A global health controversy erupted this summer when the prominent scientific journal Nature ran an article entitled “HIV trial attacked.” Within, commentators squared off over whether a huge ongoing study provides suboptimal and thus unethical treatment options to mothers with HIV in the developing world.
The multinational PROMISE study (for Promoting Maternal and Infant Survival Everywhere) is enrolling thousands of pregnant women with HIV in hopes of comparing mortality and other clinical outcomes between mothers who receive lifelong HIV therapy to mothers who receive shorter treatment durations if they have less advanced HIV disease.
Changing HIV Treatment Guidelines
When first designed, the PROMISE study answered a critical question: Do HIV-infected mothers with intact immune systems need treatment after they deliver their babies? Yet subsequent changes to HIV treatment guidelines from the World Health Organization have made at least some global health experts reconsider whether the question can still be asked and answered.
Two years ago, the World Health Organization (WHO) recommended that all pregnant mothers with HIV receive lifelong HIV therapy. While this recommendation aligns with United States treatment guidelines, which urge lifelong HIV therapy for all adults, it is more aggressive than the approach in most developing world countries where HIV therapy is reserved for patients with advanced disease.
Since the PROMISE study includes short-term HIV treatments for some mothers with HIV, countries in the developing world that are scaling up to meet the new WHO guidelines are asking a logical question: Is it ethical to provide mothers with HIV in a research study therapies that are not recommended by the WHO or in newly revised national HIV treatment guidelines?
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.