HIV InfectionNCT06619288
Good-first: B/F/TAF As First-line ART
An observational study of HIV Infection, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
This is a multicohort study conducted at Affiliated Hospital of Nantong University, and Nantong Third Peoples Hospital (Designated Hospital for HIV/AIDS Treatment of Nantong City), China. The study would involve 630 patients initiating HIV treatment, divided into six cohorts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- B/F/TAF, TDF+3TC+EFV and DTG/3TC
- Type of treatment
- Pill or oral medicine
- How many people
- 630 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 30 Jun 2026
- Phase
- Observational
- 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
Study population: The study population will consist of HIV-infected patients, including those who present in the early stages of infection as well as those with late-stage or advanced presentations. These individuals will encompass a wide range of clinical scenarios to ensure the findings are applicable to diverse patient populations.
Who may be able to join
- Adults (≥18 years) diagnosed with HIV/AIDS, ART-naive, from July 2024 to June 2025 (prospective) or January 2020 to June 2023 (retrospective).
- Eligible for ART initiation with B/F/TAF or previously treated with TDF+3TC+EFV or DTG/3TC.
- Willing to adhere to study procedures and follow-up visits or have complete electronic health records (EHRs).
Who cannot join
- Severe renal impairment (creatinine clearance \< 50 mL/min).
- Hepatitis B co-infection or severe hepatic impairment (Child-Pugh Class C).
- Active tuberculosis (TB).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nantong Third Peoples Hospital
Nantong, Jiangsu, 226006
Mei-Yin Zou, MD, +86-159-5082-4526, zoumeiyin@126.com
Mei-Yin Zou, MD
About this study
Official title: Good-first: a Multicohort Study of B/F/TAF As First-line ART in a Public Hospital in Eastern China
This is a multicohort study conducted at Affiliated Hospital of Nantong University, and Nantong Third Peoples Hospital (Designated Hospital for HIV/AIDS Treatment of Nantong City), China. The study would involve 630 patients initiating HIV treatment, divided into six cohorts. The enrollment period for the prospective cohort is from July 2024 to June 2025, while the enrollment period for the retrospective cohort is from January 2020 to June 2023.
Read the detailed description
Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is recommended for initiating antiretroviral therapy (ART) in newly diagnosed HIV patients, including those with advanced disease. However, clinical data for this group is limited, and the high cost of B/F/TAF may hinder its widespread use as a first-line treatment.
This study aim to gather real-world evidence on the clinical practice of B/F/TAF as a first-line ART and address the knowledge gap regarding its cost-effectiveness. A multicohort study at the Designated Hospital for HIV/AIDS Treatment of Nantong City, China, involves 630 patients initiating HIV treatment, divided into six cohorts. There are 230 prospective patients on B/F/TAF (115 late presenters with CD4; 350 cells/μL or an AIDS-defining event, and 115 early presenters). Additionally, there are 400 retrospective patients on either tenofovir+lamivudine+efavirenz (TDF+3TC+EFV, 100 for each presentation group) or dolutegravir/lamivudine (DTG/3TC, 100 for each presentation group). The enrollment period for the prospective cohort is from July 2024 to June 2025, while the enrollment period for the retrospective cohort is from January 2020 to June 2023.
Data will be collected at baseline and at specific intervals over 48 weeks using electronic health records and patient-reported outcomes. Clinical data include time from diagnosis to ART initiation, plasma viral load (VL), CD4 count, adverse events, treatment adherence, and quality of life (QoL). QoL improvements will be assessed through questionnaires. Cost data will be collected following healthcare reporting standards. A microsimulation model will be adapted. The cost-effectiveness of B/F/TAF, compared to the other regimens, will be evaluated using clinical cohort data and modeling techniques to project long-term economic outcomes.
This study was approved by the ethics committee of Nantong Third Peoples Hospital. Consent will also be obtained from the participants during the study process.
This study followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline for cohort studies.
- Conditions
- HIV Infection
- Being tested
- B/F/TAF, TDF+3TC+EFV, DTG/3TC
- Keywords
- B/F/TAF, TDF+3TC+EFV, DTG/3TC, Cohort study
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B/F/TAFDrug
Take one tablet per dose, once daily. Each tablet contains bictegravir (BIC) 50 mg, emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 25 mg.
