HIV 1 InfectionBIKWONCT07859904
Study on Retention in Care and on Clinical Chracteristics of HIV-infected Women Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIKWO).
An observational study of HIV 1 Infection, run by Ente Ospedaliero Ospedali Galliera at 1 site in Italy.
Trial summary
Women are an underrepresented population in clinical studies on HIV and antiretroviral therapy. This study aims to help bridge this gap by providing real-world data on therapeutic management with B/F/TAF (Biktarvy) in an exclusively female cohort, aiming to improve treatment personalization and the early… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV 1 Infection
- What is being tested?
- Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF)
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 15 Dec 2026to 31 Jan 2028
- 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: HIV-1 infected women followed up at the Infectious Diseases Unit of Galliera Hospital, Genoa, Italy
Who may be able to join
- Adult women
- at least 18 years
- documented HIV-1 infection
- actively receiving treatment with BIC/FTC/TAF started between 2019 and enrollment date
- at lest 6 months follow up after starting BIC/FTC/TAF
Who cannot join
- loss to follow up before 6 months from starting BIC/FTC/TAF
- unavailability of data/information on follow up after starting BIC/FTC/TAF
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Galliera Hospital
Genova
Emanuele Pontali, +390105634470, emanuele.pontali@galliera.it
About this study
Official title: Ambispective Observational Study on Retention in Care and on Clinical Chracteristics of HIV-infected Women Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIKWO).
Women are an underrepresented population in clinical studies on HIV and antiretroviral therapy. This study aims to help bridge this gap by providing real-world data on therapeutic management with B/F/TAF (Biktarvy) in an exclusively female cohort, aiming to improve treatment personalization and the early identification of risk factors for poor retention and treatment failure in this population.
This study is single-center, ambispective observational. The retrospective component analyzes medical record data from June 2019 (the date BIC/FTC/TAF became available in Italy) to the study data cutoff. The prospective component involves data collection during routine follow-up visits up to December 31, 2027. No diagnostic or therapeutic procedures beyond standard clinical practice are involved.
Read more
The study opulation includes adult women (≥18 years of age) with a confirmed diagnosis of HIV-1 infection who have received at least one prescription for BIC/FTC/TAF at the Infectious Diseases Unit of E.O. Ospedali Galliera in Genoa from June 2019 to the present, with a documented follow-up of at least 6 months.
The primary objective of the study is to determine the 12- and 24-month retention-in-care rates among women treated with B/F/TAF (Biktarvy) and to identify factors associated with treatment maintenance and predictors of treatment discontinuation.
Secondary objectives of the study include:
- Percentage of women achieving/maintaining virologic suppression (<50 copies/mL) at 12 and 24 months during B/F/TAF treatment
- Evaluation of treatment persistence with B/F/TAF across different age groups
- Analysis of reasons for discontinuing B/F/TAF (adverse events, patient choice, planned switch, other)
- Identification of factors associated with virologic failure during B/F/TAF therapy
- Evaluation of the impact of menopausal status (pre- vs. post-menopause) on retention and virologic outcomes
- Analysis of the effect of the menopausal transition during follow-up on outcomes
- Correlation of past virologic history (nadir CD4, peak viremia, previous failures) with outcomes
- Evaluation of the impact of prior antiretroviral treatment history (previous lines, drug classes used, documented resistance)
- Analysis of demographic and socioeconomic variables associated with treatment persistence and virologic success
- Conditions
- HIV 1 Infection
- Being tested
- Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF)
- Keywords
- hiv, bictegravir, women
- 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.
Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF)Drug
Evaluation of retention in care and description of clinical characteristics of HIV-infected women treated with Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF).
Most published studies treatment of women with Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF) recruited very few women and focused on efficacy and safety. This study focuses on partecipants' characteristcs and their interaction with retention in care
| Study group | Role | What they receive |
|---|---|---|
| HIV-infeted women | Not described Receives: Drug: Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in care rate
Measured: January 2019-December 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start15 Dec 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV 1 InfectionStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ente Ospedaliero Ospedali Galliera
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859904
- Sponsor's protocol ID
- EOOspedaliGalliera
- Acronym
- BIKWO
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It depends on interest on study findings from other reasearchers
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambispective Observational Study on Retention in Care and on Clinical Chracteristics of HIV-infected Women Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIKWO).
