drugset / Trial / NCT03642704

HIV Diagnosis and Treatment at Birth for Newborn With High Risk HIV Exposure

NCT03642704

Phase 4 Completed 56 enrolled ANRS, Emerging Infectious Diseases
NaSingle-groupOpen-labelTreatment

Summary

Principal objective Assess the operational efficacy of a strategy combining early diagnosis and preventive antiretroviral treatment systematically reinforced from the birth\* among infants at high risk of infection with HIV\*\* . * in a maximum of 48 hours after delivery * born from HIV infected mothers who received less than 4 weeks of antiretroviral therapy prior delivery and / or HIV infection diagnosed at delivery Intervention, a combined strategy : After positive HIV infection screening from mother in the delivery room and put on antiretroviral treatment of mothers with post partum according to national guidelines , newborns benefit : * Early detection of HIV infection at birth * Without awaiting the outcome of early detection result, a preventive reinforced antiretroviral treatment (zidovudine, lamivudine, nevirapine or zidovudine, lamivudine if their mother is infected with HIV-2), from birth for 12 weeks. * Regular HIV screening until the end of breastfeeding or later to 18 months. * In case of positive results of an HIV test, an antiretroviral treatment with zidovudine, lamivudine, lopinavir, ritonavir whatever serology HIV 1 or 2.

Timeline

Start
2017-02-22
Primary completion
2019-09-17
Completion
2019-09-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Lamivudine Other / unclassified 30 mg Oral
Subject Nevirapine Small molecule 2 mg/kg Oral
Subject Nevirapine Small molecule 10 mg Oral
Subject Nevirapine Small molecule 15 mg Oral
Subject Zidovudine Small molecule 60 mg Oral

Indications

No indication recorded.