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HIV/AIDSPhase 3LAPTOPNCT03696160

The Late Presenter Treatment Optimisation Study

A Phase 3 study testing Biktarvy and Symtuza in people with HIV/AIDS, run by NEAT ID Foundation at 53 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The main purpose of this study is to compare two different types of HIV treatments, in terms of effectiveness and improvement of side effects, for patients who are diagnosed with a more advanced HIV infection. Patients with advanced HIV infections are otherwise known as 'late presenters'. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV/AIDS
What is being tested?
Biktarvy and Symtuza
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
447 participants
Where
53 sitesin 7 countries
Study dates
5 Mar 2019to 17 Jun 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The ability to understand and sign a written informed consent form (ICF) and must be willing to comply with all study requirements.
  • Male or non-pregnant, non-lactating females†.
  • Age ≥ 18 years.
  • Have documented, untreated HIV-1 infection with either:
  • AIDS with any CD4 cell count (AIDS-defining conditions are listed within Appendix 3).
  • Or
Show all 23Show fewer
  • Severe bacterial infection (BI)‡ and must have a CD4 cell count < 200/μl within 28 days prior to study entry§.
  • Or
  • 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
  • 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.
  • Have an entry HIV viral load > 1000 copies/mL
  • Have the ability to take oral medications.
  • 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

Who cannot join

  • Any therapeutic ARV which commenced less than 2 weeks prior to screening and which was taken for more than 48 hours
  • Systemic cancer chemotherapy within 30 days prior to study entry, or current treatment for cancer (with the exception of Kaposi's sarcoma) or lymphoma.
  • 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).
  • Known resistance to the components of study medications (see section 6.1.3 for more details).
  • 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.
  • Current drug or alcohol use that, in the opinion of the Investigator, would cause interference with the study.
Show all 12Show fewer
  • 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).
  • History or presence of allergy to the study drugs or their components, or drugs of their class.
  • Using any concomitant therapy disallowed as per the product labelling for the study drugs.
  • Any investigational drug within 30 days prior to the study drug administration.
  • Patients with severe (Child Pugh class C) hepatic impairment.
  • Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study.

Trial locations and contacts

53 sites in 7 countries.

53 sites in 7 countries

United Kingdom15 sites

  • Royal Bournemouth Hospital

    Bournemouth

  • Southmead Hospital

    Bristol

  • Leeds Teaching Hospital

    Leeds

  • Barts Health

    London

  • Chelsea and Westminister

    London

  • Guy's Hospital

    London

  • Homerton University Hospital

    London

  • Imperial College Healthcare Trust

    London

  • Kings College London

    London

  • Mortimer Market Centre

    London

  • Royal Free Hospital

    London

  • St George's Hospital

    London

  • University Hospital Lewisham

    London

  • North Manchester General Hospital

    Manchester

  • Sheffield Teaching Hospital

    Sheffield

Other trials in United Kingdom

Spain13 sites

  • Hospital General Universatario Alicante

    Alicante

  • Hospital Bellvitge

    Barcelona

  • Hospital Clinic (Helios Building)

