Mother to Child HIV TransmissionPhase 4DIAVINANCT03642704
HIV Diagnosis and Treatment at Birth for Newborn With High Risk HIV Exposure
A Phase 4 study testing Reinforced preventive ARV therapy in people with Mother to Child HIV Transmission, run by ANRS, Emerging Infectious Diseases at 1 site in Guinea.
Trial summary
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** . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mother to Child HIV Transmission
- What is being tested?
- Reinforced preventive ARV therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteGuinea
- Study dates
- 22 Feb 2017to 17 Sep 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
Read more
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.
Read the detailed 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.
- Conditions
- Mother to Child HIV Transmission
- Being tested
- Reinforced preventive ARV therapy
- Keywords
- PMTCT, HIV early diagnosis, HIV preventive therapy, prevention of mother to child HIV transmission
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reinforced preventive ARV therapyDrug
Also called Early diagnosis in children exposed to HIV
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Reinforced preventive ARV therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 2
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: Week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start22 Feb 2017
- Primary completion17 Sep 2019
- Study completion17 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mother to Child HIV TransmissionStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Guillaume Breton, MD, Principal investigator, SolthisMohamed Cisse, MD, Principal investigator, CHU Donka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642704
- Sponsor's protocol ID
- ANRS12344-DIAVINA
- Acronym
- DIAVINA
- Status last verified
- Oct 2019
- First submitted
- 20 Mar 2017
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03642704
- Acronym / sponsor ID
- DIAVINA / ANRS12344-DIAVINA
- Conditions
- Mother to Child HIV Transmission
- Keywords
- PMTCT, HIV early diagnosis, HIV preventive therapy, prevention of mother to child HIV transmission
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Reinforced preventive ARV therapy | Experimental | Drug: Reinforced preventive ARV therapyThe 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reinforced preventive ARV therapyAlso: Early diagnosis in children exposed to HIVIf 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. | Drug | Reinforced preventive ARV therapy |
Primary outcome
Proportion of newborns who have received an HIV diagnosis and reinforced preventive antiretroviral treatment at birth.
Time frame: Day 2
Proportion of newborns who have received both HIV test and reinforced preventive antiretroviral treatment in a maximum of 48 hours after birth.
4 secondary outcomes
Proportion of mothers diagnosed with HIV who will initiate an antiretroviral therapy
Time frame: Week 72
Proportion of children diagnosed with HIV who will initiate an antiretroviral therapy
Time frame: Week 72
Proportion of mother-child pairs retained in the study with child having 2 PCR performed after stopping reinforced preventive antiretroviral treatment
Time frame: Week 24
Proportion of mother-child pairs retained in the study
Time frame: Week 72
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Breton, MD principal investigator
Solthis
Mohamed Cisse, MD principal investigator
CHU Donka
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Reinforced preventive ARV therapy in people with Mother to Child HIV Transmission, run by ANRS, Emerging Infectious Diseases at 1 site in Guinea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guinea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of newborns who have received an HIV diagnosis and reinforced preventive antiretroviral treatment at birth. (time frame: Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2019.