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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
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 :
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
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reinforced preventive ARV therapy | Drug | If the mother is HIV-1 or HIV 1/2 infected:
If the mother is HIV-2 infected: - zidovudine / laminvudine (60/30 mg), ¼ cp morning and evening orally for 12 weeks. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillaume Breton, MD | Solthis | Principal Investigator |
| Mohamed Cisse, MD | CHU Donka | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital National Ignace Deen | Conakry | Guinea |
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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.
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• 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 |
• 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 |