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

NCT03642704 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2019-10-22

No results posted yet for this study

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.

Conditions

  • Mother to Child HIV Transmission

Interventions

DRUG

Reinforced preventive ARV therapy

If the mother is HIV-1 or HIV 1/2 infected: * zidovudine / laminvudine (60/30 mg), ¼ cp morning and evening orally for 12 weeks. * nevirapine: 15mg/OD if weight ≥ 2500g / 10mg/OD if weight = 2000-2499g / 2mg/kg/OD if weight \< 2000g for 12 weeks in case of HIV-1 infection. After 6 weeks, nevirapine will increase at 20mg/OD If the mother is HIV-2 infected: \- zidovudine / laminvudine (60/30 mg), ¼ cp morning and evening orally for 12 weeks.

Sponsors & Collaborators

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Principal Investigators

  • Guillaume Breton, MD · Solthis

  • Mohamed Cisse, MD · CHU Donka

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Guinea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03642704 on ClinicalTrials.gov