PHASES: Pregnancy & HIV/AIDS: Seeking Equitable Study

Seeking ethical solutions to advance research at the intersection of women’s reproduction and HIV prevention, treatment, and management

Despite tremendous advances in science of prevention, treatment, and management of HIV since the emergence of the epidemic, we still know very little about how to best address the needs of a key population affected by HIV: pregnant women.

An estimated 17.8 million women are living with HIV worldwide, with millions more at risk of becoming infected.  Many of these women are of reproductive age, posing important medical questions about how best to prevent and treat HIV in pregnant women and how to properly manage HIV and concurrent medical conditions during pregnancy:


Pregnant women are up to two-times more likely to acquire HIV than other women, and infection during pregnancy has been demonstrated to increase the odds 15-fold of maternal- to-child transmission. Yet many prevention trials, including the groundbreaking CAPRISA 004 microbicide study, exclude pregnant women.

Treatment of Co-Infection

Studies have reported that HIV-infected pregnant women have active Tuberculosis (TB) at about 10 times the rate of HIV-uninfected pregnant women, and in South African teaching hospitals TB accounted for 15% of maternal mortality. However, many current TB regimens are not recommended during the first trimester of pregnancy (or for women with childbearing potential), and the emergence of drug-resistant TB presents further challenges. While a new class of antituberculosis drugs is revolutionizing the treatment of drug-resistant TB, pregnant women have been excluded from trials and there are no data to guide dosing or treatment decisions, even though drug-resistant TB associated with HIV is a major cause of perinatal morbidity and mortality.

Management of HIV

Studies of optimal dosing strategies for new antivirals in pregnant women have lagged behind the use of these new drugs in the clinical setting, meaning that pregnant women are being prescribed medication solely based on studies in non-pregnant individuals. This can lead to suboptimal or insufficient dosing with unknown associated toxicity.

For full information, visit the PHASES website.