HIV-1Phase 2PREVENIR-PEVNCT03869944
Preventing Childhood HIV: Rescue Intervention. ANRS 12388 PREVENIR-PEV
A Phase 2 study testing Lamivudine Oral Solution in people with HIV-1, run by ANRS, Emerging Infectious Diseases at 1 site in Burkina Faso.
Trial summary
The second visit of the Expanded Programme of Immunization when the child is 2 months old (EPI-2) represents a unique opportunity to link the EPI and PMTCT programmes and to introduce preventive and therapeutic rescue interventions in order to 1) Assess the efficacy of the PMTCT cascade up to 2 months postpartum; 2)… Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- HIV-1
- What is being tested?
- Lamivudine Oral Solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 4 Dec 2019to Mar 2022
- Phase
- Phase 2
- 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 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A mother-child couple will be included in the Phase IIb trial if the child:
- is a singleton
- is breastfed at about 2 months and the mother intends to continue breastfeeding for at least 4 months (until her child is 6 months old)
- has a POC HIV-1 PCR negative test at about 2 months of age
- has a mother who:
- accompanies him to visit 2 of the EPI
Show all 11Show fewer
- is over 20 years of age or over or is a minor from the age of 15 and is accompanied by a referent adult of his/her choice representing his/her interests (parent, family member or guardian, member of an association, etc.)
- has been confirmed to be infected with HIV-1 (with or without HIV-2)
- signature of the consent to participate
- for the mother signed by herself and a witness (if illiterate) and/or a referent adult (if under 20 years of age)
- for the child: consent must be signed by both parents unless the mother exercises parental authority alone or if obtaining the father's consent is likely to endanger the mother and her child.
Who cannot join
- A mother-child couple will not be included in the Phase IIb trial if the child:
- exhibits DAIDS grade 3 or 4 clinical symptoms or biological anomalies for adverse events on the day of inclusion
- has a severe congenital malformation
- has a known allergy to the study drug or its components
- is taking emtricitabine concomitantly
- has a mother:
- living outside the study area or planning to move from the area within the next 12 months
- participating in another clinical trial on the day of inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Elimination of Paediatric HIV-1 Infection: Evaluation of the Prevention Programme and Rescue Intervention Based on the Expanded Programme on Immunization (EPI). ANRS 12388 PREVENIR-PEV Study.
The second visit of the Expanded Programme of Immunization when the child is 2 months old (EPI-2) represents a unique opportunity to link the EPI and PMTCT programmes and to introduce preventive and therapeutic rescue interventions in order to 1) Assess the efficacy of the PMTCT cascade up to 2 months postpartum; 2) Allow at least 80% of HIV-1-infected infants identified at the second EPI visit who were not involved in HIV care to initiate ARVs at the earliest, but no later than 2 months after confirmation of HIV diagnosis; 3) Reduce HIV-1 transmission to less than 3% between 2 and 12 months among exposed children who completed the second EPI visit
Read the detailed description
The WHO recommendation of lifelong antiretroviral therapy (ART) for all HIV-infected pregnant or breastfeeding women represents a major advance for universal access to HIV care but this strategy alone may not be sufficient to eliminate pediatric HIV in the communities.
Presently, the impact of prevention of mother-to-child HIV transmission (PMTCT) programs in the communities is unclear. There is also no available rescue intervention able to identify postpartum women at high risk of transmission in order to offer them adequate HIV care and prevent HIV acquisition by their breastfed infants.
We hypothesize that the second visit for routine vaccination (Expanded Program of Immunization visit 2, EPI-2) represents a unique opportunity to link EPI and PMTCT programs and introduce rescue preventive and therapeutic interventions.
The study will assess the efficacy of the PMTCT cascade up to 2 months post-partum for all mothers attending the EPI-2 (Component 1). For Component 1, the target population will be all 32,100 women participating in EPI-2 and verbally consenting to participate to evaluate the PMTCT program up to 2 months postpartum.