    Barcelona

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

  • Hospital del Mar

    Barcelona

  • Hospital Trias i Pujol

    Barcelona

  • Hospital Universitari Vall d'Herbon

    Barcelona

  • Hospital General Universitatrio de Elche

    Elche

  • Hospital 12 Octubre

    Madrid

  • Hospital de la Princesa

    Madrid

  • Hospital Ramon y Cajal

    Madrid

  • Hospital Universitatrio La Paz

    Madrid

  • Hospital Virgen de la Victoria

    Málaga

Other trials in Spain

France8 sites

  • Hopital Europeen Marseille

    Marseille

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

    Melun

  • Hôpital Gui de Chauliac

    Montpellier

  • CHU de Nantes

    Nantes

  • Hopital Lariboisiere

    Paris

  • Hopital Saint-Louis

    Paris

  • Hôpital Saint Antoine

    Paris

  • Pitié-Salpêtrière Hospital

    Paris

Other trials in France

Germany7 sites

  • Medizinische Klinik und Poliklinik Universitätsklinikum Bonn

    Bonn

  • University Hospital Koln

    Cologne

  • Goethe University Hospital Frankfurt

    Frankfurt

  • University Hospital Geissen

    Geißen

  • ICH Study Center Gmbh & Co. KG

    Hamburg

  • Medizinische Hochschule Hannover

    Hanover

  • University Hospital Klinikum rechts der Isar der TUM

    Munich

Other trials in Germany

Italy5 sites

  • Luigi Sacco Hospital

    Milan

  • Ospedale San Raffaele

    Milan

  • ASST Santi Paolo

    Milan

  • Clinica of Infectious Diseases

    Modena

  • INMI Lazzaro Spallanzani, Rome

    Rome

Other trials in Italy

Belgium3 sites

  • Institute of Tropical Medicine

    Antwerp

  • CHU Saint-Pierre

    Brussels

  • University Hospital Ghent

    Ghent

Other trials in Belgium

Ireland2 sites

  • Mater Misericordiae University Hospital

    Dublin

  • St Vincent's University Hospital

    Dublin

Other trials in Ireland

About this study

Official title: An Open-Label, Multi-Centre, Randomised Study to Investigate Integrase Inhibitor Versus Boosted Protease Inhibitor Antiretroviral Therapy for Patients With Advanced HIV Disease

The main purpose of this study is to compare two different types of HIV treatments, in terms of effectiveness and improvement of side effects, for patients who are diagnosed with a more advanced HIV infection. Patients with advanced HIV infections are otherwise known as 'late presenters'.

There are many effective treatments for HIV available; however, for late presenting patients the investigators do not know which type of treatment performs best. This is the first large study to compare treatments for patients in this situation, and the investigators hope that the results of this study will help doctors decide which treatments to use in the future.

Read more

The two different types of treatment the investigators are comparing both contain a mixture of drugs that work together to combat HIV:

The Boosted Protease Inhibitor combination (PI) which is a combination tablet containing: darunavir, cobicistat, emtricitabine and tenofovir alafenamide. It was approved for use in Europe under the brand name Symtuza®.

The Integrase Inhibitor combination (INI). Which is a combination tablet containing: bictegravir, emtricitabine and tenofovir alafenamide. This is a a newer combination which was approved for use in Europe in June 2018 under the brand name of Biktarvy®.

The main difference between the two treatments is how each one fights a HIV infection. They both stop a part of the virus from working (i.e. inhibit it), to prevent it from making copies of itself. The PI treatment contains drugs to stop the protease part of the virus, whereas the INI treatment contains drugs to stop the integrase part.

In recent studies, it appears that treatments containing integrase inhibitors may be better for late presenting patients. They have been shown to quickly bring down the amount of virus in the body, and the side effects may be more acceptable to late presenters.

To compare the two treatments, half of the participants on this study will be given the PI treatment, and the other half will be given the INI treatment.

Read the detailed description

The effectiveness of HIV antiretroviral therapy (ART) has consistently improved over the years. This is largely due to newer drugs having improved antiviral effectiveness and more tolerable side effect profiles; resulting in better viral suppression and improved treatment adherence. On the other hand, most recent clinical trials look at the effectiveness of ART in patients with less advanced disease. These patients usually suffer from less related diseases, drug-drug interactions, and other risks for treatment failure. Outside of these trials, the number of patients who present to clinic with a more developed advanced HIV infection, known as 'late presenters', remains high across Europe. Trials for these patients have tended to focus on the time of starting treatment and the management of infections.

Much less is known about which ART treatments perform best for these late presenting patients; particularly in terms of virus suppression, immune system recovery, side effects and improvement of AIDs related diseases. No specific drug combinations have been compared in appropriate clinical trials before, and the international guidelines for first line treatment judge all therapies as equal standard of care for these patients.

The investigators anticipate that Integrase inhibitor containing regimes may be better suited to patients with advanced disease, due to their beneficial side-effect profile and ability to rapidly decrease viral load levels. Therefore the investigators are conducting this clinical trial to compare an integrase inhibitor regime, against a protease inhibitor regime in patients with advanced HIV infection. The aim of the study is to demonstrate the non-inferiority of Biktarvy® against Symtuza®.

Patients will be recruited from sites across Europe, and randomized onto either arm of the study. After randomisation onto either treatment regime, patients will attend approximately 9 follow-up visits over the course of a year. During these visits, patients will be asked to complete two questionnaires, to assess their quality of life and HIV symptoms. They will also be asked to provide a number of blood samples. These samples are to ensure that the patient is not resistant to the study drug and that their disease is not worsening. Samples to test for study drug resistance will be shipped to a laboratory for analysis in the even that the patient experiences virological failure.

Biktarvy® will be supplied from Gilead and Symtuza® will be provided by Janssen Pharmaceuticals.

