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HIV treatment showdown: which combo works best for Late-Stage patients?

NCT ID NCT03696160

Disease control Sponsor: NEAT ID Foundation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compared two different HIV drug combinations in 447 people with advanced HIV (late presenters). One group received a protease inhibitor combo (Symtuza), the other an integrase inhibitor combo (Biktarvy). The goal was to see which works better and has fewer side effects. Results help doctors choose the best treatment for this group.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

447 people

The number who actually took part.

Started

Mar 2019

Finished

Jun 2024

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. The ability to understand and sign a written informed consent form (ICF) and must be willing to comply with all study requirements. 2. Male or non-pregnant, non-lactating females†. 3. Age ≥ 18 years. 4. Have documented, untreated HIV-1 infection with either: 1. AIDS with any CD4 cell count (AIDS-defining conditions are listed within Appendix 3). Or 2. Severe bacterial infection (BI)‡ and must have a CD4 cell count \< 200/μl within 28 days prior to study entry§. Or 3. Any symptoms or no symptoms and must have a CD4 cell count \< 100/μL within 28 days prior to study entry and must have an entry HIV viral load \> 1000 copies/mL. Or 4. Currently receiving treatment for OI\*\*. i. Subjects with other serious OIs, including other AIDS-defining and AIDS-related OIs for which appropriate therapy other than ART exists are eligible, but Investigator approval must be obtained. ii. Current OI treatment can have been discontinued prior to start of ART. 5. Have an entry HIV viral load \> 1000 copies/mL 6. Have the ability to take oral medications. 7. Females of childbearing potential and heterosexually active males must be willing to use a highly effective method of contraception and be willing to continue practising these birth control methods during the trial and for at least 30 days after the last dose of study medication. See Appendix 7 for further details. Such methods include: * True abstinence from penile-vaginal intercourse, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), and withdrawal are not acceptable methods of contraception). * Non-hormonal Intrauterine device or non-hormonal intrauterine system that meets the effectiveness criteria as stated in the product label. * Male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject. * Combined (oestrogen and progesterone containing) hormonal contraception associated with the inhibition of ovulation\*: * Oral * Intravaginal * Transdermal * Bilateral tubal occlusion Exclusion Criteria: 1. Any therapeutic ARV which commenced less than 2 weeks prior to screening and which was taken for more than 48 hours 2. Systemic cancer chemotherapy within 30 days prior to study entry, or current treatment for cancer (with the exception of Kaposi's sarcoma) or lymphoma. 3. Current or anticipated use of contraindicated medications (see Summary of Product Characteristics (SmPC) for Symtuza® and Biktarvy®) or anticipated systemic chemotherapy during study enrolment (administration of any contraindicated medication must be discontinued at least 30 days prior to the baseline visit and for the duration of the study). 4. Known resistance to the components of study medications (see section 6.1.3 for more details). 5. History or symptoms of advanced renal and/or hepatic impairment. Such as, kidney failure requiring dialysis; eGFR \<30 mL/min; hepatic transaminases (AST and ALT) \> 5 x upper limit of normal (ULN); or, platelet count \<50,000. 6. Current drug or alcohol use that, in the opinion of the Investigator, would cause interference with the study. 7. Cryptococcal meningitis or active TB, or current or expected treatment requiring Rifampicin or Rifabutin (patients with expected latent TB will have a TB test (IGRAs e.g. ELISPOT, QuantiFERON etc.) at their screening visit). 8. History or presence of allergy to the study drugs or their components, or drugs of their class. 9. Using any concomitant therapy disallowed as per the product labelling for the study drugs. 10. Any investigational drug within 30 days prior to the study drug administration. 11. Patients with severe (Child Pugh class C) hepatic impairment. 12. Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study.

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease

As listed by the trial registrant

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

HIV/AIDS

Contacts and locations

Locations

  • ASST Santi Paolo

    Milan, Italy

  • Barts Health

    London, United Kingdom

  • CHU Saint-Pierre

    Brussels, Belgium

  • CHU de Nantes

    Nantes, France

  • Chelsea and Westminister

    London, United Kingdom

  • Clinica of Infectious Diseases

    Modena, Italy

  • Goethe University Hospital Frankfurt

    Frankfurt, Germany

  • Groupe Hospitalier Sud Ile-de-France (Melun)

    Melun, France

  • Guy's Hospital

    London, United Kingdom

  • Homerton University Hospital

    London, United Kingdom

  • Hopital Europeen Marseille

    Marseille, France

  • Hopital Lariboisiere

    Paris, France

  • Hopital Saint-Louis

    Paris, France

  • Hospital 12 Octubre

    Madrid, Spain

  • Hospital Bellvitge

    Barcelona, Spain

  • Hospital Clinic (Helios Building)

    Barcelona, Spain

  • Hospital General Universatario Alicante

    Alicante, Spain

  • Hospital General Universitatrio de Elche

    Elche, Spain

  • Hospital Ramon y Cajal

    Madrid, Spain

  • Hospital Trias i Pujol

    Barcelona, Spain

  • Hospital Universitari Vall d'Herbon

    Barcelona, Spain

  • Hospital Universitatrio La Paz

    Madrid, Spain

  • Hospital Virgen de la Victoria

    Málaga, Spain

  • Hospital de la Princesa

    Madrid, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Spain

  • Hospital del Mar

    Barcelona, Spain

  • Hôpital Gui de Chauliac

    Montpellier, France

  • Hôpital Saint Antoine

    Paris, France

  • ICH Study Center Gmbh & Co. KG

    Hamburg, Germany

  • INMI Lazzaro Spallanzani, Rome

    Rome, Italy

  • Imperial College Healthcare Trust

    London, United Kingdom

  • Institute of Tropical Medicine

    Antwerp, Belgium

  • Kings College London

    London, United Kingdom

  • Leeds Teaching Hospital

    Leeds, United Kingdom

  • Luigi Sacco Hospital

    Milan, Italy

  • Mater Misericordiae University Hospital

    Dublin, Ireland

  • Medizinische Hochschule Hannover

    Hanover, Germany

  • Medizinische Klinik und Poliklinik Universitätsklinikum Bonn

    Bonn, Germany

  • Mortimer Market Centre

    London, United Kingdom

  • North Manchester General Hospital

    Manchester, United Kingdom

  • Ospedale San Raffaele

    Milan, Italy

  • Pitié-Salpêtrière Hospital

    Paris, France

  • Royal Bournemouth Hospital

    Bournemouth, United Kingdom

  • Royal Free Hospital

    London, United Kingdom

  • Sheffield Teaching Hospital

    Sheffield, United Kingdom

  • Southmead Hospital

    Bristol, United Kingdom

  • St George's Hospital

    London, United Kingdom

  • St Vincent's University Hospital

    Dublin, Ireland

  • University Hospital Geissen

    Geißen, Germany

  • University Hospital Ghent

    Ghent, Belgium

  • University Hospital Klinikum rechts der Isar der TUM

    Munich, Germany

  • University Hospital Koln

    Cologne, Germany

  • University Hospital Lewisham

    London, United Kingdom

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