HIV Diagnosis and Treatment at Birth for Newborn With High Risk HIV Exposure
DIAVINA
Sponsor study identifier
interventional
56
1 country
1
Study Start
February 22, 2017
Actual (reported)Primary Completion
September 17, 2019
Actual (reported)Study Completion
September 17, 2019
Actual (reported)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\*\* .
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 17, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 22, 2017
Actual (reported)March 20, 2017
Actual (reported)August 22, 2018
Actual (reported)September 17, 2019
Actual (reported)September 17, 2019
Actual (reported)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
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
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
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)
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hôpital National Ignace Deen
Conakry, Guinea
Guillaume Breton, MD
Solthis
Mohamed Cisse, MD
CHU Donka
56 participants (actual enrollment reported by the registry).
First Submitted
March 20, 2017
First Posted
August 22, 2018
Contact the study team to confirm eligibility.
Study Start
February 22, 2017
Actual (reported)Primary Completion
September 17, 2019
Actual (reported)Study Completion
September 17, 2019
Actual (reported)Last Updated
October 22, 2019
Record last verified: 2019-10
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Source: ClinicalTrials.gov.
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