Status:
COMPLETED
Comparison of Efficacy and Safety of Infant Peri-exposure Prophylaxis With Lopinavir/Ritonavir Versus Lamivudine to Prevent HIV-1 Transmission by Breastfeeding
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborating Sponsors:
European and Developing Countries Clinical Trials Partnership (EDCTP)
The Research Council of Norway
Conditions:
HIV Infections
Eligibility:
All Genders
5-9 years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2014
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT00640263
Start Date
December 1 2009
End Date
February 1 2014
Last Update
April 14 2014
Active Locations (4)
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1
Université de Ouagadougou
Ouagadougou, Burkina Faso
2
East London Hospital Complex
East London, South Africa
3
Dept of Paediatrics and Child Health, Makerere University
Kampala, Uganda
4
Dept of Paediatrics and Child Health, School of Medicine, University of Zambia
Lusaka, Zambia