Project Focus HIV/AIDS; Primary HIV Infection; HIV treatment
Project Location Soweto, Johannesburg
Duration of Project 2005 – 2010
Project Partners Imperial College
Project Donors Wellcome Trust via Imperial College of Science, Technology & Medicine, UK
Contact Dr Sibongile Walaza
Project Aims /Objectives To determine the effect of two anti-HIV treatment schedules of limited duration in PHI on the rate of CD4 cell decline and, consequently, on the time to initiating long-term anti-HIV therapy.
Secondary Objective:To evaluate the effect of different durations of treatment during PHI on HIV-specific immune response and disease progression.
Project Activities It is planned to recruit 360 individuals internationally, (from sites in Australia, South Africa and the UK), over a period of 18 months. The duration of intervention at PHI is a maximum of 48 weeks, and all patients will be followed up for a minimum of 30 months, making a trial duration of 5 years.
Participants will be randomly allocated in a 1:1:1 ratio at trial entry to start one of the regimens of open treatment with:
- Arm A: Long course combination antiretroviral therapy (LCART) for 48 weeks
- Arm B: Short course combination antiretroviral therapy (SCART) for 12 weeks
- Arm C: No antiretroviral therapy
Anticipated/Actual Results To provide direct evidence for or against treating primary HIV infection with anti retrovirals .
The
primary efficacy endpoint will be the time from randomisation to reaching a CD4 of <350 cells/μl measured on two consecutive occasions not more than 4 weeks apart (not within first 3 months of trial entry).
The
secondary efficacy outcomes will include:
- HIV-specific CD4+ and CD8+ T-cell responses at week 60
- Slope of CD4 decline
- Time from randomisation to virological failure of first regimen of late treatment (LTX) or death
- Development of drug resistance not present at baseline, before starting LTX or at week 120 whichever is earlier
- Time from randomisation to the initiation of late treatment (LTX)
- Differences in blood pressure from randomisation at week 12 and week
Additional Outputs n/a
Future Plans Further research on early HIV treatment regimens