Biktarvy in Treatment-Naïve Late Presenters With HIV-1 Infection

NCT04296695 | Unknown Phase 4 FDA Drug

• 1 other identifier: Gilead ISR-CN-18-10596
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 3

Brief Summary

The efficacy and safety of Biktarvy in Treatment-Naïve Late Presenters with HIV-1 Infection

Conditions

HIV-1-infection

Keywords

Biktarvy; HIV-1 infection

Outcome Measures

Primary Outcomes (2)

• Proportion of participants with HIV-1 RNA

  Proportion of participants with HIV-1 RNA

  base line,Weeks 12,24 and 48

• The Change in CD4 T cell count from baseline

  The Change in CD4 T cell count from baseline

  base line,Weeks 12, 24 and 48

Study Arms (2)

B/F/TAF

EXPERIMENTAL

50mg/600mg/300mg

Drug: B/F/TAF

TDF/3TC/EFV

ACTIVE COMPARATOR

300mg/300mg/400mg

Drug: TDF/3TC/EFV

Interventions

B/F/TAF DRUG

randomized, multicentered, open-lable RCT, one arm with B/F/TAF and one arm with TDF/3TC/EFV

Also known as: Biktarvy

B/F/TAF

TDF/3TC/EFV DRUG

TDF/3TC/EFV

Also known as: Tenofovir /Ravmidine /Efavirenz

TDF/3TC/EFV

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Gilead Sciences: collaborator

Study Sites (3)

The Guangxi Zhuang Autonomous Region Longtan Hospital

Liuchow, Guangxi, 545005, China

Location

The Second Hospital of Nanjing

Najing, Jiangsu, 210003, China

Location

Tianjin Second People's Hospital

Tianjin, 300192, China

Location

MeSH Terms

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination; Tenofovir; efavirenz

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Wei Lyu

  Department of Infectious Diseases, PekingUMCH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: randomized, multicentered, open-lable RCT, one arm with B/F/TAF and one arm with TDF/3TC/EFV
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-inferioty or advantage of B/F/TAF comparing with the first line TDF/3TC/EFV for later presenters in China

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 5, 2020
• Study Start: July 14, 2021
• Primary Completion: December 13, 2022
• Study Completion: December 31, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

CN (3)