Conditions
HIV/AIDS
Being tested
Biktarvy, Symtuza
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BiktarvyDrug

    Integrase inhibitor used to treat HIV-1 infection

  • SymtuzaDrug

    Protease inhibitor used to treat HIV-1 infection

Study groups in NCT03696160
Study groupRoleWhat they receive
BiktarvyExperimentalBictegravir is an inhibitor of HIV-1 integrase that is being evaluated for the treatment of HIV-1 infection. Biktarvy® received marketing authorisation valid throughout the European Union (EU) in June 2018. Biktarvy is a combination of bictegravir, emtricitabine, and tenofovir (B/F/TAF). Method of administration: One combined B 50mg/F 200mg/TAF 25mg tablet taken orally once daily for up to 48 weeks without regard to food.
Receives: Drug: Biktarvy
SymtuzaExperimentalSymtuza® is a boosted PI indicated for the treatment of HIV-1 infection. Symtuza® received marketing authorisation valid throughout the EU in September 2017. Symtuza is a combination of darunavir, cobicistat, emtricitabine and tenofovir alafenamide (D/C/F/TAF) Method of administration: One combined D 800mg/C 150mg/F 200mg/TAF 10mg tablet taken orally once daily for up to 48 weeks with the addition of food.
Receives: Drug: Symtuza

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment Failure

    Composite outcome: treatment failure due to either virological or clinical reasons. Virological reasons can either be insufficient virological response or viral rebound. Clinical reasons can be death related to HIV/AIDS/opportunistic infection or severe bacterial infection, new or recurrent AIDS defining event, any serious non-AIDS defining event or clinically relevant adverse events of any grade or immune reconstitution inflammatory syndrome requiring treatment

    Measured: Earliest at 12 weeks, latest 48 weeks

Secondary outcomes (12)

  1. Proportion of Patients With HIV-RNA Viral Load <50 Copies/mL

    at week 24, 36, 48

    Measured: Week 24, 36 and 48

  2. Time to Reach CD4 (Cluster of Differentiation 4) Count >200/µL

    Measured: Through study completion, up to 48 weeks.

  3. Proportion of Patients With CD4 Cell Count <200 and < 350μL at Week 4, 8, 12, 24, 36, 48

    Measured: 4, 8, 12, 24, 36, 48 weeks

  4. CD4/CD8 (Cluster of Differentiation 8) Ratio

    CD4/CD8 ratio at week 4, 8, 12, 24, 36, 48

    Measured: Week 4, 8, 12, 24, 36, 48

  5. Incidence of Immune Reconstitution Inflammatory Syndrome

    Incidence of Immune Reconstitution Inflammatory Syndrome

    Measured: Week 48

  6. Number of Participants With Hospitalisation or Relapse of Specific Opportunistic or Bacterial Infection

    Start/Stop of hospitalization for any reason Start/Stop of opportunistic infections as listed within Appendix 3 (AIDS defining events according to https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5710a2.htm) Start/Stop of severe BI, which consists of any of bacterial pneumonia, invasive bacterial infection (IBI) or any bacterial infectious disorder with grade 3 severity or requiring unscheduled hospital admission. An IBI is defined as the isolation of a bacterial organism from a normally sterile body site, or for bacterial nucleic acid to be detected at a normally sterile body site. Sterile body sites include blood, cerebrospinal fluid, pleural fluid, pericardial fluid, peritoneal fluid, joint fluid, bone aspirate, or a deep tissue abscess.

    Measured: Week 48

  7. Number of Participants With Treatment-related Adverse Events as Assessed by Division of AIDS Adverse Event (AE) Grading Table Corrected Version 2.1-July 2017

    Measured: Week 48

  8. ART and OI/BI Treatment Changes and Dose Modifications Due to Toxicities and DDI With ART, and IRIS Through Week 48

    Antiretroviral therapy and opportunistic or bacterial infection treatment changes and dose modifications due to toxicities and drug-drug interaction with antiretroviral therapy, and Immune Reconstitution Inflammatory Syndrome

    Measured: Week 48

  9. Health Care Resource Use, Including Number of Participants With Critical Care and Emergency Room Visits

    Measured: Week 48

  10. QOL and Functional Status Outcomes, Including Overall Self-reported QOL and Functional Status Compared in the Two Groups at Week 48

    EQ-5D-3L (European Quality of life - 5 Dimensions - 3 Levels) and HIV Symptoms Index questionnaires will be completed by patients throughout the study to assess any change throughout their treatment

    Quality of life (EQ-5D-3L questionnaire) Scale is VAS Score which runs from 0 (worst health imaginable) to 100 (best health imaginable). We report the mean change from Baseline to W48.

    The HIV Symptom Index score is the sum of frequency ratings for the 20 selected symptoms; the score could range from 0 to 80 (80 being worst score). We report the mean change from Baseline to W48.

    Measured: Week 48

  11. Discontinuation or Modification of Study Medication Due to Insufficient Virological Response or Resistance Mutation Development

    Discontinuation or modification of the single tablet regimen due virological reasons defined as a) Insufficient virological response, either:

    1. HIV-1 RNA reduction < 1 log 10 copies/mL at week 12, or
    2. Viral load > 50 HIV-1 RNA copies/mL at week 48 b) Viral rebound, which is subsequently confirmed at the following scheduled or unscheduled visit, defined as either:
    3. Rebound of HIV-1 RNA to >200 copies/mL after having achieved HIV-1 RNA <50 copies/mL b. Rebound of HIV RNA by >1 log 10 copies/mL from nadir value, for patients whose viral load has never been suppressed below 50 copies/mL

    Measured: Week 48

  12. Duration of Hospitalisations

    Duration of hospitalization for any reason

    Measured: Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2018
  2. Study start5 Mar 2019
  3. Primary completion17 Jun 2024
  4. Study completion17 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
447 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03696160
Sponsor's protocol ID
NEAT44
Acronym
LAPTOP
Status last verified
Dec 2025
First submitted
24 Sep 2018
Last updated
17 Dec 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • DeJesus E, Rockstroh JK, Henry K, Molina JM, Gathe J, Ramanathan S, Wei X, Yale K, Szwarcberg J, White K, Cheng AK, Kearney BP; GS-236-0103 Study Team. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus co-formulated emtricitabine and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet. 2012 Jun 30;379(9835):2429-2438. doi: 10.1016/S0140-6736(12)60918-0.

    PubMed 22748590

  • Raffi F, Rachlis A, Stellbrink HJ, Hardy WD, Torti C, Orkin C, Bloch M, Podzamczer D, Pokrovsky V, Pulido F, Almond S, Margolis D, Brennan C, Min S; SPRING-2 Study Group. Once-daily dolutegravir versus raltegravir in antiretroviral-naive adults with HIV-1 infection: 48 week results from the randomised, double-blind, non-inferiority SPRING-2 study. Lancet. 2013 Mar 2;381(9868):735-43. doi: 10.1016/S0140-6736(12)61853-4. Epub 2013 Jan 8.

    PubMed 23306000

  • Walmsley SL, Antela A, Clumeck N, Duiculescu D, Eberhard A, Gutierrez F, Hocqueloux L, Maggiolo F, Sandkovsky U, Granier C, Pappa K, Wynne B, Min S, Nichols G; SINGLE Investigators. Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection. N Engl J Med. 2013 Nov 7;369(19):1807-18. doi: 10.1056/NEJMoa1215541.

    PubMed 24195548

  • Sax et al. Phase 3 Randomized, Controlled, Clinical Trial of Bictegravir Coformulated With FTC/TAF in a Fixed-Dose Combination vs Dolutegravir + FTC/TAF in Treatment-Naïve HIV-1-Positive Adults: Week 48 Results. 9th IAS Conference on HIV Science; Paris, France; July 23-26, 2017

  • Gallant et al. A phase 3 randomized controlled clinical trial of bictegravir in a fixed dose combination, B/F/TAF, vs ABC/DTG/3TC in treatment-naïve adults at week 48. 9th IAS Conference on HIV Science; Paris, France; July 23-26, 2017. MOAB0105LB

  • Camoni L, Raimondo M, Regine V, Salfa MC, Suligoi B; regional representatives of the HIV Surveillance System. Late presenters among persons with a new HIV diagnosis in Italy, 2010-2011. BMC Public Health. 2013 Mar 27;13:281. doi: 10.1186/1471-2458-13-281.

    PubMed 23537210

  • Montlahuc C, Guiguet M, Abgrall S, Daneluzzi V, de Salvador F, Launay O, Martinez V, Partisani M, Pradier C, Rouveix E, Valin N, Grabar S, Costagliola D; French Hospital Database ANRS CO4 cohort. Impact of late presentation on the risk of death among HIV-infected people in France (2003-2009). J Acquir Immune Defic Syndr. 2013 Oct 1;64(2):197-203. doi: 10.1097/QAI.0b013e31829cfbfa.

