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Optimal Combination Therapy after Nevirapine Exposure (OCTANE)  

The demonstration that single dose (SD) Nevirapine (NVP) could lead to a 50% reduction of MTCT (Mother to Child  Transmission) of HIV infection has resulted in a massive scale-up of prevention of mother to child transmission (PMTCT) programs, especially in resource limited countries.  The cost, safety, efficacy, simplicity and ease of administration of SD NVP to the mother and the baby have made this regimen popular in developing countries. The Kericho PMTCT program was started with assistance from WRP in August 2001 and to date has given SD NVP to 1,922 HIV- infected pregnant women and 1,297 infants. A potential downside of SD NVP for PMTCT of HIV-1 has risen following the observation of non-nucleoside reverse transcriptase inhibitor (NNRTI)-resistant viruses impose in the plasma of many women after SD NVP administration. The implications these NNRTI-resistant viruses in women who progress to need antiretroviral therapy (ART) later are unclear. The “Optimal Combination Therapy after Nevirapine Exposure” (OCTANE) Study aims to answer this question.  This phase III multi-center study will be conducted in 10 African sites and will consist of 2 randomized controlled clinical trials comparing the virologic response to NNRTI based and protease-inhibitor (PI) based antiretroviral treatment.  Trial 1 will evaluate the superiority of PI-based ART over NNRTI-based ART in women with prior single dose (SD) Nevirapine (NVP) prophylaxis for mother-to-child-transmission (MTCT) of HIV.  Trial 2 will evaluate the equivalence of PI- and NNRTI-based ART in women with no prior NVP exposure. The primary study drugs will include Nevirapine (Viramune®), lopinavir/ritonavir (Kaletra®), emtricitabine (Emtriva®) and tenofovir (Viread®). The primary end points will be time from randomization to virological failure or death. 

OCTANE is being implemented in 10 sites across the African continent. The study opened to accrual in October 25^th 2005 in South Africa and by the time Kericho started in May 2005, three other sites in Southern Africa were already recruiting.

As of 9 January 2007, Kericho site had recruited 37 participants.

OCTANE Team Members