Abstract

The proposed study would be a single-arm interventional trial in a community where HIV is endemic. The proposed observational design can provide confirmatory data for the initial clinical observation, data that would be necessary before considering whether a randomized controlled trial is appropriate. A previous ethical analysis has argued for conducting such a study in a country with limited resources and with higher HIV prevalence, and to recruit those with the highest risk of transmission. The primary rationale was to address the scientific question in the most efficient timeframe and to expose the smallest number of infants to the uncertain benefits and risks of the study. However, there are..