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

• Status: Completed
• Trial end date: 2019-09-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Treatments: Nevirapine; Zidovudine

Criteria

Inclusion Criteria:

• Mother-child pairs whose mother is HIV-infected and received less than 4 weeks of antiretroviral therapy before delivery or whose HIV infection has been diagnosed at delivery

• Mother who signed the informed consent form to participate in the study.

Exclusion Criteria:

• Mother treated with antiretrovirals during the month preceding delivery

• No inclusion for precautionary reason : clinical symptoms suggesting an opportunistic infection of the central nervous system.

• No inclusion for monitoring difficulties

• History or presence of allergy to the study drugs or their components

• Symptoms, physical signs or laboratory values suggestive of systemic disorders, (including renal, hepatic, cardiovascular, pulmonary, skin, or psychiatric and other conditions, which could interfere with the interpretation of the trial results