimental
DescriptionOther: 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 DeliveryTablet
ARMsExperimental
Official Code:
Impact of Immediate Versus South African Recommendations Guided ART Initiation on HIV Incidence (TasP) (https://clinicaltrials.gov/ct2/show/NCT01509508)
Start Date
End Date
December 20, 2011
December 20, 2016
Enrollment:22,000
Age range:
16 Years ↔
any
Population:Cisgender Men, Cisgender Women