The consent form for component 2 will be proposed to all HIV positive mothers of component 1 who meet the inclusion and non-inclusion criteria. HIV-1 viral load measurement of the mothers and the detection of HIV-1 DNA in their children will be assessed. Children infected with HIV-1 will be referred for immediate ART initiation.
For Component 2 - phase IIb trial (N = 300 mother-infant pairs) - the target population will be HIV positive breastfeeding mothers aged 15 years or older with a child whose tests so far do not reveal the existence of infection (at EPI-2 visit) to assess the effectiveness of a rescue intervention for Prevention of Mother-to-Child Transmission of HIV up to 12 months of age.
The target population to receive PrEP (lamivudine) until 12 months of age (or until confirmed end of breastfeeding) will be women with unsuppressed HIV-1 infection (≥1000 copies of HIV-1 RNA/ml) with a child whose tests to date (EPI-2 visit) do not reveal the existence of infection.
HIV-1 infected women with suppressed (<1000 copies of HIV-1 RNA/ml) viral load at the time of the EPI-2 visit will be followed at 6 and 12 months. If at 6 months the mother become virally unsuppressed, her child will receive ARV medication up to 12 months of age (or the confirmed end of breastfeeding) to prevent infection.
The control group does not apply to this study. The overall mother-to-child transmission rate is the WHO target for the elimination of paediatric HIV-1: 5% at one year of life (consistent with a 3% postnatal transmission rate between 2 and 12 months of age of the child).
- Conditions
- HIV-1
- Being tested
- Lamivudine Oral Solution
- Keywords
- HIV-1, PMTCT, Point of Care, PrEP, Burkina Faso, Expanded Program of Immunization (EPI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamivudine Oral SolutionDrug
During the EPI-2 visit, HIV-1 negative children of mothers with a unsuppressed plasma HIV-1 VL (≥ 1000 copies/mL) will be initiated on PrEP, lamivudine syrup (7.5 mg twice daily if 2 to 4 kg; 25 mg twice a day if weight <8 kg; and 50 mg twice a day if weight >8 kg) for 10 months, until the child is 12 months old. A monitoring on the mother's VL and child's diagnosis will take place at 6 and 12 months.
Mothers with unsuppressed plasma HIV-1 VL (< 1000 copies/mL) and HIV-1 negative children will not be offered PrEP but the mother's VL and child diagnosis will be monitored at 6 and 12 months: If the VL is ≥ 1000 copies/mL, the child will be initiated on PrEP until the child is 12 months old.
Children infected with HIV-1 will be referred to the National Program for immediate ART.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Lamivudine Oral Solution Receives: Drug: Lamivudine Oral Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of HIV-1 transmission from HIV-1-positive mothers to their breastfeeding children
Postnatal HIV-1 transmission rates at 12 months in infants exposed to HIV-1 through breastfeeding.
Measured: 12 months
Secondary outcomes (4)
Efficacy of PMTCT cascade - mother
Proportion of EPI-2 women who did not attend PMTCT clinic at least once during pregnancy (as per the records in the antenatal care clinics): Proportion who received an HIV-1 test in the three previous months (as per the records in the antenatal care clinics); Proportion of women infected with HIV-1 and Proportion with undetectable plasma viral load (<1000 copies of HIV RNA/mL) (as per the results obtained with the Point of Care HIV-1 PCR Viral Load in the study), Proportion of mothers who started antiretroviral treatment during pregnancy or after delivery (as per the records in the antenatal care clinics)
Measured: 2 months
Efficacy of PMTCT cascade - child
Proportion of babies with HIV-1 PCR positive (as per the results obtained with the Point of Care HIV-1 PCR Qualitative in the study); Proportion of HIV-1-infected babies engaged in HIV care at 2 months (i.e. initiated on antiretroviral treatment) (as per the data collected at the study sites following diagnosis by Point of Care HIV-1 PCR).
