AzTrials
AzTrials

HIV-1-infectionPhase 3WISARDNCT05349838

Open-Label Multi-Centre Randomised Switch Study to Evaluate Virological Efficacy Over 96Weeks Of 2-Drug Therapy With Dolutegravir(DTG)/Rilpivirine(RPV) Fixed Dose Combination(FDC) in Antiretroviral Treatment-Experienced HIV-1 Infected Subjects Virologically Suppressed With NNRTI Mutation K103N

A Phase 3 study testing Dolutegravir & Rilpivirine 2 drug fixed dose combined therapy in people with HIV-1-infection, run by NEAT ID Foundation at 29 sites in 6 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

HIV-1 infected subjects that experience virological failure while on non nucleoside reverse-transcriptase inhibitors (NNRTIs), including those with the K103N mutation, are usually switched to a boosted Protease Inhibitor (PI)-based regimen or other antiretroviral (ARV) combinations. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV-1-infection
What is being tested?
Dolutegravir & Rilpivirine 2 drug fixed dose combined therapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
29 sitesin 6 countries
Study dates
5 Nov 2018to 9 Nov 2022
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

  • Patient volunteers who meet all of the following criteria are eligible for this trial:
  • Is male or female aged 18 years or over.
  • Has documented HIV-1 infection
  • Is capable of giving informed consent
  • Is willing to comply with the protocol requirements
  • Virologically suppressed (plasma HIV-RNA <50 copies/mL for >24 weeks) and on a stable regimen.
Show all 20Show fewer
  • Subjects are required to have a history of the K103N mutation (acquired or selected). Subjects who at any time have had the mutations 100I, 101E/P, 106A/M, 138K/G/Q, 181C/I/V, 188L, 190A/S/E/Q, 230L mutations are to be excluded. Other NNRTI region variants can be included. All PI and NRTI mutations are acceptable. Study sites may ask the coordinating centre for advice as required.
  • Subjects must have never failed INSTI (2 x VL >200 >2 weeks apart) but current regimen can include Integrase Strand Transfer Inhibitor(INSTI).
  • A female, may be eligible to enter and participate in the study if she:
  • is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea without an alternative medical cause and ≥ 45 years of age) A high follicle stimulating hormone (FSH) level consistent with postmenopausal status may be used to confirm a post- menopausal state in women who are not using hormonal contraception) or hormonal replacement therapy at the discretion of the Principal Investigator. However, in the absence of 12 months of amenorrhea, a single FSH measurement alone is insufficient.
  • OR physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or,
  • OR is of child-bearing potential with a negative pregnancy test at Screening (\& baseline visit) and agrees to use one of the following methods of contraception to avoid pregnancy:
  • True abstinence from penile-vaginal intercourse from 2 weeks prior to administration of IP, throughout the study, and for at least 2 weeks after discontinuation of all study medications (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.
  • Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year (not all IUDs meet this criterion, see Appendix 3 for an example listing of approved IUDs).
  • Male partner sterilization confirmed prior to the female subject's entry into the study, and this male is the sole partner for that subject;
  • Approved hormonal contraception (see appendix 4 for a listing of examples of approved hormonal contraception);
  • Any other method with published data showing that the expected failure rate is <1% per year.
  • Any contraceptive method must be used consistently and for at least 2 weeks after discontinuation of Investigational Product (IP)
  • If a heterosexually active male, he is using effective birth control methods and is willing to continue practising these birth control methods during the trial and until follow-up visit
  • Subjects currently receiving DTG or RPV, but not both, can be included.

