Compliance with antiretroviral regimens to prevent perinatal HIV-1 transmission in Kenya

OBJECTIVE: To compare compliance and infant HIV-1 infection risk at 6 weeks with the Thai-CDC and HIVNET-012 antiretroviral regimens in a field setting. DESIGN: Randomized clinical trial. SETTING: Tertiary hospital antenatal clinic in Nairobi, Kenya. PARTICIPANTS: HIV-1 infected women referred from primary care clinics. INTERVENTIONS: Thai-CDC zidovudine regimen or HIVNET-012 nevirapine regimen. MAIN OUTCOME MEASURES: Women were considered compliant if they used >or= 80% of the doses. Infants were tested for HIV-1 at 6 weeks. RESULTS Seventy women were randomized to Thai-CDC and 69 to HIVNET-012 regimens. More women were compliant with the antenatal (86%) than the intrapartum (44%) Thai-CDC regimen doses ( P= 0.001). Ninety-seven per cent took the maternal and 91% gave the infant dose of the HIVNET-012 regimen (P = 0.2). Overall, 41% were compliant with the Thai-CDC regimen and 87% with the HIVNET-012 regimen ( P< 0.001). Compliance with the Thai-CDC regimen was associated with partner support of antiretroviral use odds ratio (OR), 3.0;, 95% confidence interval (CI), 1.0-9.1 and knowledge at recruitment that antiretroviral drugs could prevent infant HIV-1 (OR, 2.9; 95% CI, 1.0-8.1). Compliance with the HIVNET-012 regimen was associated with partner notification (OR, 8.0; 95% CI, 1.5-50) and partner willingness to have HIV-1 testing (OR, 7.5; 95% CI, 1.4-40). There was a trend for a higher risk of transmission with the HIVNET-012 regimen than with the Thai-CDC regimen (22% versus 9%; P= 0.07). CONCLUSION: Compliance with the Thai-CDC and HIVNET-012 regimens was comparable to that in efficacy trials. Partner involvement, support and education on perinatal HIV-1 prevention may improve compliance and increase the number of infants protected from HIV-1 infection.