HIV-1-infectionPhase 4NCT04296695
Biktarvy in Treatment-Naïve Late Presenters With HIV-1 Infection
A Phase 4 study testing B/F/TAF and TDF/3TC/EFV in people with HIV-1-infection, run by Peking Union Medical College Hospital at 5 sites in China.
Trial summary
The efficacy and safety of Biktarvy in Treatment-Naïve Late Presenters with HIV-1 Infection Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- B/F/TAF and TDF/3TC/EFV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 5 sitesChina
- Study dates
- 14 Jul 2021to 6 Jun 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Ability to understand and sign a written informed consent form 2.18 years old or older 3.Confirmed HIV-antibody positive through Western Blot testing without any previous ART 4.CD4 < 200/mm3, VL >1000 copies/ml 5.Estimated glomerular filtration rate (GFR) ≥ 50 mL/min (calculated by CKD-EPI) 6.Clinical status relatively stable 7.Females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually from screening throughout the duration of study treatment and for 30 days following the last dose of study drug.
Who cannot join
- A new AIDS-defining condition diagnosed within the 30 days prior to screening
- Participants experiencing severe organ lesion.
- Positive serum pregnancy test or planned to be pregnant.
- Females who are breastfeeding
- With carcinoma
- Concomitant medication of immunosuppression or chemoradiotherapy
Show all 9Show fewer
- Participation in any other interventional clinical trial
- Screening stage find: Hb < 9g/dL, WBC < 3000/ul. neutrophilic granulocyte< 1500/ul, PLT< 75000/ul. Scr > 1.5 ULN,Hepatic transaminases (AST and ALT) and ALP > 3 × ULN,total bilirubin ≤ 2 x ULN.
- Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
China Liaoning Dalian Public Health Clinical Center
Dalian, Liaoning
Lanzhou Feike Hospital
Lanzhou, Guansu
The Guangxi Zhuang Autonomous Region Longtan Hospital
Liuzhou, Guangxi, 545005
The Second Hospital of Nanjing
Najing, Jiangsu, 210003
Tianjin Second People's Hospital
Tianjin, 300192
About this study
Official title: The Efficacy and Safety of Biktarvy in Treatment-Naïve Late Presenters With HIV-1 Infection
The efficacy and safety of Biktarvy in Treatment-Naïve Late Presenters with HIV-1 Infection
Read the detailed description
HIV epidemic is still severe in China, the estimated number if PLWH in HIV is around 1.25 million all of China with an increasing trend of new cases. Late presenters with low CD4 T cells and/or with hight viral load should be paid more attention for better treatment and care. As a new combined antiretroviral regimen of integrase inhibitor, B/F/TAF was recently approved in US and European and also in China which needs more real world data in China. Non-inferiority or advantage of B/F/TAF comparing with the first line TDF/3TC/EFV for later presenters in China needs to be explored.
- Conditions
- HIV-1-infection
- Being tested
- B/F/TAF, TDF/3TC/EFV
- Keywords
- Biktarvy, HIV-1 infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B/F/TAFDrug
Also called Biktarvy
randomized, multicentered, open-lable RCT, one arm with B/F/TAF and one arm with TDF/3TC/EFV
TDF/3TC/EFVDrug
Also called Tenofovir /Ravmidine /Efavirenz
TDF/3TC/EFV
| Study group | Role | What they receive |
|---|---|---|
| B/F/TAF | Experimental | 50mg/600mg/300mg Receives: Drug: B/F/TAF |
| TDF/3TC/EFV | Active comparator | 300mg/300mg/400mg Receives: Drug: TDF/3TC/EFV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with HIV-1 RNA < 50 copies/mL at Weeks 12
Proportion of participants with HIV-1 RNA < 50 copies/mL at Weeks 12
Measured: Weeks 12
Secondary outcomes (3)
Proportion of participants with HIV-1 RNA < 50 copies/mL at Weeks 4,24,48
Proportion of participants with HIV-1 RNA < 50 copies/mL at Weeks 4,24,48
Measured: Weeks 4,24,48
The Change in CD4 T cell count from baseline at Weeks 12,24,48
The Change in CD4 T cell count from baseline at Weeks 12,24,48
Measured: Weeks 12,24,48
Change in CD4/CD8 ratio from baseline at Weeks 12,24,48
Change in CD4/CD8 ratio from baseline at Weeks 12,24,48
Measured: Weeks 12,24,48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start14 Jul 2021
- Primary completion13 Dec 2022
- Study completion6 Jun 2025
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.