Who cannot join

  • Patients meeting 1 or more of the following criteria cannot be selected:
  • Infected with HIV-2
  • Detectable HIV-1 RNA at screening (HIV-1 RNA measurement >=50 c/mL).
  • Subjects requiring regular dosing doing with H2 or PPI antacid medications or a history of achlorhidria or drug known to interact with RPV or DTG.
  • Use of medications which are associated with Torsades de Pointes
  • Corrected QT interval (QTc [Bazett]) >450 milliseconds or QTc (Bazett) >480 milliseconds for participants with bundle branch block. The QTc is the QT interval corrected for heart rate according to Bazett's formula (QTcB).
Show all 44Show fewer
  • Unstable health conditions (i.e. opportunistic infections, cancers, unstable liver disease etc).
  • Any evidence of an active Centers for Disease Control and Prevention Category C disease. Exceptions include cutaneous Kaposi's sarcoma not requiring systemic therapy and historic CD4+ lymphocyte counts of <200 cells/millimeter3.
  • History or presence of allergy to the study drugs or their components or drugs of their class;
  • Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the subject prior to randomization;
  • Any pre-existing physical or mental condition which, in the opinion of the Investigator, may interfere with the subject's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participants. Subjects considered to pose a significant risk of suicide should be excluded.
  • Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the subject unable to take oral medication;
  • Using any concomitant therapy disallowed as per the reference safety information and product labelling for the study drugs. Specifically, co-administration with the following medicinal products is not allowed:
  • dofetilide or pilsicainide;
  • fampridine (also known as dalfampridine);
  • carbamazepine, oxcarbazepine, phenobarbital, phenytoin;
  • rifampicin, rifapentine;
  • proton pump inhibitors, such as omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole; - systemic dexamethasone, except as a single dose treatment;
  • St John's wort (Hypericum perforatum).
  • Has acute viral hepatitis including, but not limited to, A, B, or C
  • Active hepatitis B/ Hep B non-immune subjects who have failed vaccination (antibody concentration < 10 international units). (If local practice does not include vaccination of low risk patients, then the patients without HBsAb are not excluded - this must be clearly documented in the medical records and eCRF). (Note: subjects can be re screened if they receive vaccination and subsequently meet eligibility criteria)
  • Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), and Hepatitis B surface antibody (HBsAb) as follows: Participants positive for HBsAg are excluded; Participants positive for anti-HBc (negative HBsAg status) and negative for HBsAb are excluded. (if local practice does not include vaccination of low risk patients, then the patients without HBsAb are not excluded - this must be clearly documented in the medical records and eCRF. Note: Subject positive for anti-HBc (negative HBsAg status) and positive for HBsAb are immune to HBV and are not excluded.
  • Participants with an anticipated need for any Hepatitis C virus (HCV) therapy during the Early Switch Phase and for interferon-based therapy for HCV throughout the entire study period.
  • Any investigational drug within 30 days prior to the trial drug administration
  • Any evidence of viral resistance different to the one described in the inclusion criteria i.e. not meeting inclusion criteria or having different mutation at K103.
  • Dialysis or renal insufficiency (creatinine clearance < 50ml/min)
  • History of decompensated liver disease (Alanine aminotransferase (ALT) ≥ 5 times the upper limit of normal (ULN), OR ALT ≥3xULN and bilirubin ≥1.5xULN (with >35% direct bilirubin)
  • Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
  • Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification (see appendix 4)
  • Opportunistic infection within 4 weeks prior to first dose of DTG plus RPV.
  • Clinical decision that a switch of antiretroviral therapy should be immediate
  • Screening blood result with any grade 3/4 toxicity according to Division of AIDS (DAIDS) grading scale, except: asymptomatic grade 3 glucose, amylase or lipid elevation or asymptomatic grade 4 triglyceride elevation (re-test allowed). or unconjugated hyperbilirubinaemia due to atanazavir exposure.
  • Any condition (including illicit drug use or alcohol abuse) or laboratory results which, in the investigator's opinion, interfere with assessments or completion of the trial.
  • Women planning pregnancy or who are pregnant or breast feeding. (NB: See section 6.12 Withdrawal Criteria for guidance if pregnancy does occur).
  • Females of childbearing potential and males must be willing to use a highly effective (acceptable effective contraceptive measures are only acceptable for IMP's with unlikely human teratogenicity / fetotoxicity in early pregnancy) method of contraception (hormonal method of birth control; true abstinence). Contraceptive methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods (see Appendix 4). Such methods include:
  • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral intravaginal transdermal
  • progesteron-only hormonal contraception associated with inhibition of ovulation oral injectable implantable
  • Intrauterine device (IUD)
  • Intrauterine hormone-releasing system ( IUS)
  • bilateral tubal occlusion
  • vasectomized partner
  • true sexual abstinence
  • (NB: See section 6.12 Withdrawal Criteria for guidance if pregnancy does occur).
  • Hypersensitivity to the active substances or to any of the excipients listed below: List of excipients Tablet core • Mannitol (E421) • Magnesium stearate • Microcrystalline cellulose • Povidone (K29/32) • Sodium starch glycolate • Sodium stearyl fumarate • Lactose monohydrate • Croscarmellose sodium • Povidone (K30) • Polysorbate 20 • Silicified microcrystalline cellulose Tablet coating • Polyvinyl alcohol- part hydrolysed • Titanium dioxide (E171) • Macrogol • Talc • Iron oxide yellow (E172) Iron oxide red (E172)

