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Sponsors and Collaborators: |
French National Agency for Research on AIDS and Viral Hepatitis Europe Developing Countries Clinical Trials Partnership (EDCTP) The Research Council of Norway Swedish International Development Cooperation Agency Université Montpellier University of Bergen |
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Information provided by: | French National Agency for Research on AIDS and Viral Hepatitis |
ClinicalTrials.gov Identifier: | NCT00640263 |
The PROMISE PEP study is a clinical trial that will measure the efficacy and the safety of prolonged peri-exposure prophylaxis (PEP) with lamivudine (3TC) 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 placebo-controlled clinical trial.
Intervention:
Infants will be randomised to receive 3TC or placebo once 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:
Secondary objectives:
Main endpoint:
Acquisition of HIV-1 (as determined by HIV-1 DNA PCR) between day 7 and 38 weeks of age.
Study population:
Seronegative 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 a standard 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 one year and the total study duration is five years.
Expected outcome:
This study will measure the efficacy of a new drug regimen to support HIV-1-infected women not eligible for HAART to safely breastfeed their babies for 34 weeks. If found to be sufficiently efficacious, the regimen would contribute to counteract the existing contradiction between optimal infant feeding and MTCT through breast milk.
Condition | Intervention | Phase |
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HIV Infections |
Drug: lamivudine (3TC) Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Double Blind Randomised Placebo-Controlled Trial of the Efficacy and Safety of Infant Peri-Exposure Prophylaxis With Lamivudine to Prevent HIV-1 Transmission by Breastfeeding |
Estimated Enrollment: | 1500 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
infant peri-exposure prophylaxis with lamivudine
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Drug: lamivudine (3TC)
The study drug is the commercial oral suspension of paediatric lamivudine (10mg/mL); Daily dose of 2.4 ml of the 3TC suspension will be given to the baby from Day 7 postnatal, followed by 4.8 ml daily as soon as her/his body weight exceeds 6 kg (as measured at a monthly hospital visit) and 7.2 ml daily when her/his body weight exceeds 9 kg until 4 weeks after the cessation of breastfeeding.
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2: Placebo Comparator
Placebo
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Drug: Placebo
The placebo will be similar to the 3TC oral suspension ; Daily dose of 2.4 ml of the placebo will be given to the baby from Day 7 postnatal, followed by 4.8 ml daily as soon as her/his body weight exceeds 6 kg (as measured at a monthly hospital visit) and 7.2 ml daily when her/his body weight exceeds 9 kg until 4 weeks after the cessation of breastfeeding.
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Ages Eligible for Study: | up to 9 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: A baby will be included if she/he:
and if the mother:
Exclusion Criteria:
Contact: Philippe Vande Perre, MD, PhD | +33 467336886 | p-van_de_perre@chu-montpellier.fr |
Contact: Thorkild Tylleskär, MD, PhD | +47 55974975 | Thorkild.Tylleskar@cih.uib.no |
Burkina Faso | |
Université de Ouagadougou | |
Ouagadougou, Burkina Faso | |
South Africa, Western Cape | |
University of Western Cape | |
Cape Town, Western Cape, South Africa, 7353 | |
Uganda | |
Dept of Paediatrics and Child Health, Makerere University | |
Kampala, Uganda | |
Zambia | |
Dept of Paediatrics and Child Health, School of Medicine, University of Zambia | |
Lusaka, Zambia |
Study Chair: | Philippe Vande Perre, MD, PhD | University of Montpellier, France |
Study Chair: | Thorkild Tylleskär, MD, PhD | Centre For International Health |
Principal Investigator: | Nicolas Meda, MD, PhD | University of Ouagadougou, Burkina Faso |
Principal Investigator: | James K Tumwine, MD, PhD | Dept of Paediatrics and Child Health, Makerere University, Uganda |
Principal Investigator: | Chipepo Kankasa, MD | Dept of Paediatrics and Child Health, School of Medicine, University of Zambia |
Principal Investigator: | Cheryl Nikodem, DCurMCurBCur | University of the Western Cape, South Africa |
Principal Investigator: | Eva-Charlotte Ekström, PhD | Uppsala University, Uppsala, Sweden |
Principal Investigator: | Stephane Blanche, MD, PhD | Hôpital Necker Enfants Malades, Université Paris V (EA 3620) |
Responsible Party: | French National Agency for Research on AIDS and Viral Hepatitis ( Claire Rekacewicz ) |
Study ID Numbers: | ANRS 12174 PROMISE-PEP, EDCTP : RCN 183600 |
Study First Received: | January 15, 2008 |
Last Updated: | October 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00640263 |
Health Authority: | South Africa: Medicines Control Council; Zambia: Ministry of Health; Uganda: National Council for Science and Technology; Burkina Faso: Ministry of Health |
HIV-1 Breastfeeding Prevention lamivudine |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Lamivudine Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |