International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPACT) Group PROMISE (BREAST FEEDING) 1077 AAHU STC 2013 Group 2 Cedric Sturdevant, Tanya Henderson, Damone Thomas, and Juan Pierce August 12, 2013

IMPAACT Cooperative Group of institutions, investigators, and other collaborators organized for the purpose of evaluating potential therapies for HIV infection and its sequelae in the infant, pediatric, adolescent and pregnant women populations.

STUDIES IN PROGRESS STUDIES IN PROGRESS There are approximately 20 studies open to accrual The scientific committees include: HIV Prevention 4 studies HIV Treatment 5 studies Complications 6 studies Vaccines 3 studies TB 2 studies

PENDING STUDIES There are approximately 8 pending studies The scientific committees include: TB 2 studies HIV Treatment 4 studies HIV Prevention 1 study Complications 1 study

What’s the Strategy Promise 1077BF A randomized strategy trial conducted among women who received highly active antiretroviral therapy (HAART) during pregnancy for purposes of prevention of mother-to-child transmission (PMTCT) of HIV but do not otherwise meet criteria to initiate HAART for their own health.

What has been done? In women with HIV who become pregnant are given a combination of HIV medicines (HAART) to try to keep their babies from getting HIV. When these women are no longer pregnant, a decision must be made to either continue taking HAART or to stop taking HAART. For women with high CD4+ cell counts (counts of cells that fight HIV), HAART is usually stopped after pregnancy.

Why use this strategy+ However, it is not known if it is better for women to stop or continue taking HAART after pregnancy. The main purpose of this study is to answer that question.

What we know from other studies Some studies in nonpregnant people have shown that it is better to continue taking HAART once started, rather than stopping, but people in these studies often had much lower CD4+ cell counts and had been on HAART longer than women who take it only during pregnancy.

What we know from other studies Some other studies have not shown that continuing H.AART is better than stopping

What are we trying to learn If stopping HAART is better, worse, or the same in the long run compared to continuing HAART, in this study we will see how women who stop HAART after pregnancy do compared to women who continue taking HAART after pregnancy.

Other Goals of Study To see how well the women will be able to take HAART after pregnancy and how that relates to remaining healthy and having a low amount of the HIV in blood. To see if one or a combination of blood tests that measure how the immune system (the system that fights infections) is affected by stopping or continuing HAART after pregnancy.

Other Goals of Study To see if there are differences in the number of illnesses (for example, infections, heart disease, kidney disease, liver disease), and abnormal blood tests in women who stop HAART compared to women who continue HAART after pregnancy

Other Goals of Study To see if there are differences in the chances of developing resistance to HIV medicines in women who stop HAART compared to women who continue HAART after pregnancy.

Other Goals of the Study To see if there are differences in quality of life and costs of health care in women who stop HAART compared to women who continue HAART after pregnancy.