Trial locations and contacts

29 sites in 6 countries.

29 sites in 6 countries

United Kingdom9 sites

  • Brighton & Sussex University NHS Trust

    Brighton

  • North Bristol NHS Trust, Southmead Hospital

    Bristol

  • Chelsea & Westminster Hospital

    London

  • Kings College Hospital London

    London

  • Mortimer Market Centre

    London

  • Queen Elizabeth Hospital

    London

  • Royal Free London NHS Foundation Trust

    London

  • St Marys Hospital

    London

  • The Royal London Hospital

    London

Other trials in United Kingdom

Spain6 sites

  • Hospital General Universitario de Alicante

    Alicante

  • Hospital Clínic de Barcelona

    Barcelona

  • Hospital Universitari Vall d'Herbo

    Barcelona

  • Infectious Diseases Unit Hospital de la Santa Creu i Sant Pau

    Barcelona

  • Hospital General Universitario de Elche

    Elche

  • Hospital Universitario La Paz, Madrid

    Madrid

Other trials in Spain

Italy5 sites

  • AAST delgi spedali civili di Brescia

    Brescia

  • ASST FBF SACCO- I Division of Infectious Diseases 1

    Milan

  • ASST FBF SACCO- I Division of Infectious Diseases 3

    Milan

  • I.R.C.C.S San Raffaele Hospital

    Milan

  • ASST GOM Niguarda Milano, Dep. Infectious Disease

    Milan

Other trials in Italy

Germany4 sites

  • University Bonn

    Bonn

  • University Essen

    Essen

  • Frankfurt University Hospital

    Frankfurt

  • ICH Study Center, Hamburg

    Hamburg

Other trials in Germany

France3 sites

  • CHU Hotel Dieu

    Nantes

  • Hospital Saint Louis

    Paris

  • Pitié-salpêtrière Hospital

    Paris

Other trials in France

Belgium2 sites

  • Institute of Tropical Medecine

    Antwerp

  • St Pierre University Hospital

    Brussels

Other trials in Belgium

About this study

Official title: An Open-Label, Multi-Centre, Randomised, Switch Study to Evaluate the Virological Efficacy Over 96 Weeks Of 2-Drug Therapy With DTG/RPV FDC in Antiretroviral Treatment-Experienced HIV-1 Infected Subjects Virologically Suppressed With Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) Resistance Mutation K103N

HIV-1 infected subjects that experience virological failure while on non nucleoside reverse-transcriptase inhibitors (NNRTIs), including those with the K103N mutation, are usually switched to a boosted Protease Inhibitor (PI)-based regimen or other antiretroviral (ARV) combinations. The same is true for subjects who need to start antiretroviral therapy and have acquired virus that is already resistant to antiretrovirals. These "second line" combinations are often associated with numerous issues that can have a potential impact on the quality of life (QoL) of these patients. Therefore a simpler and better tolerated alternative second line treatment option would be a useful tool for the clinical management of these patients.

The aim of this study is to assess the efficacy and tolerability of a dual combined therapy of Dolutegravir (DTG) 50 mg Once Daily (OD) + Rilpivirine (RPV) 25 mg OD in virologically suppressed participants with previous virological failure with NNRTIs and having the clinically significant mutation K103N. The secondary objective of the study is to assess whether a simplification of the treatment in terms of pill burden, long term metabolic toxicity and potential for drug interactions improves the QOL of the participants. The study will also evaluate DTG \& RPV concentrations in the blood plus changes in cell associated virus.

