About a pilot study of adherence of Lamivudine/Zidovudine+Efavirenz (3TC/ZDV+EFV) to treat HIV-1 infection in Senegal

Abstract

This is a prospective, open-label safety and efficacy trial of the initial antiretroviral therapy regimen 3TC/ZDV+EFV in Senegalese adults and adolescents. The trial will take place at two clinical sites in Dakar, Centre National Hospitalier de Fann and the Institut d'Hygiene Sociale (IHS). The Fann site serves a mixed population that includes adult and adolescent males and females. The IHS site serves primarily female commercial sex workers, a well-characterized high risk population that has been followed for >15 years. The primary efficacy end point is viral suppression to <200 copies mL-1 of HIV RNA by week 24. The safety end points include time to drug related treatment discontinuation and occurrence of a serious adverse event > Grade 3. Other evaluation parameters include change in CD4+count, characterization of genotypic resistance in those subjects who have experienced virologic failure by 24 and 96 weeks of treatment (HIV RNA >1000 copies mL-1 on 2 successive measurements within 30 days), levels of adherence, rate of disease progression, quality of life and agreement of proviral HIV-1 DNA vs. HIV-1 RNA measurements. Enrollment into the study is expected to occur over a 6 month accrual period. Adherence was consistently different by study site due to the fact that sites varied on the education and preparation given to patients who are on ART. Thus, researchers controlled for a main effect of site using a categorical covariate. The average CD4 percent for both groups was well above 14%, the criteria for AIDS. The average viral load (log) results were at or below the detectable ränge of <2.6 log10. © Medwell Journals, 2012.