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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 |
|---|---|
| Information provided by: | French National Agency for Research on AIDS and Viral Hepatitis |
| ClinicalTrials.gov Identifier: | NCT00640263 |
Purpose
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:
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: lopinavir/ritonavir (LPV/r) Drug: Lamivudine (3TC) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official 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 |
| Estimated Enrollment: | 1500 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
infant peri-exposure prophylaxis with lopinavir/ritonavir
|
Drug: lopinavir/ritonavir (LPV/r)
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.
|
|
2: Active Comparator
infant peri-exposure prophylaxis with lamivudine
|
Drug: Lamivudine (3TC)
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.
|
Eligibility| 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:
Contacts and Locations| 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) |
More Information
| 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: | September 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00640263 History of Changes |
| 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 lopinavir/ritonavir |
|
Anti-Infective Agents HIV Protease Inhibitors Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Lamivudine Antiviral Agents Immunologic Deficiency Syndromes Protease Inhibitors |
Reverse Transcriptase Inhibitors Virus Diseases Lopinavir Anti-Retroviral Agents HIV Infections Ritonavir Sexually Transmitted Diseases Retroviridae Infections |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Lamivudine Infection Reverse Transcriptase Inhibitors Lopinavir Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors HIV Protease Inhibitors RNA Virus Infections |
Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases HIV Infections Ritonavir Sexually Transmitted Diseases Lentivirus Infections |