In order to compare the first line treatment (boosted PI and/or other antiretroviral combinations) and the DTG+RPV combination, two thirds of study participants will be switched to DTG+RPV immediately and receive DTG+RPV for 96 weeks. The other third will be switched after 48 weeks of continuing on their first line treatment and receive DTG+RPV for 48 weeks. All participants will then be followed up for a further 30 days. Participants will be recruited from sites across Europe, and randomised onto either arm of the study. After randomisation, participants will attend approximately 10 visits over the course of two years.

Conditions
HIV-1-infection
Being tested
Dolutegravir & Rilpivirine 2 drug fixed dose combined therapy

What participants receive

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

  • Dolutegravir & Rilpivirine 2 drug fixed dose combined therapyDrug

    Also called Boosted protease inhibitors or other ARV regimen

    Daily oral tablet

Study groups in NCT05349838
Study groupRoleWhat they receive
DTG/RPV FDC RegimenExperimentalOne combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily
Receives: Drug: Dolutegravir & Rilpivirine 2 drug fixed dose combined therapy
Continued ART RegimenActive comparatorPatients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks.
Receives: Drug: Dolutegravir & Rilpivirine 2 drug fixed dose combined therapy

What is being measured

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

  1. Number of Participants With and Without Virological Suppression

    Virological Suppression is defined as <50 copies/ml HIV RNA

    Measured: 48 weeks

Secondary outcomes (29)

  1. Number of Participants With and Without Virological Suppression

    Virological Suppression is defined as <50 copies/ml HIV RNA

    Measured: week 96

  2. Changes in Blood Cell Counts - Red Blood Cells

    red blood cell count evaluation

    Measured: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

  3. Changes in Blood Cell Counts - White Blood Cells

    white blood cell count evaluation

    Measured: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

  4. Changes in Blood Cell Counts - Platelets

    platelet count evaluation

    Measured: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

  5. Changes in Blood Cell Counts - Haemoglobin

    Haemoglobin count evaluation

    Measured: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

  6. Change From Baseline in Sodium

    Change from baseline in Sodium

    Measured: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

  7. Changes in Liver Levels - Bilirubin

    Liver level evaluation - bilirubin

    Measured: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

  8. Changes in Liver Levels - Alanine Aminotransferase (ALT)

    Liver level evaluation - ALT

    Measured: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

  9. Changes in Renal Markers - Creatinine Clearance (Estimated Glomerular Filtration Rate(eGFR))

    Renal markers evaluation- creatinine clearance (eGFR)

    Measured: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

  10. Change From Baseline in Glucose

    Change from baseline in Glucose

    Measured: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

  11. Changes in Renal Markers - Creatinine

    Renal markers evaluation - creatinine

    Measured: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

  12. Changes in Bone Markers - Alkaline Phosphatase

    Bone markers evaluation - Alkaline phosphatase

    Measured: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

  13. Changes in Fasting Lipids From Baseline - Total Cholesterol

    Fasting lipids level evaluation - total cholesterol

    Measured: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

  14. Changes in Fasting Lipids From Baseline - High Density Lipoprotein (HDL)

    Fasting lipids level evaluation - HDL

    Measured: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

  15. Changes in Quality of Life Health Status Score

    Questionnaire (EQ-5D-3L) Mobility, Self-care, Usual activities, Pain/Discomfort and Anxiety/Depression are recorded on 3 point scale (tick boxes), which indicates the severity of problems the participant has with each of these activities. Patients will select No problems, Some problems or Extreme problems/Unable to perform. Patients also report their current Health State on a Scale from 1 to 100 on which the best state you can imagine is marked 100 and the worst state you can imagine is marked 0.

    Measured: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

  16. Changes in Patient Satisfaction - HIV Treatment Satisfaction Questionnaire (HIVTSQs)

    HIV Treatment Satisfaction Questionnaire (HIVTSQs) Answers are recorded on a scale from 0 to 6, with 0 being least satisfied and 6 being most satisfied.