Measured: 2 months
Access to ART for HIV-1-positive children
Proportion of HIV-infected infants identified at the second EPI visit who were not engaged in HIV care at that time, who will be placed on ART within two months of that visit, or if they are infected during follow-up within two months of diagnosis.
Measured: 6 months
Number of Adverse Events Grade 3 and 4 in the prevention of HIV-1 via breastfeeding [Safety of lamivudine]
- Adverse event rates at 12 months, including deaths and Grade 3 or 4 events on the pediatric DAIDS scale in uninfected children exposed to HIV
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start4 Dec 2019
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV-1Studies 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase II trial, non-randomized, open-label, mono-country and multi-center trial
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Centre Muraz
- Responsible party
- Sponsor
- Investigators
- Philippe Van de Perre, MD, PhD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869944
- Sponsor's protocol ID
- ANRS 12388 PREVENIR-PEV
- Acronym
- PREVENIR-PEV
- Status last verified
- Mar 2022
- First submitted
- 4 Mar 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nagot N, Kankasa C, Tumwine JK, Meda N, Hofmeyr GJ, Vallo R, Mwiya M, Kwagala M, Traore H, Sunday A, Singata M, Siuluta C, Some E, Rutagwera D, Neboua D, Ndeezi G, Jackson D, Marechal V, Neveu D, Engebretsen IMS, Lombard C, Blanche S, Sommerfelt H, Rekacewicz C, Tylleskar T, Van de Perre P; ANRS 12174 Trial Group. Extended pre-exposure prophylaxis with lopinavir-ritonavir versus lamivudine to prevent HIV-1 transmission through breastfeeding up to 50 weeks in infants in Africa (ANRS 12174): a randomised controlled trial. Lancet. 2016 Feb 6;387(10018):566-573. doi: 10.1016/S0140-6736(15)00984-8. Epub 2015 Nov 19.
PubMed 26603917Mennecier A, Sakana BLD, D'Ottavi M, Tassembedo S, Moles JP, Kania D, Taofiki AO, Kadeba FE, Diallo I, Eymard-Duvernay S, Meda N, Mosqueira B, Fao P, Nagot N; PREVENIR-PEV Study Group; Vande Perre P. An optimized strategy triggered at the 2nd immunization visit to prevent HIV acquisition by breastfeeding: a phase 2 trial in Burkina Faso (PREVENIR-PEV). BMC Infect Dis. 2024 Sep 20;24(1):1014. doi: 10.1186/s12879-024-09910-z.
PubMed 39300364Mennecier A, Kankasa C, Fao P, Moles JP, Eymard-Duvernay S, Mwiya M, Kania D, Chunda-Liyoka C, Sakana L, Rutagwera D, Tassembedo S, Wilfred-Tonga MM, Mosqueira B, Tylleskar T, Nagot N, Van de Perre P; ANRS 12397 Study group. Design and challenges of a large HIV prevention clinical study on mother-to-child transmission: ANRS 12397 PROMISE-EPI study in Zambia and Burkina Faso. Contemp Clin Trials. 2021 Jun;105:106402. doi: 10.1016/j.cct.2021.106402. Epub 2021 Apr 17.
PubMed 33872801
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elimination of Paediatric HIV-1 Infection: Evaluation of the Prevention Programme and Rescue Intervention Based on the Expanded Programme on Immunization (EPI). ANRS 12388 PREVENIR-PEV Study.
- ClinicalTrials.gov ID
- NCT03869944
- Acronym / sponsor ID
- PREVENIR-PEV / ANRS 12388 PREVENIR-PEV
- Conditions
- HIV-1
- Keywords
- HIV-1, PMTCT, Point of Care, PrEP, Burkina Faso, Expanded Program of Immunization (EPI)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 97 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Centre Muraz
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 11 Mar 2019 (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.
