Background: Little is known about outcomes among clinical trial participants following completion of studyprovided
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 nonstudy
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