- ClinicalTrials.gov ID
- NCT07859904
- Acronym / sponsor ID
- BIKWO / EOOspedaliGalliera
- Conditions
- HIV 1 Infection
- Keywords
- hiv, bictegravir, women
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ente Ospedaliero Ospedali GallieraUniversity, hospital or other
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 6 Oct 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.
Women are an underrepresented population in clinical studies on HIV and antiretroviral therapy. This study aims to help bridge this gap by providing real-world data on therapeutic management with B/F/TAF (Biktarvy) in an exclusively female cohort, aiming to improve treatment personalization and the early identification of risk factors for poor retention and treatment failure in this population.
This study is single-center, ambispective observational. The retrospective component analyzes medical record data from June 2019 (the date BIC/FTC/TAF became available in Italy) to the study data cutoff. The prospective component involves data collection during routine follow-up visits up to December 31, 2027. No diagnostic or therapeutic procedures beyond standard clinical practice are involved.
The study opulation includes adult women (≥18 years of age) with a confirmed diagnosis of HIV-1 infection who have received at least one prescription for BIC/FTC/TAF at the Infectious Diseases Unit of E.O. Ospedali Galliera in Genoa from June 2019 to the present, with a documented follow-up of at least 6 months.
The primary objective of the study is to determine the 12- and 24-month retention-in-care rates among women treated with B/F/TAF (Biktarvy) and to identify factors associated with treatment maintenance and predictors of treatment discontinuation.
Secondary objectives of the study include:
- Percentage of women achieving/maintaining virologic suppression (<50 copies/mL) at 12 and 24 months during B/F/TAF treatment
- Evaluation of treatment persistence with B/F/TAF across different age groups
- Analysis of reasons for discontinuing B/F/TAF (adverse events, patient choice, planned switch, other)
- Identification of factors associated with virologic failure during B/F/TAF therapy
- Evaluation of the impact of menopausal status (pre- vs. post-menopause) on retention and virologic outcomes
- Analysis of the effect of the menopausal transition during follow-up on outcomes
- Correlation of past virologic history (nadir CD4, peak viremia, previous failures) with outcomes
- Evaluation of the impact of prior antiretroviral treatment history (previous lines, drug classes used, documented resistance)
- Analysis of demographic and socioeconomic variables associated with treatment persistence and virologic success
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-infeted women | – | Drug: Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-1 infected women followed up at the Infectious Diseases Unit of Galliera Hospital, Genoa, Italy
Key inclusion criteria (5 listed)
- Adult women
- at least 18 years
- documented HIV-1 infection
- actively receiving treatment with BIC/FTC/TAF started between 2019 and enrollment date
- at lest 6 months follow up after starting BIC/FTC/TAF
Key exclusion criteria (2 listed)
- loss to follow up before 6 months from starting BIC/FTC/TAF
- unavailability of data/information on follow up after starting BIC/FTC/TAF
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 |
|---|---|---|
| Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF)Evaluation of retention in care and description of clinical characteristics of HIV-infected women treated with Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF). Most published studies treatment of women with Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF) recruited very few women and focused on efficacy and safety. This study focuses on partecipants' characteristcs and their interaction with retention in care | Drug | HIV-infeted women |
Primary outcome
Retention in care rate
Time frame: January 2019-December 2027
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 9 Oct 2026.
- Individual participant dataSharing planned: Undecided. It depends on interest on study findings from other reasearchers
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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 1 Infection, run by Ente Ospedaliero Ospedali Galliera at 1 site in Italy.
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 5 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: opening soon, as of the sponsor's last update on 9 Oct 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 Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention in care rate (time frame: January 2019-December 2027). 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 9 Oct 2026.