The second visit of the Expanded Programme of Immunization when the child is 2 months old (EPI-2) represents a unique opportunity to link the EPI and PMTCT programmes and to introduce preventive and therapeutic rescue interventions in order to 1) Assess the efficacy of the PMTCT cascade up to 2 months postpartum; 2) Allow at least 80% of HIV-1-infected infants identified at the second EPI visit who were not involved in HIV care to initiate ARVs at the earliest, but no later than 2 months after confirmation of HIV diagnosis; 3) Reduce HIV-1 transmission to less than 3% between 2 and 12 months among exposed children who completed the second EPI visit
Detailed description
The WHO recommendation of lifelong antiretroviral therapy (ART) for all HIV-infected pregnant or breastfeeding women represents a major advance for universal access to HIV care but this strategy alone may not be sufficient to eliminate pediatric HIV in the communities.
Presently, the impact of prevention of mother-to-child HIV transmission (PMTCT) programs in the communities is unclear. There is also no available rescue intervention able to identify postpartum women at high risk of transmission in order to offer them adequate HIV care and prevent HIV acquisition by their breastfed infants.
We hypothesize that the second visit for routine vaccination (Expanded Program of Immunization visit 2, EPI-2) represents a unique opportunity to link EPI and PMTCT programs and introduce rescue preventive and therapeutic interventions.
The study will assess the efficacy of the PMTCT cascade up to 2 months post-partum for all mothers attending the EPI-2 (Component 1). For Component 1, the target population will be all 32,100 women participating in EPI-2 and verbally consenting to participate to evaluate the PMTCT program up to 2 months postpartum.
The consent form for component 2 will be proposed to all HIV positive mothers of component 1 who meet the inclusion and non-inclusion criteria. HIV-1 viral load measurement of the mothers and the detection of HIV-1 DNA in their children will be assessed. Children infected with HIV-1 will be referred for immediate ART initiation.
For Component 2 - phase IIb trial (N = 300 mother-infant pairs) - the target population will be HIV positive breastfeeding mothers aged 15 years or older with a child whose tests so far do not reveal the existence of infection (at EPI-2 visit) to assess the effectiveness of a rescue intervention for Prevention of Mother-to-Child Transmission of HIV up to 12 months of age.
The target population to receive PrEP (lamivudine) until 12 months of age (or until confirmed end of breastfeeding) will be women with unsuppressed HIV-1 infection (≥1000 copies of HIV-1 RNA/ml) with a child whose tests to date (EPI-2 visit) do not reveal the existence of infection.
HIV-1 infected women with suppressed (<1000 copies of HIV-1 RNA/ml) viral load at the time of the EPI-2 visit will be followed at 6 and 12 months. If at 6 months the mother become virally unsuppressed, her child will receive ARV medication up to 12 months of age (or the confirmed end of breastfeeding) to prevent infection.
The control group does not apply to this study. The overall mother-to-child transmission rate is the WHO target for the elimination of paediatric HIV-1: 5% at one year of life (consistent with a 3% postnatal transmission rate between 2 and 12 months of age of the child).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase II trial, non-randomized, open-label, mono-country and multi-center trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Lamivudine Oral SolutionLamivudine Oral Solution |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- is a singleton
- is breastfed at about 2 months and the mother intends to continue breastfeeding for at least 4 months (until her child is 6 months old)
- has a POC HIV-1 PCR negative test at about 2 months of age
- has a mother who:
- accompanies him to visit 2 of the EPI
Key exclusion criteria (8 listed)
- exhibits DAIDS grade 3 or 4 clinical symptoms or biological anomalies for adverse events on the day of inclusion
- has a severe congenital malformation
- has a known allergy to the study drug or its components
- is taking emtricitabine concomitantly
- has a mother:
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 |
|---|---|---|
| Lamivudine Oral SolutionDuring the EPI-2 visit, HIV-1 negative children of mothers with a unsuppressed plasma HIV-1 VL (≥ 1000 copies/mL) will be initiated on PrEP, lamivudine syrup (7.5 mg twice daily if 2 to 4 kg; 25 mg twice a day if weight <8 kg; and 50 mg twice a day if weight >8 kg) for 10 months, until the child is 12 months old. A monitoring on the mother's VL and child's diagnosis will take place at 6 and 12 months. Mothers with unsuppressed plasma HIV-1 VL (< 1000 copies/mL) and HIV-1 negative children will not be offered PrEP but the mother's VL and child diagnosis will be monitored at 6 and 12 months: If the VL is ≥ 1000 copies/mL, the child will be initiated on PrEP until the child is 12 months old. Children infected with HIV-1 will be referred to the National Program for immediate ART. | Drug | Intervention |
Primary outcome
Prevention of HIV-1 transmission from HIV-1-positive mothers to their breastfeeding children
Time frame: 12 months
Postnatal HIV-1 transmission rates at 12 months in infants exposed to HIV-1 through breastfeeding.
4 secondary outcomes
Efficacy of PMTCT cascade - mother
Time frame: 2 months
Efficacy of PMTCT cascade - child
Time frame: 2 months
Access to ART for HIV-1-positive children
Time frame: 6 months
Number of Adverse Events Grade 3 and 4 in the prevention of HIV-1 via breastfeeding [Safety of lamivudine]
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Background: PubMed 26603917Nagot N, Kankasa C, Tumwine JK, Meda N, Hofmeyr GJ, Vallo R, Mwiya M, Kwagala M, Traore H, Sunday A, Singata M, Siuluta C, Some E, Rutagwera D, Neboua D, Ndeezi G, Jackson D, Marechal V, Neveu D, Engebretsen IMS, Lombard C, Blanche S, Sommerfelt H, Rekacewicz C, Tylleskar T, Van de Perre P; ANRS 12174 Trial Group. Extended pre-exposure prophylaxis with lopinavir-ritonavir versus lamivudine to prevent HIV-1 transmission through breastfeeding up to 50 weeks in infants in Africa (ANRS 12174): a randomised controlled trial. Lancet. 2016 Feb 6;387(10018):566-573. doi: 10.1016/S0140-6736(15)00984-8. Epub 2015 Nov 19.
- Derived from this study: PubMed 39300364Mennecier A, Sakana BLD, D'Ottavi M, Tassembedo S, Moles JP, Kania D, Taofiki AO, Kadeba FE, Diallo I, Eymard-Duvernay S, Meda N, Mosqueira B, Fao P, Nagot N; PREVENIR-PEV Study Group; Vande Perre P. An optimized strategy triggered at the 2nd immunization visit to prevent HIV acquisition by breastfeeding: a phase 2 trial in Burkina Faso (PREVENIR-PEV). BMC Infect Dis. 2024 Sep 20;24(1):1014. doi: 10.1186/s12879-024-09910-z.
- Derived from this study: PubMed 33872801Mennecier A, Kankasa C, Fao P, Moles JP, Eymard-Duvernay S, Mwiya M, Kania D, Chunda-Liyoka C, Sakana L, Rutagwera D, Tassembedo S, Wilfred-Tonga MM, Mosqueira B, Tylleskar T, Nagot N, Van de Perre P; ANRS 12397 Study group. Design and challenges of a large HIV prevention clinical study on mother-to-child transmission: ANRS 12397 PROMISE-EPI study in Zambia and Burkina Faso. Contemp Clin Trials. 2021 Jun;105:106402. doi: 10.1016/j.cct.2021.106402. Epub 2021 Apr 17.
- Individual participant dataSharing planned: Undecided
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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.
Philippe Van de Perre, MD, PhD principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lamivudine Oral Solution in people with HIV-1, run by ANRS, Emerging Infectious Diseases at 1 site in Burkina Faso.
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 11 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 31 Mar 2022. 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 Burkina Faso. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Prevention of HIV-1 transmission from HIV-1-positive mothers to their breastfeeding children (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03869944, which also lists 3 linked publications.
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 31 Mar 2022.