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

HIV Diagnosis and Treatment at Birth for HIV Exposed Newborn Whose Mother Was Not Treated With Antiretroviral Therapy (ART) During Last Month Before Delivery : Strategy Evaluation in Guinea.

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.

Study Overview

• Status: Completed
• Conditions: Mother to Child HIV Transmission
• Intervention / Treatment: Drug: Reinforced preventive ARV therapy

Detailed Description

Objectives 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 Secondary objectives

• Measure the cascade management of HIV infected mothers and HIV infected infants
• Measure the tolerance of reinforced preventive antiretroviral treatment
• Describe the rate of mother to child transmission of HIV and its risk factors
• Describe the clinical and immuno-virologic outcomes in mothers, in HIV infected children and in HIV-non-infected children
• Evaluate the acceptability of the strategy by mothers and caregivers.
• Compare the early diagnosis of HIV infection with Abbott and Biocentric HIV RNA tests

Methodology 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.

Estimated enrolment: 300 mother-child pairs

Eligibility:

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.

non-inclusion 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 Contra-indications to the study drugs 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

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 (AZT / 3TC / NVP or AZT / 3TC 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 AZT / 3TC / LPV whatever serology HIV 1 or 2.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 4

Contacts and Locations

Study Locations

• Guinea
  • Conakry, Guinea
    • Hopital National Ignace Deen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Reinforced preventive ARV therapy; 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; 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.; Other Names: Early diagnosis in children exposed to HIV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of mothers diagnosed with HIV who will initiate an antiretroviral therapy	• Proportion of mothers diagnosed with HIV at Day 0 who will initiate an antiretroviral therapy	Week 72
Proportion of children diagnosed with HIV who will initiate an antiretroviral therapy	• Proportion of children diagnosed with HIV from Day 0 to Week 72 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	• Proportion of mother-child pairs retained in the study from Day 0 to Week 24 with child having 2 PCR performed after stopping reinforced preventive antiretroviral treatment	Week 24
Proportion of mother-child pairs retained in the study	• Proportion of mother-child pairs retained in the study from Day 0 to Week 72.	Week 72

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure the clinical tolerance of reinforced preventive antiretroviral treatment in children	• Nature of clinical adverse events	Week 12
Measure the biological tolerance of reinforced preventive antiretroviral treatment in children	• Nature of biological adverse events	Week 12
Measure the proportion of children on reinforced preventive antiretroviral treatment with anemia	• Proportion of children with anemia superior or equal to grade 2	Week 12
Measure the proportion of children who change antiretroviral therapy for grade 4 adverse event	• Proportion of children who change antiretroviral therapy for grade 4 adverse event	Week 12
Measure the proportion of children with preventive antiretroviral treatment interruption	• Proportion of children with preventive antiretroviral treatment interruption	Week 12
Describe the clinical events occurring in mothers	• Description of clinical events occurring in mothers	Week 72
Measure the proportion of mothers presenting clinical events	• Proportion of mothers presenting clinical events	Week 72
Describe the immunological outcomes in mothers	• Value of CD4 (absolute number)	Week 72
Describe the virological outcomes in mothers	• Value of HIV RNA (copies/mL)	Week 72
Describe the clinical outcomes in HIV-infected children	• Description of clinical events occurring in HIV-infected children	Week 48
Measure the proportion of HIV-infected children presenting clinical events	• Proportion of HIV-infected children presenting clinical events	Week 48
Describe the immunological outcomes in HIV infected children	• Value of CD4 (absolute number)	Week 48
Describe the virological outcomes in HIV infected children	• Value of HIV RNA (copies/mL)	Week 48
Describe the clinical outcomes in HIV-non-infected children	Nature of clinical events occurring in HIV-non-infected children	Week 72
Measure the proportion of HIV-non-infected children presenting clinical events	• Proportion of HIV-non-infected children presenting clinical events	Week 72
Describe the rate of mother to child transmission of HIV	• Proportion of HIV infected children (based on PCR ADN or ARN)	Week 72
Describe the risk factors of mother to child transmission of HIV	Description of risk factors for HIV transmission	week 72

Collaborators and Investigators

• Sponsor: ANRS, Emerging Infectious Diseases
• Investigators: Principal Investigator: Guillaume Breton, MD, Solthis; Principal Investigator: Mohamed Cisse, MD, CHU Donka

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2017
• Primary Completion (Actual): September 17, 2019
• Study Completion (Actual): September 17, 2019

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (Actual): August 22, 2018

Study Record Updates

• Last Update Posted (Actual): October 22, 2019
• Last Update Submitted That Met QC Criteria: October 21, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: PMTCT; HIV early diagnosis; HIV preventive therapy; prevention of mother to child HIV transmission
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: ANRS12344-DIAVINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No