Mother to Child HIV Transmission Clinical Trial
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.
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05017558 -
Evaluation of Measurement of Maternal Viral Load at Delivery to Optimise Post-natal Prophylaxis of HIV-exposed Newborns
|