    PubMed 24047970

  • Antinori A, Coenen T, Costagiola D, Dedes N, Ellefson M, Gatell J, Girardi E, Johnson M, Kirk O, Lundgren J, Mocroft A, D'Arminio Monforte A, Phillips A, Raben D, Rockstroh JK, Sabin C, Sonnerborg A, De Wolf F; European Late Presenter Consensus Working Group. Late presentation of HIV infection: a consensus definition. HIV Med. 2011 Jan;12(1):61-4. doi: 10.1111/j.1468-1293.2010.00857.x.

    PubMed 20561080

  • Raffetti E, Postorino MC, Castelli F, Casari S, Castelnuovo F, Maggiolo F, Di Filippo E, D'Avino A, Gori A, Ladisa N, Di Pietro M, Sighinolfi L, Zacchi F, Torti C. The risk of late or advanced presentation of HIV infected patients is still high, associated factors evolve but impact on overall mortality is vanishing over calendar years: results from the Italian MASTER Cohort. BMC Public Health. 2016 Aug 25;16(1):878. doi: 10.1186/s12889-016-3477-z.

    PubMed 27557878

  • Sobrino-Vegas P, Rodriguez-Urrego J, Berenguer J, Caro-Murillo AM, Blanco JR, Viciana P, Moreno S, Bernardino I, del Amo J; CoRIS. Educational gradient in HIV diagnosis delay, mortality, antiretroviral treatment initiation and response in a country with universal health care. Antivir Ther. 2012;17(1):1-8. doi: 10.3851/IMP1939.

    PubMed 22267463

  • Late presenters working group in COHERE in EuroCoord; Mocroft A, Lundgren J, Antinori A, Monforte Ad, Brannstrom J, Bonnet F, Brockmeyer N, Casabona J, Castagna A, Costagliola D, De Wit S, Fatkenheuer G, Furrer H, Jadand C, Johnson A, Lazanas M, Leport C, Moreno S, Mussini C, Obel N, Post F, Reiss P, Sabin C, Skaletz-Rorowski A, Suarez-Loano I, Torti C, Warszawski J, Wittkop L, Zangerle R, Chene G, Raben D, Kirk O. Late presentation for HIV care across Europe: update from the Collaboration of Observational HIV Epidemiological Research Europe (COHERE) study, 2010 to 2013. Euro Surveill. 2015;20(47). doi: 10.2807/1560-7917.ES.2015.20.47.30070.

    PubMed 26624933

  • Abdool Karim SS, Naidoo K, Grobler A, Padayatchi N, Baxter C, Gray AL, Gengiah T, Gengiah S, Naidoo A, Jithoo N, Nair G, El-Sadr WM, Friedland G, Abdool Karim Q. Integration of antiretroviral therapy with tuberculosis treatment. N Engl J Med. 2011 Oct 20;365(16):1492-501. doi: 10.1056/NEJMoa1014181.

    PubMed 22010915

  • Blanc FX, Sok T, Laureillard D, Borand L, Rekacewicz C, Nerrienet E, Madec Y, Marcy O, Chan S, Prak N, Kim C, Lak KK, Hak C, Dim B, Sin CI, Sun S, Guillard B, Sar B, Vong S, Fernandez M, Fox L, Delfraissy JF, Goldfeld AE; CAMELIA (ANRS 1295-CIPRA KH001) Study Team. Earlier versus later start of antiretroviral therapy in HIV-infected adults with tuberculosis. N Engl J Med. 2011 Oct 20;365(16):1471-81. doi: 10.1056/NEJMoa1013911.

    PubMed 22010913

  • Zolopa A, Andersen J, Powderly W, Sanchez A, Sanne I, Suckow C, Hogg E, Komarow L. Early antiretroviral therapy reduces AIDS progression/death in individuals with acute opportunistic infections: a multicenter randomized strategy trial. PLoS One. 2009;4(5):e5575. doi: 10.1371/journal.pone.0005575. Epub 2009 May 18.

    PubMed 19440326

  • Mussini C, Manzardo C, Johnson M, Monforte Ad, Uberti-Foppa C, Antinori A, Gill MJ, Sighinolfi L, Borghi V, Lazzarin A, Miro JM, Sabin C; Late Presenter Investigators. Patients presenting with AIDS in the HAART era: a collaborative cohort analysis. AIDS. 2008 Nov 30;22(18):2461-9. doi: 10.1097/QAD.0b013e328314b5f1.

    PubMed 19005269

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Biktarvy and Symtuza in people with HIV/AIDS, run by NEAT ID Foundation at 53 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United Kingdom, Spain, France, Germany, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Failure (time frame: Earliest at 12 weeks, latest 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03696160, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.

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