Plugging Hair ARV Levels as Adherence Biomarkers into HIV Prevention Trials

Investigator: Monica Gandhi, MD, MPH
Sponsor: NIH National Institute of Allergy and Infectious Disease

Location(s): Malawi; Uganda; Tanzania; Zambia; Zimbabwe; South Africa; India


We hypothesize that ARV adherence assessed by hair concentrations of drug in HIV prevention trials will predict protection from HIV acquisition and toxicities more accurately than “traditional” measures of adherence such as self report and product return counts. We further hypothesize that determining thresholds for ARV exposure in hair associated with a low risk of HIV acquisition and developing low cost methods of measuring ARVs in hair will allow for the implementation of simple standard protocols for assessing adherence in HIV prevention trials and roll-out programs. Population: We propose to collect hair specimens for measurement of nevirapine (NVP) concentrations in infants and lopinavir-ritonavir (LPV-RTV) levels in mothers and infants over the duration of breastfeeding in postpartum Arm B (infant regimen) and postpartum Arm A (maternal regimen), of the PROMISE study(Promoting Maternal-Infant Survival Everywhere). Started in 2010, the study has enrolled more than 3500 HIV-infected pregnant or post-partum women in India, Malawi, South Africa, Tanzania, Uganda, Zambia and Zimbabwe.