HAART Standard Version of the PROMISE Study

(Promoting Maternal and Infant Survival Everywhere)

A randomized trial that will screen and recruit pregnant or postpartum women on HIV medications for prevention of mother-to-child transmission of HIV. The study will see if it is better for the health of the woman if she continues HIV medications or stops after delivery as is currently done.

Eligible participants will be randomized within 28 days postpartum to one of two study arms:

• Arm A=Continuing HIV meds postpartum
• Arm B=Stopping HIV meds postpartum; but will be returned to HIV meds if she medically needs them.

Women will be followed until 84 weeks after the last woman is enters the study; which could be up to 5.75 years total.

• In order to participate you must:

  • Be HIV positive
  • Be pregnant or within 28 days of delivery
  • Have taken at least four weeks of HIV meds prior to delivery
  • Have only taken HIV meds while pregnant or have taken less than 14 days of HIV meds when not pregnant
  • Have CD4 cell count greater than or equal to 400 cells

  You will not be able to be in the study if you:

  • Participated in the PROMISE (P1077) study
  • Had tuberculosis (TB) treatment within 30 days
  • Have a medical need for HIV meds other than because you are pregnant
  • Plan to breast feed
  • Have hepatitis B infection with a viral level over 2000 along with abnormal liver test results (ALT)