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DUT Collaborates in International HIV/AIDS Trial

DUT Collaborates in International HIV/AIDS Trial

A major international study – in which the Durban University of Technology was an academic partner – has found that HIV-infected individuals have a considerably lower risk of developing AIDS or other serious illnesses if they start taking antiretroviral drugs sooner when their CD4+ T-cell count – a key measure of immune system health – is higher instead of waiting until the CD4+ cell count drops to lower levels.

The new finding is from the Strategic Timing of AntiRetroviral Treatment (START) study, the first large-scale randomised clinical trial to establish that earlier antiretroviral treatment benefits all HIV-infected individuals.

The Durban University of Technology collaborated in the study through its research institute: Enhancing Care Foundation (ECF).

“For the first time, we have strong evidence from a study that included resource-constrained countries, that early treatment is beneficial to the HIV-positive person,” said Dr Sandy Pillay, Principal Investigator of the study at the Durban site. “This very significant finding will guide policy in developing countries all over the world.”

In total, the trial which opened in March 2011 was conducted in 215 sites in 35 developed and undeveloped countries and enrolled 4 685 HIV-infected men and women ages 18 and older. South Africa, which had four sites for the study, enrolled 518 participants – DUT’s Institute, ECF, was one of the highest enrolling sites internationally.

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, provided primary funding for the START trial. While the study was expected to conclude at the end of 2016, an interim review of the study data by an independent data and safety monitoring board (DSMB) recommended that results be released early.

Together with data from previous studies showing that antiretroviral treatment reduced the risk of HIV transmission to uninfected sexual partners, these findings support offering treatment to everyone with HIV. “We now have clear-cut proof that it is of significantly greater health benefit to an HIV-infected person to start antiretroviral therapy sooner rather than later,” said NIAID Director Anthony S. Fauci, M.D. “Moreover, early therapy conveys a double benefit, not only improving the health of individuals but at the same time, by lowering their viral load, reducing the risk they will transmit HIV to others. These findings have global implications for the treatment of HIV.”

The START study was conducted by the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT). Participants had never taken antiretroviral therapy and were enrolled with CD4+ cell counts in the normal range – above 500 cells per cubic millimeter (cells/mm3). Approximately half of the study participants were randomised to initiate antiretroviral treatment immediately (early treatment), and the other half were randomised to defer treatment until their CD4+ cell count declined to 350 cells/mm3. On average, participants in the study were followed for three years. Findings were consistent across geographic regions and the benefits of early treatment were similar for participants from low and middle-income countries and participants from high-income countries.

Prior to the START trial, there was no randomised controlled trial evidence to guide initiating treatment for individuals with higher CD4+ cell counts. Previous evidence to support early treatment among HIV-positive people with CD4+ cell counts above 350 was limited to data from non-randomized trials or observational cohort studies, and on expert opinion. Current World Health Organization HIV treatment guidelines recommend that HIV-infected individuals begin antiretroviral therapy when CD4+ cell counts fall to 500 cells/mm3 or less.

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