Study Description

Overview

Official Title:  "HIV Infection and Breastfeeding: Interventions for Maternal and Infant Health"

Study Type:  Interventional

Study Design:  Prevention, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study

 

Primary Outcome Measures

  • Maternal weight loss between 4 weeks postpartum and 28 weeks
  • Infant HIV status at 28 weeks. (Infants found to have HIV at birth or 2 weeks after delivery will have been disenrolled.)
  • Exclusive breastfeeding and breastfeeding cessation by 28 weeks

Secondary Outcome Measures

  • Duration of exclusive breastfeeding
  • Infant HIV negative survival at 48 weeks
  • Maternal adherence to ARV, maternal CD4 count, and clinical assessment of opportunistic infection status through 48 weeks


Total enrollment:  2373

Study start date:  March 2004

Final randomization: February 2009

Primary completion date:  September 2009 (final data collection date for primary outcome measures)

Secondary completion date: January 2010 (final data collection date for secondary outcome measures)

Detailed Description

This study addresses the complex issues of HIV related maternal morbidity, mortality, and postnatal HIV transmission during breastfeeding and weaning in resource-poor countries. Objectives include assessment of mortality and morbidity among HIV-infected women; evaluation of interventions to reduce HIV transmission to infants exposed by breast milk; and assessment of early weaning as a risk-reduction strategy for infants of HIV-infected mothers.

The study will evaluate the following:

  • The efficacy of a high-density caloric/micronutrient nutritional supplement given to HIV-infected women who breastfeed in preventing maternal depletion (weight loss and micronutrient status).
  • The safety and efficacy of maternal or infant antiretroviral regimens, taken for up to 6 months during breastfeeding, in reducing infant HIV infection rates at 48 weeks.
  • The feasibility of exclusive breastfeeding for 6 months followed by rapid weaning.

Additional study objectives are to evaluate the feasibility of delivering these interventions in resource poor settings and to identify maternal, infant, and virologic factors associated with HIV transmission during breastfeeding.

Eligibility

Ages Eligible for Study: 14 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes

Inclusion Criteria

Recruitment and primary eligibility criteria

  • Age > 14 years
  • Ability to give informed assent or consent
  • Evidence of HIV infection, as documented by 2 positive ELISA antibody tests; or 1 positive ELISA, and 1 Western Blot; or 2 separate concurrent rapid tests
  • Currently pregnant (with a single or multiple fetuses)
  • Gestation < 30 weeks at referral from Call to Action Program
  • No serious current complications of pregnancy
  • Intention to breastfeed
  • Intention to deliver at the institution at which the study is based
  • Not previously enrolled in this study for an earlier pregnancy
  • Other than HIV, no active serious infection, such as tuberculosis or other potentially serious illnesses
  • No previous use of antiretrovirals including the HIVNET 012 regimen.
  • Mother's CD4 count > 250 cells/uL (> 200 cells/uL prior to July 24, 2006) determined in the antenatal clinic
  • Mother's ALT < 2.5 x ULN (upper limit of normal) determined in the antenatal clinic
  • Mother's Hgb > 7 gm/dl

Secondary eligibility criteria and treatment assignment

  • Mother who delivers outside of the institution at which the study is based must present with her infant to the study site within 36 hours of delivery
  • Mother accepts single-dose nevirapine and zidovudine+lamivudine 7-day regimen for herself and her infant
  • Infant birth weight > 2000 g
  • No severe congenital malformations or other condition(s) not compatible with life
  • Based on clinical assessment, no maternal condition which would preclude the start of the study intervention

 

Download full study protocol