    Measured: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

  17. Number of Participants With Adverse Events - Baseline to Week 48

    Adverse Events reports (AEs, SAEs and treatment discontinuation)

    Measured: Baseline to week 48

  18. Number of Drug Drug Interactions

    Comparing the drug interaction outcomes between antiretroviral therapy and co-medications before and after the switch by using the www.hiv-druginteractions.org/ website (within the same study arm)

    Measured: Baseline, week 24, week 48, week 96

  19. Changes in Fasting Lipids From Baseline - Triglycerides

    Fasting lipids level evaluation - triglycerides

    Measured: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

  20. Changes in Fasting Lipids From Baseline - Low Density Lipoprotein (LDL)

    Fasting lipids level evaluation - LDL

    Measured: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

  21. Changes in Vital Signs From Baseline - Systolic Blood Pressure

    Changes in Vital Signs from baseline - Systolic Blood Pressure

    Measured: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

  22. Changes in Vital Signs From Baseline - Diastolic Blood Pressure

    Changes in Vital Signs from baseline - Diastolic Blood Pressure

    Measured: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

  23. Changes in Vital Signs From Baseline - Pulse Rate

    Changes in Vital Signs from baseline - Pulse rate

    Measured: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

  24. Changes in Pittsburgh Sleep Quality Index (PSQI)

    The PSQI measures several different aspects of sleep, with seven component scores and one composite score. The component scores include questions on subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.

    Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance to sleep. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties

    Measured: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

  25. Number of Participants With Adverse Events - Week 48 to Week 96

    Adverse Events reports (AEs, SAEs and treatment discontinuation)

    Measured: From Week 48 to week 96

  26. Change From Baseline in CD4

    Measured: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

  27. Change From Baseline in CD8 Cell Count

    Change from baseline to week 48, Change from week 48 to week 96; Change from baseline to week 96 in participants in the DTG/RPV FDC Regimen and Continued ART Regimen arms

    Measured: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

  28. Change From Baseline in Body Weight

    Measured: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

  29. Change From Baseline in BMI

    Measured: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Timeline

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

  1. First posted27 Apr 2022
  2. Study start5 Nov 2018
  3. Primary completion15 Nov 2021
  4. Study completion9 Nov 2022

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
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05349838
Sponsor's protocol ID
NEAT 33
Other IDs
2017-004040-38, 2017
Acronym
WISARD
Status last verified
Nov 2024
First submitted
2 May 2019
Last updated
24 Dec 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Moyle G, Assoumou L, De Castro N, Post FA, Curran A, Rusconi S, De Wit S, Stephan C, Raffi F, Johnson M, Masia M, Vera J, Jones B, Fletcher C, Morris K, Pozniak A; for NEAT Foundation, WISARD study group. Durable efficacy of dolutegravir/rilpivirine switch in subjects with HIV RNA <50 copies/ml and history of K103N mutation. AIDS. 2026 Jul 1;40(7):885-893. doi: 10.1097/QAD.0000000000004451. Epub 2026 Jan 22.

    PubMed 41587441

  • Moyle G, Assoumou L, de Castro N, Post FA, Curran A, Rusconi S, De Wit S, Stephan C, Raffi F, Johnson M, Masia M, Vera J, Jones B, Grove R, Fletcher C, Duffy A, Morris K, Pozniak A; NEAT ID Foundation and the WISARD study group. Switching to dolutegravir plus rilpivirine versus maintaining current antiretroviral therapy regimen in virologically suppressed people with HIV-1 and the Lys103Asn (K103N) mutation: 48-week results from a randomised, open-label pilot clinical trial. Lancet HIV. 2024 Mar;11(3):e156-e166. doi: 10.1016/S2352-3018(23)00292-8.

    PubMed 38417976

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dolutegravir & Rilpivirine 2 drug fixed dose combined therapy in people with HIV-1-infection, run by NEAT ID Foundation at 29 sites in 6 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 20 inclusion and 44 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 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United Kingdom, Spain, Italy, Germany, France and 1 more country. 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 24 Dec 2024). 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?

Number of Participants With and Without Virological Suppression (time frame: 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 NCT05349838, which also lists 2 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 24 Dec 2024.

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