Evaluating Strategies to Reduce Mother-to-Child Transmission of HIV Infection in Populations Using Formula Feeding (PROMISE) — PROMISE  

HIV Clinical Trial

Official title: Formula Feeding Version of the PROMISE Study (Promoting Maternal and Infant Survival Everywhere)

Status Completed

Clinical Trial Summary

The purpose of this study is to examine effective methods of preventing the transmission of HIV from mother to child during pregnancy, labor, and delivery. This is one part of the three-part PROMISE study. This study will be conducted at resource-limited locations in Africa and other parts of the world where women typically receive a short course of highly active antiretroviral therapy (HAART) during pregnancy and where formula feeding (FF) is standard.

Clinical Trial Description

The incidence of mother-to-child transmission of HIV has decreased in recent years in the United States, Europe, and other resource-advantaged countries. Several factors have contributed to this decrease, including the administration of HAART during pregnancy, caesarean section delivery methods, and the use of formula instead of breastfeeding to feed infants. However, these improvements have mostly been seen in the United States, Europe, and other resource-advantaged areas. In resource-limited countries, barriers to the implementation of effective interventions for the prevention of mother-to-child transmission (PMTCT) still remain.

The PROMISE study is evaluating effective methods of preventing the transmission of HIV from a mother to her baby during pregnancy, labor and delivery, and breastfeeding. This version of the PROMISE study will be conducted at research sites in Africa and other parts of the world where formula feeding is standard.

This study is divided into two parts:

1. Antepartum Component:

This part of the study will compare the safety and effectiveness of different HAART regimens at preventing the transmission of HIV during pregnancy, labor, and delivery.

Pregnant HIV-infected women will be randomly assigned to one of the following three groups:

Arm A: Participants will receive zidovudine (ZDV) + single dose nevirapine (sdNVP) + emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]) tail. Participants will receive ZDV from 14 weeks gestation through delivery, sdNVP and TRV at onset of labor, and TRV postpartum for 7 days or through the Week 1 visit (6-14 days postpartum), whichever is later.

Arm B: Participants will receive lamivudine (3TC)-zidovudine (ZDV) + lopinavir (LPV)-ritonavir (RTV). Participants will receive the triple antiretroviral (ARV) study drug regimen from 14 weeks gestation through the Week 1 visit (6-14 days postpartum).

Arm C: Participants will receive TRV/LPV-RTV. Participants will receive the triple ARV study drug regimen from 14 weeks gestation through the Week 1 visit (6-14 days postpartum).

Fixed-dose FTC-TDF-RPV (Complera) may be used as an alternative first-line regimen for mothers who are not able to tolerate or adhere to LPV-RTV or ATV-RTV. The FTC-TDF-RPV regimen is not defined in the protocol and should be determined at the discretion of staff at the study sites.

All infants born to women enrolled in this study will receive NVP once a day through 42 days of age or until the Week 6 study visit, whichever is later, regardless of which study arm their mother is enrolled in. Should women need HAART or to switch HAART regimens for their own health, they will be moved into Step 2 or Step 3 of this part of the study.

During pregnancy, participants will attend study visits at study entry, 2 and 4 weeks after entry, and then every 4 weeks until labor and delivery. Women and infants will be monitored during labor and delivery and will attend a study visit 6 to 14 days after delivery. Follow-up visits will occur at Weeks 1, 6, and 14. Thereafter, they will be once a month for infants and every 3 months for women. Study visits may include a medical history review, questionnaires, interviews, physical exam, and blood collection.

2. Maternal Health Component:

This part of the study will examine if women who received a triple ARV regimen during pregnancy have better health outcomes than women who discontinue a triple ARV regimen.

Participants will include women who were receiving the triple ARV regimen in the Antepartum Component.

Participants will be randomly assigned to one of two study arms:

Arm A: Participants will continue to receive the triple ARV regimen (TRV and LPV-RTV).

Arm B: Participants will discontinue the triple ARV regimen.

Study visits will occur at Weeks 4 and 12, then every 3 months thereafter. Women who are infected with hepatitis B virus (HBV) will have an additional visit at Week 8. Study visits may include a medical history review, questionnaires, physical exam, and blood collection. Should women need a triple ARV regimen or to switch triple ARV regimens for their own health, they will be moved into Step 2 or Step 3 of this part of the study.

The total duration of the two study components is 5 years. Women will remain in the study for follow-up for 2 to 5 years, depending on when they enroll. Infants will remain in the study through 74 to 104 weeks of age. Follow-up for all women and infants will be completed by the end of September 2016. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV

• NCT number: NCT01253538
• Study type: Interventional
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Completion date: September 2016