Biktarvy in Treatment-Naïve Late Presenters With HIV-1 Infection (NCT04296695) | Clinical Trial Compass
CompletedPhase 4
Biktarvy in Treatment-Naïve Late Presenters With HIV-1 Infection
China202 participantsStarted 2021-07-14
Plain-language summary
The efficacy and safety of Biktarvy in Treatment-Naïve Late Presenters with HIV-1 Infection
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
.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
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial has already been completed, has the data been published, and what did it show about how quickly Biktarvy brought HIV-1 RNA below 50 copies/mL in people who were diagnosed late — like I might be?
2This study focused specifically on 'late presenters' — people diagnosed at a more advanced stage of HIV — so does my current CD4 count or viral load put me in a similar category, and would Biktarvy still be the right choice for me?
3The trial measured viral suppression at just 12 weeks, which is a relatively short window — what do the longer-term results or other studies tell us about staying on Biktarvy beyond that point?
4Since this is a Phase 4 trial, meaning Biktarvy was already approved before this study, does that change how confident you are in its safety profile compared to other first-line HIV treatments you might recommend for me?
5Are there any standard treatment alternatives to Biktarvy that I should consider alongside what this trial found, especially given my specific health situation at diagnosis?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of participants with HIV-1 RNA < 50 copies/mL at Weeks 12