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Ground-breaking HIV Study Results

Starting antiretroviral treatment early has substantial health benefits for those living with HIV.

The Desmond Tutu HIV Foundation (DTHF) Clinical Trials Unit has been a major participant in an important international clinical trial.  The results were released on 27th May and will have a considerable impact on the management of HIV treatment in the future. The study found that individuals who begin antiretroviral treatment at a CD4 count over 500/mm3 experience substantial health benefits over those who start treatment at a CD4 count less than 350/mm3.

The Strategic Timing of AntiRetroviral Treatment (START) study tested whether there was benefit to HIV+ patients in initiating antiretroviral treatment early. More than 4, 600 men and women living with HIV were enrolled at 215 sites in 35 countries. The study was conducted by the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT).

The DTHF Clinical Trials Unit enrolled 287 participants in the study, the largest number at any site.  The site also served as the Site Coordinating Centre for two other South African sites, Clinical HIV Research Unit in Johannesburg and the Durban International Clinical Research Site.  In total, South Africa enrolled 501 participants on the study.

Half of the study participants were randomised to start antiretroviral treatment immediately and the other half had their treatment treatment until their CD4+ cell count declined to less than 350 cells/mm3.  The study found that all patients had low levels of serious illness but those that initiated treatment earlier had a clear further benefit compared to those starting late. The rates of adverse events were similar in both groups indicating antiretroviral therapy was safe. The trial started in 2009 and was scheduled to close in December 2016, but a review by the study’s Independent Data and Safety Monitoring Board recommended that results be released early as the evidence was overwhelmingly in favour of early initiation of antiretroviral therapy.

“This is a very encouraging result which will inform policy  based on good quality data” said Prof. Robin Wood, Chief Executive Officer of the Desmond Tutu HIV Foundation and Principal Investigator for the site in Cape Town.   “We now have strong evidence that early treatment is beneficial to the HIV-positive person.”

In the light of these findings, all our participants are being informed of these results.   They will be offered treatment if they are not already on antiretroviral therapy and they will continue to be followed up on study until the end of 2016.

The Desmond Tutu HIV Foundation is a centre of excellence for HIV and TB research.  The Foundation is a not for profit organisation that has operated in association with the Faculty of Health Sciences, University of Cape Town since 2004.   We work in partnership with government health agencies and local and international partners to upscale and improve the management and treatment of HIV and TB and related infections.

Working from six sites and two mobile vehicles in under-resourced areas of Cape Town, community development and community support are integral to our research endeavours.

For more information see the NIH press release at:

http://www.niaid.nih.gov/news/newsreleases/2015/Pages/START.aspx#