Evaluating Strategies to Reduce Mother-to-Child Transmission of HIV Infection in Resource-Limited Countries

Summary

The purpose of this study was to examine, in an integrated and comprehensive fashion, three critical questions currently facing HIV-infected pregnant and postpartum women and their infants:

1. What is the optimal intervention for the prevention of antepartum and intrapartum transmission of HIV?
2. What is the optimal intervention for the prevention of postpartum transmission in breastfeeding (BF) infants?
3. What is the optimal intervention for the preservation of maternal health after the risk period for prevention of mother-to-child-transmission ends (either at delivery or cessation of BF)?

The overall PROMISE protocol had three separate interventional components to address each of these three questions and was conducted at locations in Africa and other parts of the world. Due to variations in the standard of care for HIV-infected pregnant and postpartum women and their infants at different sites, not all of these questions were relevant. Therefore, two separate versions of the PROMISE protocol were developed, each containing only the relevant components. The 1077BF protocol was used at sites where the standard method of infant feeding was breastfeeding, whereas the 1077FF protocol was used at sites where the standard method of infant feeding was formula feeding. The analyses were collapsed across the two protocol versions, and therefore the summaries contain the results of the 1077BF and/or the 1077FF protocols.

Conditions

• HIV Infections

Interventions

DRUG

Zidovudine (ZDV)

300 mg twice daily

DRUG

Nevirapine (NVP): Antepartum Mothers

200 mg at onset of labor

DRUG

Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]) tail

200 mg/300 mg x 2 tablets at onset of labor or as soon as possible thereafter; 200 mg/300 mg orally each day after delivery for 7 days or the date of the Week 1 visit (up to 14 days), whichever is later.

DRUG

Lamivudine-Zidovudine (3TC-ZDV)

150 mg/300 mg twice daily

DRUG

Lopinavir-ritonavir (LPV-RTV)

400 mg/100 mg twice daily beginning at \>= 14 weeks gestation; 600 mg/150 mg twice daily beginning at \>= 28 weeks gestation or at next visit (during third trimester) through delivery; 400 mg/100 mg twice daily after delivery up to 14 days postpartum.

DRUG

Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV])

200 mg/300 mg

DRUG

Nevirapine (NVP): Infant short-course

Oral suspension (dosing according to birth weight) once a day through 42 days of age or through the week 6 visit, whichever is later.

DRUG

Nevirapine (NVP): Infant extended

Oral suspension (dosing according to birth weight) once a day from 6 (up to 14) days of age until there was no longer any risk of MTCT or until the end of follow-up (104 weeks), whichever came first.

OTHER

No Intervention

Women registered before/during labor received the full Antepartum Arm A regimen. Women registered after labor, and who received nevirapine outside of the study, received the Emtricitabine-tenofovir disoproxil fumarate (Truvada \[TRV\]) tail.

OTHER

Discontinue triple ARVs

ARVs were discontinued. When protocol specified criteria were met, mothers could be prescribed any licensed antiretroviral medication, as long as the treatment met the definition of HAART (three ARV drugs from two or more drug classes).

OTHER

Continue triple ARVs

Mothers could be prescribed any licensed antiretroviral medication, as long as the treatment met the definition of HAART (three ARV drugs from two or more drug classes).

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Mary Glenn Fowler, MD, MPH · Johns Hopkins Medical Institute, Makerere U.-JHU Research Collaboration

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-03-01

Primary Completion

2016-09-30

Completion

2016-09-30

Countries

• India
• Malawi
• South Africa
• Tanzania
• Uganda
• Zambia
• Zimbabwe

Study Locations