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

NCT03642704 | Completed Phase 4 DMC

• 1 other identifier: ANRS12344-DIAVINA
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

PMTCT; HIV early diagnosis; HIV preventive therapy; prevention of mother to child HIV transmission

Outcome Measures

Primary Outcomes (1)

• Proportion of newborns who have received an HIV diagnosis and reinforced preventive antiretroviral treatment at birth.

  Proportion of newborns who have received both HIV test and reinforced preventive antiretroviral treatment in a maximum of 48 hours after birth.

  Day 2

Secondary Outcomes (4)

• Proportion of mothers diagnosed with HIV who will initiate an antiretroviral therapy

  Week 72

• Proportion of children diagnosed with HIV who will initiate an antiretroviral therapy

  Week 72

• Proportion of mother-child pairs retained in the study with child having 2 PCR performed after stopping reinforced preventive antiretroviral treatment

  Week 24

• Proportion of mother-child pairs retained in the study

  Week 72

Other Outcomes (17)

• Measure the clinical tolerance of reinforced preventive antiretroviral treatment in children

  Week 12

• Measure the biological tolerance of reinforced preventive antiretroviral treatment in children

  Week 12

• Measure the proportion of children on reinforced preventive antiretroviral treatment with anemia

  Week 12

Study Arms (1)

Reinforced preventive ARV therapy

EXPERIMENTAL

The proposed reinforced preventive ARV Therapy will be administrated to all newborns exposed to HIV (zidovudine+lamivudine+nevirapine if the newborn is exposed to HIV-1 or HIV-1/2, zidovudine+lamivudine if the newborns exposed to HIV-2)

Drug: Reinforced preventive ARV therapy

Interventions

Reinforced preventive ARV therapy DRUG

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.

Also known as: Early diagnosis in children exposed to HIV

Reinforced preventive ARV therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Mother treated with antiretrovirals during the month preceding delivery
• 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

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Study Sites (1)

Hôpital National Ignace Deen

Conakry, Guinea

Location

Study Officials

• Guillaume Breton, MD

  Solthis

  PRINCIPAL INVESTIGATOR

• Mohamed Cisse, MD

  CHU Donka

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Prospective non-comparative study of mother-child pairs whose mother is HIV-infected and received less than 4 weeks of antiretroviral therapy before birth or whose HIV infection has been diagnosed at birth. 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.

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: August 22, 2018
• Study Start: February 22, 2017
• Primary Completion: September 17, 2019
• Study Completion: September 17, 2019
• Last Updated: October 22, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1)