Clinical trial NCT03642704: HIV Diagnosis and Treatment at Birth for Newborn With High Risk HIV Exposure
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mother to Child HIV Transmission
Keywords: PMTCT
HIV early diagnosis
HIV preventive therapy
prevention of mother to child HIV transmission
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2018-08-22
Enrollment: 56
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Proportion of newborns who have received an HIV diagnosis and reinforced preventive antiretroviral treatment at birth.
timeFrame: Day 2
Secondary outcomes:
measure: Proportion of mothers diagnosed with HIV who will initiate an antiretroviral therapy
timeFrame: Week 72
measure: Proportion of children diagnosed with HIV who will initiate an antiretroviral therapy
timeFrame: Week 72
measure: Proportion of mother-child pairs retained in the study with child having 2 PCR performed after stopping reinforced preventive antiretroviral treatment
timeFrame: Week 24
measure: Proportion of mother-child pairs retained in the study
timeFrame: Week 72
Other outcomes:
measure: Measure the clinical tolerance of reinforced preventive antiretroviral treatment in children
timeFrame: Week 12
measure: Measure the biological tolerance of reinforced preventive antiretroviral treatment in children
timeFrame: Week 12
measure: Measure the proportion of children on reinforced preventive antiretroviral treatment with anemia
timeFrame: Week 12
measure: Measure the proportion of children who change antiretroviral therapy for grade 4 adverse event
timeFrame: Week 12
measure: Measure the proportion of children with preventive antiretroviral treatment interruption
timeFrame: Week 12
measure: Describe the clinical events occurring in mothers
timeFrame: Week 72
measure: Measure the proportion of mothers presenting clinical events
timeFrame: Week 72
measure: Describe the immunological outcomes in mothers
timeFrame: Week 72
measure: Describe the virological outcomes in mothers
timeFrame: Week 72
measure: Describe the clinical outcomes in HIV-infected children
timeFrame: Week 48
measure: Measure the proportion of HIV-infected children presenting clinical events
timeFrame: Week 48
measure: Describe the immunological outcomes in HIV infected children
timeFrame: Week 48
measure: Describe the virological outcomes in HIV infected children
timeFrame: Week 48
measure: Describe the clinical outcomes in HIV-non-infected children
timeFrame: Week 72
measure: Measure the proportion of HIV-non-infected children presenting clinical events
timeFrame: Week 72
measure: Describe the rate of mother to child transmission of HIV
timeFrame: Week 72
measure: Describe the risk factors of mother to child transmission of HIV
timeFrame: week 72
Locations:
city: Conakry
country: Guinea
facility: Hôpital National Ignace Deen
Study officials:
affiliation: Solthis
name: Guillaume Breton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Donka
name: Mohamed Cisse, MD
role: PRINCIPAL_INVESTIGATOR
References: