HIV (Human Immunodeficiency Virus)BIKTAPREGNCT07921472
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
An observational study of HIV (Human Immunodeficiency Virus) and Pregnancy, run by Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida at 1 site in France.
Trial summary
Biktarvy® is a widely prescribed antiretroviral (ARV) medication used for the treatment of HIV-1, formulated as a single-tablet regimen. This combination therapy consists of three potent antiretroviral drugs: bictegravir (BIC/B), an integrase strand transfer inhibitor (INSTI); emtricitabine (FTC/F), a nucleoside… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV (Human Immunodeficiency Virus), Pregnancy
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 19 May 2026to 30 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Data will be collected from existing medical records at key points during pregnancy and postpartum until 6 months.
Who may be able to join
- Part 1:
- Women aged ≥18 years with documented HIV-1 infection
- Having at least one documented pregnancy during the study period
- Pregnancies with estimated conception date between January 1st 2018 and March 1st 2024
- Having received B/F/TAF for ≥30 days during pregnancy
- Having received HIV care at participating sites
Show all 9Show fewer
- Part 2:
- Receiving B/F/TAF before conception
- Demonstrated VS in first trimester (≥ 1 result of HIV-1 plasma viral load <50 copies/ml and no result ≥50 after achieving VS available before 14 weeks gestation)
Who cannot join
- Women who do not consent to having their data collected for research purposes
- Receiving B/F/TAF with other ARVs simultaneously
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Pitié-Slapêtrière
Paris, 75013
Yasmine DUDOIT, +33 142164181, yasmine.dudoit@aphp.fr
Valérie POURCHER, +33 1 42 16 02 62, valerie.martinez@aphp.fr
About this study
Official title: Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide During Pregnancy: The Retrospective Observational, Multi-site, BIKTAPREG Study
Biktarvy® is a widely prescribed antiretroviral (ARV) medication used for the treatment of HIV-1, formulated as a single-tablet regimen. This combination therapy consists of three potent antiretroviral drugs: bictegravir (BIC/B), an integrase strand transfer inhibitor (INSTI); emtricitabine (FTC/F), a nucleoside reverse transcriptase inhibitor (NRTI); and tenofovir alafenamide (TAF), the novel prodrug of tenofovir, another NRTI. This tablet (B/F/TAF) is a first-line treatment option recommended by most international guidelines for adults living with HIV. B/F/TAF is widely prescribed due to its high potency, excellent tolerability, and convenient once-daily dosing schedule.
The landscape of HIV management in pregnancy has undergone significant transformation since the mid-1990s. Guidelines for HIV screening during pregnancy, treatment of HIV-positive pregnant individuals, and the use of ARV drugs for prevention of perinatal (vertical) and postnatal HIV transmission have evolved substantially. Current guidelines recommend that pregnant women with HIV receive effective ARV therapy for maternal health and to avoid perinatal transmission; however, recommended treatment options differ in pregnancy due to concerns of toxicity, lower drug exposures, teratogenicity, or lack of information. Recently, pharmacokinetic, efficacy, and teratogenicity data have become available for B/F/TAF when used in pregnancy, and demonstrate consistently that while PK concentrations are lower, viral suppression (VS) is not affected. In response, some guidelines now list B/F/TAF as an alternative regimen to be used in pregnancy but recognize that data are still limited to make this a preferred regimen. French guidelines however, take a more conservative approach, listing BIC among drugs to avoid during pregnancy due to insufficient safety data.
Read more
Research question and objectives This retrospective multicentric, multinational observational cohort study is conducted in two distinct parts to evaluate B/F/TAF use in pregnant women with HIV-1.
Part 1: Aims to describe the patterns of B/F/TAF use in women with HIV-1 who received B/F/TAF for at least 30 days at any point during pregnancy. This will be a descriptive analysis of initiation and switch patterns among those exposed to B/F/TAF during pregnancy, and demographics/immunological/clinical characteristics. The reasons for switching B/F/TAF to other ARV treatments during pregnancy will be explored.
Part 2: Aims to describe viral, pregnancy and neonatal outcomes in a subset of women already on B/F/TAF treatment at conception with VS at the first trimester of pregnancy, and among those who continued to receive B/F/TAF through delivery, or switched to another regimen.
Read the detailed description
Study design
This observational study is designed as a multicentric retrospective cohort study conducted in two complementary parts to evaluate B/F/TAF use in pregnant women with HIV-1:
- Part 1: encompasses a descriptive analysis examining B/F/TAF utilization patterns among women who received the regimen for at least 30 days during pregnancies with estimated conception date between January 1st 2018 and March 1st 2024. This phase will document treatment initiation patterns, switching behaviors, and comprehensive demographic and clinical characteristics without conducting comparative analyses of effectiveness or safety outcomes.
