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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-14

Study Completion Date

2023-12-31

Brief Summary

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

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Detailed Description

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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

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HIV-1-infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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

Study Groups

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B/F/TAF

50mg/600mg/300mg

Group Type EXPERIMENTAL

B/F/TAF

Intervention Type DRUG

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

TDF/3TC/EFV

300mg/300mg/400mg

Group Type ACTIVE_COMPARATOR

TDF/3TC/EFV

Intervention Type DRUG

TDF/3TC/EFV

Interventions

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B/F/TAF

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

Intervention Type DRUG

TDF/3TC/EFV

Intervention Type DRUG

Other Intervention Names

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Biktarvy Tenofovir /Ravmidine /Efavirenz

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

1. A new AIDS-defining condition diagnosed within the 30 days prior to screening
2. Participants experiencing severe organ lesion.
3. Positive serum pregnancy test or planned to be pregnant.
4. Females who are breastfeeding
5. With carcinoma
6. Concomitant medication of immunosuppression or chemoradiotherapy
7. Participation in any other interventional clinical trial
8. 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.
9. 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No