With regards to when to initiate antiretroviral therapy (ART), current guidelines are based largely on data from observational studies; some of these recommend initiating ART when the CD4+ cell count is ≤350 cells/mm3, while others recommend initiating ART when the CD4 cell count falls to <500 cells/mm3. While the potential for reducing morbidity and mortality with ART is great, current data available are insufficient and do not inform whether the benefits of initiating ART at CD4+ cell counts above 500 cells/mm3 outweigh the risks. It is critical to evaluate risks and benefits of early ART with a randomized trial.
The START (Strategic Timing of AntiRetroviral Treatment) Study is an international randomized trial to determine whether starting ART early (before CD4 drops to < 500 cells/mm³), rather than waiting until CD4 drops to > 350 cells/mm³ (when evidence from randomized trials supports starting ART), reduces the occurrence of serious morbidity and mortality. START began enrolment in April 2009 and is currently being carried out at 229 clinics in 35 countries around the world including Nigeria. Enrollment of the 4,600 participants needed is expected to finish in 2013, with follow-up ending in late 2016.
The Institute of Human Virology, Nigeria (IHVN) is anchoring this study in Nigeria. With two clinics (National Hospital, Abuja and University of Abuja Teaching Hospital, Abuja), IHVN is expected to contribute about 50 participants out of which 44 have been enrolled and on follow-up.Recruitment has been challenging and this is due to the very stringent inclusion criteria that include; ability to provide informed consent, documented HIV infection, age ≥ 18 years, Karnofsky performance score ≥ 80 (an indication that the participant can perform normal activities), perceived life expectancy of at least 6 months, for women of child-bearing potential, willingness to use contraceptives as described in the product information of the ART drugs they are prescribed, two CD4+ cell counts > 500 cells/mm3 at least 2 weeks apart within 60 days before randomization, and all participants must be ART-naïve (not taken ART before).
Although, in the recently released 2013 consolidated ART Guidelines, the World Health Organization now recommends ART initiation in adults with CD4 count of < 500 cells/mm³; the results from START study will provide scientific evidence to support this initiating ART at CD4 count of > 500 cells/mm³and to also understand the side effects, adherence challenges, and other problems that might occur with this expanded treatment approach.
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