- Part 2: focuses specifically on women who were receiving B/F/TAF before conception and demonstrated viral suppression during their first trimester of pregnancy. This cohort includes women who either maintained B/F/TAF through delivery or switched to alternative regimens. Data collection spans across multiple hospitals, enabling a thorough evaluation of viral, pregnancy and neonatal outcomes in real world setting.
Population This retrospective observational cohort will be conducted at HIV treatment centers and specialized obstetric units across six countries: Canada, France, Germany, Italy, Spain, and Portugal. The study is structured in two distinct parts with specific eligibility criteria.
- Conditions
- HIV (Human Immunodeficiency Virus), Pregnancy
- Keywords
- BIKTAPREG Study
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| women who received B/F/TAFfor at least 30 days during pregnancies | women who were receiving B/F/TAF before conception or during their first trimester of pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women already on B/F/TAF treatment at conception
women with HIV-1 who received B/F/TAF at any time during pregnancy
Measured: between January 1st 2018 and March 1st 2024
Proportion of women who started B/F/TAF as their first ARV regimen during pregnancy
women with HIV-1 who received B/F/TAF at any time during pregnancy
Measured: between January 1st 2018 and March 1st 2024
Proportion of women who switched-off of B/F/TAF during pregnancy
women with HIV-1 who received B/F/TAF at any time during pregnancy
Measured: between January 1st 2018 and March 1st 2024
Proportion of women who switched from other regimens to B/F/TAF during pregnancy
women with HIV-1 who received B/F/TAF at any time during pregnancy
Measured: between January 1st 2018 and March 1st 2024
Proportion of women who were on B/F/TAF at time of delivery
women with HIV-1 who received B/F/TAF at any time during pregnancy
Measured: between January 1st 2018 and March 1st 2024
Proportion of women who switched off B/F/TAF to another ARV regimen during pregnancy
women already on B/F/TAF at conception and were virologically suppressed at the first trimester of pregnancy
Measured: between January 1st 2018 and March 1st 2024
Distribution of subsequent ARV regimens among women who switched from B/F/TAF to another ARV regimen during pregnancy
women already on B/F/TAF at conception and were virologically suppressed at the first trimester of pregnancy
Measured: between January 1st 2018 and March 1st 2024
Secondary outcomes (1)
other ARV regimens from which pregnant women switched from or to B/F/TAF during pregnancy
Describe patterns of use of other ARVs beyond B/F/TAF
Measured: between January 1st 2018 and March 1st 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start19 May 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV (Human Immunodeficiency Virus)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences, San Francisco, USA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921472
- Sponsor's protocol ID
- CREPATS 22
- Other IDs
- CO-FR-380-7316
- Acronym
- BIKTAPREG
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide During Pregnancy: The Retrospective Observational, Multi-site, BIKTAPREG Study
- ClinicalTrials.gov ID
- NCT07921472
- Acronym / sponsor ID
- BIKTAPREG / CREPATS 22
- Conditions
- HIV (Human Immunodeficiency Virus), Pregnancy
- Keywords
- BIKTAPREG Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre de Recherches et d'Etude sur la Pathologie Tropicale et le SidaUniversity, hospital or other
- Collaborators
- Gilead Sciences, San Francisco, USA
- Study start
- 19 May 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 6 Nov 2026 (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.
Biktarvy® is a widely prescribed antiretroviral (ARV) medication used for the treatment of HIV-1, formulated as a single-tablet regimen. This combination therapy consists of three potent antiretroviral drugs: bictegravir (BIC/B), an integrase strand transfer inhibitor (INSTI); emtricitabine (FTC/F), a nucleoside reverse transcriptase inhibitor (NRTI); and tenofovir alafenamide (TAF), the novel prodrug of tenofovir, another NRTI. This tablet (B/F/TAF) is a first-line treatment option recommended by most international guidelines for adults living with HIV. B/F/TAF is widely prescribed due to its high potency, excellent tolerability, and convenient once-daily dosing schedule.
The landscape of HIV management in pregnancy has undergone significant transformation since the mid-1990s. Guidelines for HIV screening during pregnancy, treatment of HIV-positive pregnant individuals, and the use of ARV drugs for prevention of perinatal (vertical) and postnatal HIV transmission have evolved substantially. Current guidelines recommend that pregnant women with HIV receive effective ARV therapy for maternal health and to avoid perinatal transmission; however, recommended treatment options differ in pregnancy due to concerns of toxicity, lower drug exposures, teratogenicity, or lack of information. Recently, pharmacokinetic, efficacy, and teratogenicity data have become available for B/F/TAF when used in pregnancy, and demonstrate consistently that while PK concentrations are lower, viral suppression (VS) is not affected. In response, some guidelines now list B/F/TAF as an alternative regimen to be used in pregnancy but recognize that data are still limited to make this a preferred regimen. French guidelines however, take a more conservative approach, listing BIC among drugs to avoid during pregnancy due to insufficient safety data.
