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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Mother to Child HIV Transmission

Intervention / Treatment
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* Drug: Reinforced preventive ARV therapy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reinforced preventive ARV therapy<br>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<br>* 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.<br>* Other names: Early diagnosis in children exposed to HIV;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PMTCT, HIV early diagnosis, HIV preventive therapy, prevention of mother to child HIV transmission