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

ANRS, Emerging Infectious Diseases

Status and phase: Completed; Phase 4

Conditions: Mother to Child HIV Transmission

Treatments: Drug: Reinforced preventive ARV therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03642704

ANRS12344-DIAVINA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

56 participants in 1 patient group

Reinforced preventive ARV therapy

Experimental group

Description:

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)

Treatment:

Drug: Reinforced preventive ARV therapy