Research question and objectives This retrospective multicentric, multinational observational cohort study is conducted in two distinct parts to evaluate B/F/TAF use in pregnant women with HIV-1.
Part 1: Aims to describe the patterns of B/F/TAF use in women with HIV-1 who received B/F/TAF for at least 30 days at any point during pregnancy. This will be a descriptive analysis of initiation and switch patterns among those exposed to B/F/TAF during pregnancy, and demographics/immunological/clinical characteristics. The reasons for switching B/F/TAF to other ARV treatments during pregnancy will be explored.
Part 2: Aims to describe viral, pregnancy and neonatal outcomes in a subset of women already on B/F/TAF treatment at conception with VS at the first trimester of pregnancy, and among those who continued to receive B/F/TAF through delivery, or switched to another regimen.
Detailed description
Study design
This observational study is designed as a multicentric retrospective cohort study conducted in two complementary parts to evaluate B/F/TAF use in pregnant women with HIV-1:
- Part 1: encompasses a descriptive analysis examining B/F/TAF utilization patterns among women who received the regimen for at least 30 days during pregnancies with estimated conception date between January 1st 2018 and March 1st 2024. This phase will document treatment initiation patterns, switching behaviors, and comprehensive demographic and clinical characteristics without conducting comparative analyses of effectiveness or safety outcomes.
- Part 2: focuses specifically on women who were receiving B/F/TAF before conception and demonstrated viral suppression during their first trimester of pregnancy. This cohort includes women who either maintained B/F/TAF through delivery or switched to alternative regimens. Data collection spans across multiple hospitals, enabling a thorough evaluation of viral, pregnancy and neonatal outcomes in real world setting.
Population This retrospective observational cohort will be conducted at HIV treatment centers and specialized obstetric units across six countries: Canada, France, Germany, Italy, Spain, and Portugal. The study is structured in two distinct parts with specific eligibility criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women who received B/F/TAFfor at least 30 days during pregnancies | – | –women who were receiving B/F/TAF before conception or during their first trimester of pregnancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data will be collected from existing medical records at key points during pregnancy and postpartum until 6 months.
Key inclusion criteria (9 listed)
- Women aged ≥18 years with documented HIV-1 infection
- Having at least one documented pregnancy during the study period
- Pregnancies with estimated conception date between January 1st 2018 and March 1st 2024
- Having received B/F/TAF for ≥30 days during pregnancy
- Having received HIV care at participating sites
Key exclusion criteria (2 listed)
- Women who do not consent to having their data collected for research purposes
- Receiving B/F/TAF with other ARVs simultaneously
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of women already on B/F/TAF treatment at conception
Time frame: between January 1st 2018 and March 1st 2024
women with HIV-1 who received B/F/TAF at any time during pregnancy
Proportion of women who started B/F/TAF as their first ARV regimen during pregnancy
Time frame: between January 1st 2018 and March 1st 2024
women with HIV-1 who received B/F/TAF at any time during pregnancy
Proportion of women who switched-off of B/F/TAF during pregnancy
Time frame: between January 1st 2018 and March 1st 2024
women with HIV-1 who received B/F/TAF at any time during pregnancy
Proportion of women who switched from other regimens to B/F/TAF during pregnancy
Time frame: between January 1st 2018 and March 1st 2024
women with HIV-1 who received B/F/TAF at any time during pregnancy
Proportion of women who were on B/F/TAF at time of delivery
Time frame: between January 1st 2018 and March 1st 2024
women with HIV-1 who received B/F/TAF at any time during pregnancy
Proportion of women who switched off B/F/TAF to another ARV regimen during pregnancy
Time frame: between January 1st 2018 and March 1st 2024
women already on B/F/TAF at conception and were virologically suppressed at the first trimester of pregnancy
Distribution of subsequent ARV regimens among women who switched from B/F/TAF to another ARV regimen during pregnancy
Time frame: between January 1st 2018 and March 1st 2024
women already on B/F/TAF at conception and were virologically suppressed at the first trimester of pregnancy
1 secondary outcome
other ARV regimens from which pregnant women switched from or to B/F/TAF during pregnancy
Time frame: between January 1st 2018 and March 1st 2024
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV (Human Immunodeficiency Virus) and Pregnancy, run by Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida at 1 site in France.
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 9 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 6 Nov 2026. 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 France. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre Frange, Professor (+33 0144494961, pierre.frange@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of women already on B/F/TAF treatment at conception (time frame: between January 1st 2018 and March 1st 2024). The study lists 7 primary outcomes in all. 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 6 Nov 2026.