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Can biktarvy help Late-Stage HIV patients catch up?

NCT ID NCT04296695

Disease control Sponsor: Peking Union Medical College Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This completed Phase 4 trial tested the HIV drug Biktarvy in 202 people who were newly diagnosed with HIV and had low CD4 counts (under 200), meaning they started treatment late. Participants received either Biktarvy or a standard three-drug combination. The main goal was to see how many had undetectable virus levels at 12 weeks, with additional checks at 4, 24, and 48 weeks. The study also tracked changes in immune cell counts.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide)
What this could lead to
If successful, this could show that Biktarvy is a safe and effective option for people who start HIV treatment late, helping them achieve viral suppression and immune recovery.
What could go wrong
This is a completed Phase 4 trial with 202 participants, so results are already in. However, late presenters may have more advanced disease, and individual responses can vary. The study is open-label, which may introduce bias.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

202 people

The number who actually took part.

Started

Jul 2021

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV-1-infection

Contacts and locations

Locations

  • China Liaoning Dalian Public Health Clinical Center

    Dalian, Liaoning, China

  • Lanzhou Feike Hospital

    Lanzhou, Guansu, China

  • The Guangxi Zhuang Autonomous Region Longtan Hospital

    Liuzhou, Guangxi, 545005, China

  • The Second Hospital of Nanjing

    Najing, Jiangsu, 210003, China

  • Tianjin Second People's Hospital

    Tianjin, 300192, China

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