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NCT Number: NCT06619288

Good-first: B/F/TAF As First-line ART

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.

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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantong Third Peoples Hospital

Nantong, Jiangsu, 226006, China

Location status: Recruiting

Location contact

Mei-Yin Zou, MD

CONTACT

[email protected]

+86-159-5082-4526

Mei-Yin Zou, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • Severe renal impairment (creatinine clearance < 50 mL/min).
  • Hepatitis B co-infection or severe hepatic impairment (Child-Pugh Class C).
  • Active tuberculosis (TB).

Treatment and study plan

B/F/TAF

Drug

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+EFV

Drug

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/3TC

Drug

Take one tablet per dose, once daily. Each tablet contains dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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.

  3. QoL assessment

    Time frame: Assessed at baseline, and at 12, 24, and 48 weeks.

    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.

  4. HIV symptom assessment

    Time frame: Assessed at baseline, and at 12, 24, and 48 weeks.

    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.

  5. Mental health assessment

    Time frame: Assessed at baseline, and at 12, 24, and 48 weeks.

    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.

  6. Cardiovascular risk assessment

    Time frame: Assessed at baseline, and at 12, 24, and 48 weeks.

    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.

Other outcomes

  1. Change of body weight

    Time frame: At 12 weeks, 24 weeks and 48 weeks from the initiation of ART.

    This metric represents the percentage change in body weight from the baseline measurement.

  2. Change of LDL

    Time frame: At 12 weeks, 24 weeks and 48 weeks from the initiation of ART.

    Monitoring changes in low-density lipoprotein (LDL) cholesterol levels helps assess cardiovascular risk and the impact of ART on lipid profiles over time.

  3. Change of eGFR

    Time frame: At 12 weeks, 24 weeks and 48 weeks from the initiation of ART.

    Estimated glomerular filtration rate (eGFR) calculated using serum creatinine levels is used to assess kidney function over time and indicates how well the kidneys are filtering waste from the blood. Changes in eGFR can signal improvements or declines in renal function.

Study contacts

Contact information is provided by the study sponsor or research team.

Gang Qin, MD, PhD

CONTACT

[email protected]

+86-189-1228-8106

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Nantong University

Other

Collaborators

  • Nantong Third Peoples Hospital

Registry information

Official study title

Good-first: a Multicohort Study of B/F/TAF As First-line ART in a Public Hospital in Eastern China

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 1, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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