Skip to main content
OpenTrials
Completed

NCT Number: NCT00640263

Comparison of Efficacy and Safety of Infant Peri-exposure Prophylaxis With Lopinavir/Ritonavir Versus Lamivudine to Prevent HIV-1 Transmission by Breastfeeding

The ANRS 12174 study is a clinical trial that will compare the efficacy and safety of prolonged infant peri-exposure prophylaxis (PEP) with Lopinavir/Ritonavir (LPV/r) versus Lamivudine to prevent HIV-1 transmission through breast milk in children born to HIV-1-infected mothers not eligible for HAART and having benefited from perinatal antiretroviral (ART) regimens. The study will recruit 1500 mother-infant pairs in 4 African countries.

Study design:

PROMISE PEP is a multinational, randomised double-blind controlled clinical trial.

Intervention:

Infants will be randomised to receive LPV/r or 3TC twice daily from day seven (± 2 days) after birth until 4 weeks after cessation of breastfeeding (BF). We will recommend exclusive BF (EBF) up till including the 26th week of life followed by a relatively rapid (maximum of 8 weeks) cessation period. The maximum duration of PEP will thereby be 38 weeks.

Primary objective:

To compare the efficacy of infant LPV/r (40/10mg twice daily if 2-4kg and 80/20mg twice daily if >4kg) vs. Lamivudine 7,5mg twice daily if 2-4kg, 25mg twice daily if 4-8kg and 50mg twice daily if >8kg) from day 7 until 4 weeks after cessation of BF (maximum duration of prophylaxis: 50 weeks for a maximum duration of breastfeeding of 46 weeks) to prevent postnatal HIV-1 acquisition between 7 days and 50 weeks of age.

Secondary objectives:

* To assess the safety of long-term infant prophylaxis with LPV/r versus Lamivudine (including resistance, adverse events and growth) until 50 weeks. * HIV-1-free survival until 50 weeks * To build clinical trials capacity at the four study sites.

Main endpoint:

Acquisition of HIV-1 (as assessed by HIV-1 DNA PCR) between day 7 and 50 weeks of age

Study population:

HIV-uninfected infants at day 7 (± 2 days) born to HIV-1 infected mothers not eligible for HAART who choose to breastfeed their infants and who have benefited from the national prevention of mother to child transmission (PMTCT) program during pregnancy and delivery. The study will recruit 1500 mother-infant pairs in Burkina Faso, South Africa, Uganda and Zambia.

Study duration:

Infants will be followed up for 50 weeks and the total study duration is five years.

Expected outcome:

This study will inform on the relative advantages (efficacy) and drawbacks of two interventions to support HIV-1-infected women not eligible for HAART to safely breastfeed their babies. If found to be safe and efficacious, the regimens would avoid the existing contradiction between optimal infant feeding and the prevention of MTCT through breast milk. Clinical trial capacity development will improve the future quality of trials conducted in these countries.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Infections Behavior Blood-Borne Infections Breast Feeding Communicable Diseases Feeding Behavior Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

5 day–9 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Université de Ouagadougou, Ouagadougou, Burkina Faso

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

A baby will be included if she/he:

  • is a singleton
  • is breastfed at day 7 by her/his mother and her/his mother intends to continue breastfeeding for at least 6 months
  • has a post-partum blood sample with a negative HIV-1 DNA PCR test result at day 7 (+/- 2 days)
  • has received ART as part of PMTCT

and if the mother:

  • has reached the local legal age for participating in medical research studies
  • is shown to be HIV-1 infected (with or without HIV-2 infection) and is not eligible for HAART or is not taking HAART
  • has received a perinatal antiretroviral prophylaxis during pregnancy and delivery,
  • has a CD4 count above the threshold of HAART initiation in pregnant women according to the national recommendation in each site (minimum 230 cells/µL),
  • resides within the study area and is not intending to move out of the area in the next year
  • gives assent for the infant to participate and gives consent to participate

Exclusion criteria

  • S/he presents clinical symptoms and/or biological abnormalities equal to or greater than grade II of the ANRS classification for adverse event on the day of enrolment
  • S/he presents with serious congenital malformation(s)
  • Her/his birth weight is lower than 2.0 kg
  • Her/his antiretroviral prophylaxis is extending beyond day 7
  • The mother has participated in the trial for a previous pregnancy
  • S/he and her/his mother are participating in another clinical trial on the day of enrolment

Treatment and study plan

lopinavir/ritonavir (LPV/r)

Drug

Oral liquid formulation lopinavir/ritonavir(80 mg lopinavir + 20 mg ritonavir/mL); Dosing : 40/10mg twice daily if infant weight is between 2 to 4 kg and 80/20mg twice daily if infant weight is above 4kg The lopinavir/ritonavir will be given to the baby from Day 7 postnatal until 4 weeks after the cessation of breastfeeding. During the treatment period, dosing will be adapted according to the infant weight.

Lamivudine (3TC)

Drug

Oral liquid solution lamivudine(10 mg/mL). Dosing : 7,5 mg twice daily if if infant weight is between 2 to 4 kg ; 25 mg twice daily if infant weight is between 4 to 8 kg ; 50 mg twice daily if infant weight is above 8kg.

The lamivudine will be given to the baby from Day 7 postnatal until 4 weeks after the cessation of breastfeeding. During the treatment period, dosing will be adapted according to the infant weight.

Primary outcomes

  1. Acquisition of HIV-1 (as determined by HIV-1 DNA PCR)

    Time frame: between day 7 and 50 weeks of age

Secondary outcomes

  1. HIV-1 free survival

    Time frame: at 50 weeks of age

  2. HIV-1 free survival

    Time frame: at one year of age

  3. safety of long-term prophylaxis

    Time frame: until 50 weeks of age

  4. safety of long-term prophylaxis

    Time frame: until one year of age

Sponsors and collaborators

Lead sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Other Gov

Collaborators

  • European and Developing Countries Clinical Trials Partnership (EDCTP)
  • Swedish International Development Cooperation Agency (SIDA)
  • The Research Council of Norway
  • University of Bergen
  • Université Montpellier

Registry information

Official study title

A Randomised Controlled Trial Comparing the Efficacy of Infant Peri-exposure Prophylaxis With Lopinavir/Ritonavir (LPV/r) Versus Lamivudine to Prevent HIV-1 Transmission by Breastfeeding

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Mar 21, 2008
Registry last updated
Apr 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.