TDF+3TC+EFVDrug
Take five tablets per dose, once daily. Each dose contains one tablet of tenofovir (TDF) 300 mg, one tablet of lamivudine (3TC) 300 mg, and three tablets of efavirenz (EFV) 200 mg (totaling 600 mg).
DTG/3TCDrug
Take one tablet per dose, once daily. Each tablet contains dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg.
| Study group | Role | What they receive |
|---|---|---|
| HIV early presenters (TDF+3TC+EFV) | 100 HIV-infected early presenters diagnosed between Jan 2020 and Jun 2023. Receives: Drug: TDF+3TC+EFV | |
| HIV late presenters (TDF+3TC+EFV) | 100 HIV-infected late presenters diagnosed between Jan 2020 and Jun 2023. Receives: Drug: TDF+3TC+EFV | |
| HIV early presenters(DTG/3TC) | 100 HIV-infected early presenters diagnosed between Jan 2020 and Jun 2023. Receives: Drug: DTG/3TC | |
| HIV late presenters (DTG/3TC) | 100 HIV-infected late presenters diagnosed between Jan 2020 and Jun 2023. Receives: Drug: DTG/3TC | |
| HIV early presenters (B/F/TAF) | 115 HIV-infected early presenters diagnosed between Jul 2024 and Jun 2025. Receives: Drug: B/F/TAF | |
| HIV late presenters (B/F/TAF) | 115 HIV-infected late presenters diagnosed between Jul 2024 and Jun 2025. Receives: Drug: B/F/TAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of participants with virologic suppression
Virologic suppression is defined as a plasma viral load (HIV RNA) of less than 50 copies/mL.
Measured: At 12 weeks, 24 weeks, and 48 weeks from the initiation of ART.
Change of CD4 count
The percentage change in CD4+ T cell count from baseline after initiating ART, stratified by patients with lower versus higher baseline CD4+ levels.
Measured: At 12 weeks, 24 weeks, and 48 weeks from the initiation of ART.
Rate of immune reconstitution in late presenters
Immune reconstitution is defined as an immunological response in HIV late presenters, characterized by a CD4+ T cell count increase of at least 20% from baseline or reaching at least 350 cells/μL at 48 weeks, accompanied by an undetectable viral load.
Measured: At 48 weeks from the initiation of ART.
Secondary outcomes (6)
Rate of treatment discontinuation
Throughout the entire follow-up period, there were instances of loss to follow-up or death due to other illnesses. If a subject experiences significant adverse reactions after taking the medication, it is necessary to discontinue the medication.
Measured: From the initiation of ART until the end of the study, with an estimated period of assessment up to 104 weeks. This period includes monitoring from the date of ART initiation until the date of treatment discontinuation or study end.
Number of adverse events
Adverse events are mainly divided into five categories: central nervous system symptoms, which include headache, dizziness, insomnia, difficulty concentrating, mood changes, or mental confusion; gastrointestinal symptoms, such as nausea, vomiting, diarrhea, abdominal pain, or dyspepsia; hematologic symptoms, which involve low levels of red blood cells or hemoglobin, leading to fatigue, weakness, or pallor; hepatotoxicity, indicated by elevated liver enzyme levels, jaundice, or other signs of liver dysfunction; and dermatitis, which includes rash, itching, erythema, or dry skin.
Measured: From the initiation of ART until the end of the study, with an estimated period of assessment up to 104 weeks. This period includes monitoring from the date of ART initiation until the date of treatment discontinuation or study end.
QoL assessment
Quality of Life (QoL) is assessed using the EQ-5D-5L scale, a standardized instrument developed by the EuroQol Group. It measures general health across five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with five levels of severity each. The index score ranges from -0.59 to 1, with higher scores indicating better health status.
Measured: Assessed at baseline, and at 12, 24, and 48 weeks.
HIV symptom assessment
The HIV Symptom Index (HIV-SI) is used to assess the prevalence and severity of HIV-related symptoms. Scores range from 0 to 80, with higher scores indicating a greater burden of symptoms.
Measured: Assessed at baseline, and at 12, 24, and 48 weeks.
