Publication:

Excellent retention, virologic and clinical outcomes after transitioning from an antiretroviral treatment clinical trial to locally-provided care and treatment in Africa

Background Little is known about outcomes among clinical trial participants following completion of study-provided care and treatment in resource limited settings. We sought to describe outcomes among HIV clinical trial participants after transitioning to local routine care in Africa.

Methods In the OCTANE study, 741 women with CD4 <200 cells/mm3 in 7 African countries were randomized to initiate antiretroviral treatment (ART) with tenofovir/emtricitabine (TDF/FTC) plus either lopinavir/ritonavir (LPV/r) or nevirapine (NVP). When study-specified ART ended (48-191 weeks after study entry), participants transitioned to locally-provided HIV care and non-study ART. Consenting participants were interviewed and had toxicity labs, CD4 and HIV-1 RNA testing, and clinical outcomes assessed at 12 and 72 weeks after transition to local care.

Results Five hundred thirteen (77%) of the 669 women in follow-up at completion of the interventional trial participate in the extended follow-up. 513 women, 476 (93%) had HIV-1 RNA <400 cp/mL at time of transition, and 489 (95%) completed follow-up.  Seventy-seven women (19%) had a total of 99 antiretroviral regimen changes during post-trial follow-up. 30% of the 99 regimen changes-were due to lack of local drug availability. Thirteen (3%) women had Grade ≥3 laboratory abnormalities and 3 experienced worsening of the WHO HIV stage. Two women died. Eighty-nine percent of 484 with results had HIV-1 RNA ≤400 cp/mL at 72 weeks after transition to local non-study HIV care and treatment.

Conclusions The vast majority of women were able to continue key components of their ART and to maintain virologic suppression through 72 weeks of locally-provided post-study care.Trial registration: ClinicalTrials.gov NCT00089505