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The OCTANE (Optimal Combination Therapy After Nevirapine Exposure) Study will soon begin recruiting participants in Botswana. The trial, which is funded by the Division of AIDS at the U.S. NIH and being conducted with assistance from the U.S. Adult Aids Clinical Trials Group (AACTG), is a multi-site study that will take place in 10 sites in 7 African countries: Botswana, Kenya, Malawi, South Africa, Uganda, Zambia and Zimbabwe.
The purpose of this study is to determine whether women starting antiretroviral treatment (ART) will have a better response to a regimen containing nevirapine (NVP) versus a regimen containing a protease inhibitor (PI). The question is relevant in Botswana because at least 20% of women who take single-dose nevirapine (sd-NVP) -- a component of the national program for the prevention of mother-to-child transmission of HIV (PMTCT)-- develop resistance to NVP. The clinical significance of this NVP resistance is not known, but it could potentially have a negative impact on a woman’s response to NVP-containing ART if she subsequently starts ART for her own health. The study will be conducted among 640 women with CD4 counts < 200 cells/mm3 (240 women with and 400 women without prior exposure to sd-NVP), with approximately 60-70 women enrolled per site. BHP will conduct the study at the Mashi Study sites located in Gaborone and Molepolole. Study participants will be followed for 48 weeks after the last participant has been enrolled.
The OCTANE Study is the first large-scale randomized trial comparing ART regimens conducted exclusively among women. The overall study is being led by Dr. Shahin Lockman and will be locally coordinated by Dr. Carolyn Wester.
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