International Maternal Pediatric Adolescent AIDS Clinical International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPACT) Group Trials (IMPACT) Group

PROMISE (BREAST FEEDING) 1077PROMISE (BREAST FEEDING) 1077

AAHU STC 2013 Group 2 AAHU STC 2013 Group 2 Cedric Sturdevant, Tanya Henderson, Damone Cedric Sturdevant, Tanya Henderson, Damone

Thomas, and Juan PierceThomas, and Juan Pierce

August 12, 2013August 12, 2013

IMPAACTIMPAACT

• 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 PROGRESSSTUDIES 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 STUDIESPENDING 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 What’s the Strategy Promise 1077BFPromise 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?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+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 What we know from other studiesother 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 fromWhat we know from other studies other studies

• Some other studies have not shown that continuing H.AART is better than stopping

What are we trying to learnWhat 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 StudyOther 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 StudyOther 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 StudyOther 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 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.