- More trials run by Peking Union Medical College HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-inferioty or advantage of B/F/TAF comparing with the first line TDF/3TC/EFV for later presenters in China
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Wei LYU, Peking Union Medical College Hospital
- Investigators
- Wei Lyu, Principal investigator, Department of Infectious Diseases, PekingUMCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296695
- Sponsor's protocol ID
- Gilead ISR-CN-18-10596
- Status last verified
- Jun 2026
- First submitted
- 3 Mar 2020
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Biktarvy in Treatment-Naïve Late Presenters With HIV-1 Infection
- ClinicalTrials.gov ID
- NCT04296695
- Acronym / sponsor ID
- Gilead ISR-CN-18-10596
- Conditions
- HIV-1-infection
- Keywords
- Biktarvy, HIV-1 infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 6 Jun 2025 (actual)
- First posted
- 5 Mar 2020 (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 efficacy and safety of Biktarvy in Treatment-Naïve Late Presenters with HIV-1 Infection
Detailed description
HIV epidemic is still severe in China, the estimated number if PLWH in HIV is around 1.25 million all of China with an increasing trend of new cases. Late presenters with low CD4 T cells and/or with hight viral load should be paid more attention for better treatment and care. As a new combined antiretroviral regimen of integrase inhibitor, B/F/TAF was recently approved in US and European and also in China which needs more real world data in China. Non-inferiority or advantage of B/F/TAF comparing with the first line TDF/3TC/EFV for later presenters in China needs to be explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-inferioty or advantage of B/F/TAF comparing with the first line TDF/3TC/EFV for later presenters in China
| Arm | Type | Receives |
|---|---|---|
| B/F/TAF | Experimental | Drug: B/F/TAF50mg/600mg/300mg |
| TDF/3TC/EFV | Active comparator | Drug: TDF/3TC/EFV300mg/300mg/400mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.Ability to understand and sign a written informed consent form 2.18 years old or older 3.Confirmed HIV-antibody positive through Western Blot testing without any previous ART 4.CD4 < 200/mm3, VL >1000 copies/ml 5.Estimated glomerular filtration rate (GFR) ≥ 50 mL/min (calculated by CKD-EPI) 6.Clinical status relatively stable 7.Females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually from screening throughout the duration of study treatment and for 30 days following the last dose of study drug.
Key exclusion criteria (9 listed)
- A new AIDS-defining condition diagnosed within the 30 days prior to screening
- Participants experiencing severe organ lesion.
- Positive serum pregnancy test or planned to be pregnant.
- Females who are breastfeeding
- With carcinoma
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 |
|---|---|---|
| B/F/TAFAlso: Biktarvyrandomized, multicentered, open-lable RCT, one arm with B/F/TAF and one arm with TDF/3TC/EFV | Drug | B/F/TAF |
| TDF/3TC/EFVAlso: Tenofovir /Ravmidine /EfavirenzTDF/3TC/EFV | Drug | TDF/3TC/EFV |
Primary outcome
Proportion of participants with HIV-1 RNA < 50 copies/mL at Weeks 12
Time frame: Weeks 12
Proportion of participants with HIV-1 RNA < 50 copies/mL at Weeks 12
3 secondary outcomes
Proportion of participants with HIV-1 RNA < 50 copies/mL at Weeks 4,24,48
Time frame: Weeks 4,24,48
The Change in CD4 T cell count from baseline at Weeks 12,24,48
Time frame: Weeks 12,24,48
Change in CD4/CD8 ratio from baseline at Weeks 12,24,48
Time frame: Weeks 12,24,48
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 5 Jun 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. This study is not recruiting at the moment.
Wei Lyu principal investigator
Department of Infectious Diseases, PekingUMCH
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing B/F/TAF and TDF/3TC/EFV in people with HIV-1-infection, run by Peking Union Medical College Hospital at 5 sites in China.
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 1 inclusion and 9 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 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. 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 participants with HIV-1 RNA < 50 copies/mL at Weeks 12 (time frame: Weeks 12). 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 5 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.