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

NCT06619288 | Recruiting FDA Drug

• 1 other identifier: 2024-TDF-058
• Study Type: observational
• Target: 630
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

HIV Infection

Keywords

B/F/TAF; TDF+3TC+EFV; DTG/3TC; Cohort study

Outcome Measures

Primary Outcomes (3)

• Rate of participants with virologic suppression

  Virologic suppression is defined as a plasma viral load (HIV RNA) of less than 50 copies/mL.

  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.

  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.

  At 48 weeks from the initiation of ART.

Secondary Outcomes (6)

• Rate of treatment discontinuation

  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

  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

  Assessed at baseline, and at 12, 24, and 48 weeks.

• HIV symptom assessment

  Assessed at baseline, and at 12, 24, and 48 weeks.

• Mental health assessment

  Assessed at baseline, and at 12, 24, and 48 weeks.

Other Outcomes (3)

• Change of body weight

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

• Change of LDL

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

• Change of eGFR

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

Study Arms (6)

HIV early presenters (TDF+3TC+EFV)

100 HIV-infected early presenters diagnosed between Jan 2020 and Jun 2023.

Drug: TDF+3TC+EFV

HIV late presenters (TDF+3TC+EFV)

100 HIV-infected late presenters diagnosed between Jan 2020 and Jun 2023.

Drug: TDF+3TC+EFV

HIV early presenters(DTG/3TC)

100 HIV-infected early presenters diagnosed between Jan 2020 and Jun 2023.

Drug: DTG/3TC

HIV late presenters (DTG/3TC)

100 HIV-infected late presenters diagnosed between Jan 2020 and Jun 2023.

Drug: DTG/3TC

HIV early presenters (B/F/TAF)

115 HIV-infected early presenters diagnosed between Jul 2024 and Jun 2025.

Drug: B/F/TAF

HIV late presenters (B/F/TAF)

115 HIV-infected late presenters diagnosed between Jul 2024 and Jun 2025.

Drug: B/F/TAF

Interventions

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.

HIV early presenters (B/F/TAF); HIV late presenters (B/F/TAF)

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).

HIV early presenters (TDF+3TC+EFV); HIV late presenters (TDF+3TC+EFV)

DTG/3TC DRUG

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

HIV early presenters(DTG/3TC); HIV late presenters (DTG/3TC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead
• Nantong Third Peoples Hospital: collaborator

Study Sites (1)

Nantong Third Peoples Hospital

Nantong, Jiangsu, 226006, China

RECRUITING

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Gang Qin, MD, PhD

  Affiliated Hospital of Nantong University

  STUDY CHAIR

Central Study Contacts

Gang Qin, MD, PhD

CONTACT

+86-189-1228-8106; tonygqin@ntu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 1, 2024
• Study Start: July 1, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)