Mental health assessment
People living with HIV (PLHIV) have a risk of experiencing depressive symptoms that is three times higher than that of the general population. The Patient Health Questionnaire-9 (PHQ-9), a self-administered scale, is used for diagnosing and monitoring depression. Scores on the PHQ-9 range from 0 to 27, with higher scores indicating more severe levels of depression. If a patient presents with moderate depressive symptoms (PHQ-9 score \> 9), he or she will be referred to a psychiatrist.
Measured: Assessed at baseline, and at 12, 24, and 48 weeks.
Cardiovascular risk assessment
Cardiovascular risk assessment is an essential component of clinical practice for people living with HIV (PLHIV). The Framingham Risk Score is used to estimate the 10-year cardiovascular risk of an individual. Scores range from 0% to 30% or higher, with higher scores indicating a greater cardiovascular risk.
Measured: Assessed at baseline, and at 12, 24, and 48 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Jul 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Collaborators
- Nantong Third Peoples Hospital
- Responsible party
- Principal investigator, Gang Qin, MD, PhD, Affiliated Hospital of Nantong University
- Investigators
- Gang Qin, MD, PhD, Study chair, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619288
- Sponsor's protocol ID
- 2024-TDF-058
- Status last verified
- Sep 2024
- First submitted
- 24 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Good-first: a Multicohort Study of B/F/TAF As First-line ART in a Public Hospital in Eastern China
- ClinicalTrials.gov ID
- NCT06619288
- Acronym / sponsor ID
- 2024-TDF-058
- Conditions
- HIV Infection
- Keywords
- B/F/TAF, TDF+3TC+EFV, DTG/3TC, Cohort study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 630 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Collaborators
- Nantong Third Peoples Hospital
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 1 Oct 2024 (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.
This is a multicohort study conducted at Affiliated Hospital of Nantong University, and Nantong Third Peoples Hospital (Designated Hospital for HIV/AIDS Treatment of Nantong City), China. The study would involve 630 patients initiating HIV treatment, divided into six cohorts. The enrollment period for the prospective cohort is from July 2024 to June 2025, while the enrollment period for the retrospective cohort is from January 2020 to June 2023.
Detailed description
Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is recommended for initiating antiretroviral therapy (ART) in newly diagnosed HIV patients, including those with advanced disease. However, clinical data for this group is limited, and the high cost of B/F/TAF may hinder its widespread use as a first-line treatment.
This study aim to gather real-world evidence on the clinical practice of B/F/TAF as a first-line ART and address the knowledge gap regarding its cost-effectiveness. A multicohort study at the Designated Hospital for HIV/AIDS Treatment of Nantong City, China, involves 630 patients initiating HIV treatment, divided into six cohorts. There are 230 prospective patients on B/F/TAF (115 late presenters with CD4; 350 cells/μL or an AIDS-defining event, and 115 early presenters). Additionally, there are 400 retrospective patients on either tenofovir+lamivudine+efavirenz (TDF+3TC+EFV, 100 for each presentation group) or dolutegravir/lamivudine (DTG/3TC, 100 for each presentation group). The enrollment period for the prospective cohort is from July 2024 to June 2025, while the enrollment period for the retrospective cohort is from January 2020 to June 2023.
Data will be collected at baseline and at specific intervals over 48 weeks using electronic health records and patient-reported outcomes. Clinical data include time from diagnosis to ART initiation, plasma viral load (VL), CD4 count, adverse events, treatment adherence, and quality of life (QoL). QoL improvements will be assessed through questionnaires. Cost data will be collected following healthcare reporting standards. A microsimulation model will be adapted. The cost-effectiveness of B/F/TAF, compared to the other regimens, will be evaluated using clinical cohort data and modeling techniques to project long-term economic outcomes.
This study was approved by the ethics committee of Nantong Third Peoples Hospital. Consent will also be obtained from the participants during the study process.
This study followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline for cohort studies.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| HIV early presenters (TDF+3TC+EFV) | – | Drug: TDF+3TC+EFV100 HIV-infected early presenters diagnosed between Jan 2020 and Jun 2023. |
| HIV late presenters (TDF+3TC+EFV) | – | Drug: TDF+3TC+EFV100 HIV-infected late presenters diagnosed between Jan 2020 and Jun 2023. |
| HIV early presenters(DTG/3TC) | – | Drug: DTG/3TC100 HIV-infected early presenters diagnosed between Jan 2020 and Jun 2023. |
| HIV late presenters (DTG/3TC) | – | Drug: DTG/3TC100 HIV-infected late presenters diagnosed between Jan 2020 and Jun 2023. |
| HIV early presenters (B/F/TAF) | – | Drug: B/F/TAF115 HIV-infected early presenters diagnosed between Jul 2024 and Jun 2025. |
| HIV late presenters (B/F/TAF) | – | Drug: B/F/TAF115 HIV-infected late presenters diagnosed between Jul 2024 and Jun 2025. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of HIV-infected patients, including those who present in the early stages of infection as well as those with late-stage or advanced presentations. These individuals will encompass a wide range of clinical scenarios to ensure the findings are applicable to diverse patient populations.
Key inclusion criteria (3 listed)
- Adults (≥18 years) diagnosed with HIV/AIDS, ART-naive, from July 2024 to June 2025 (prospective) or January 2020 to June 2023 (retrospective).
- Eligible for ART initiation with B/F/TAF or previously treated with TDF+3TC+EFV or DTG/3TC.
- Willing to adhere to study procedures and follow-up visits or have complete electronic health records (EHRs).
Key exclusion criteria (3 listed)
- Severe renal impairment (creatinine clearance \< 50 mL/min).
- Hepatitis B co-infection or severe hepatic impairment (Child-Pugh Class C).
- Active tuberculosis (TB).
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/TAFTake one tablet per dose, once daily. Each tablet contains bictegravir (BIC) 50 mg, emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 25 mg. | Drug | HIV early presenters (B/F/TAF), HIV late presenters (B/F/TAF) |
| TDF+3TC+EFVTake five tablets per dose, once daily. Each dose contains one tablet of tenofovir (TDF) 300 mg, one tablet of lamivudine (3TC) 300 mg, and three tablets of efavirenz (EFV) 200 mg (totaling 600 mg). | Drug | HIV early presenters (TDF+3TC+EFV), HIV late presenters (TDF+3TC+EFV) |
| DTG/3TCTake one tablet per dose, once daily. Each tablet contains dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg. | Drug | HIV early presenters(DTG/3TC), HIV late presenters (DTG/3TC) |
Primary outcome
Rate of participants with virologic suppression
Time frame: At 12 weeks, 24 weeks, and 48 weeks from the initiation of ART.
Virologic suppression is defined as a plasma viral load (HIV RNA) of less than 50 copies/mL.
Change of CD4 count
Time frame: At 12 weeks, 24 weeks, and 48 weeks from the initiation of ART.
The percentage change in CD4+ T cell count from baseline after initiating ART, stratified by patients with lower versus higher baseline CD4+ levels.
Rate of immune reconstitution in late presenters
Time frame: At 48 weeks from the initiation of ART.
Immune reconstitution is defined as an immunological response in HIV late presenters, characterized by a CD4+ T cell count increase of at least 20% from baseline or reaching at least 350 cells/μL at 48 weeks, accompanied by an undetectable viral load.
6 secondary outcomes
Rate of treatment discontinuation
Time frame: From the initiation of ART until the end of the study, with an estimated period of assessment up to 104 weeks. This period includes monitoring from the date of ART initiation until the date of treatment discontinuation or study end.
Number of adverse events
Time frame: From the initiation of ART until the end of the study, with an estimated period of assessment up to 104 weeks. This period includes monitoring from the date of ART initiation until the date of treatment discontinuation or study end.
QoL assessment
Time frame: Assessed at baseline, and at 12, 24, and 48 weeks.
HIV symptom assessment
Time frame: Assessed at baseline, and at 12, 24, and 48 weeks.
Mental health assessment
Time frame: Assessed at baseline, and at 12, 24, and 48 weeks.
Cardiovascular risk assessment
Time frame: Assessed at baseline, and at 12, 24, and 48 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- 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.
Gang Qin, MD, PhD study chair
Affiliated Hospital of Nantong University
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 Infection, run by Affiliated Hospital of Nantong University at 1 site 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 3 inclusion and 3 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 1 Oct 2024. 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 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.
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?
Contact Gang Qin, MD, PhD (+86-189-1228-8106, tonygqin@ntu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of participants with virologic suppression (time frame: At 12 weeks, 24 weeks, and 48 weeks from the initiation of ART.). The study lists 3 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 1 Oct 2024.