A Dose-Range Finding Clinical Trial Study in Human Immunodeficiency Virus (HIV-1) Infected Treatment-Naive Adults

  • End date
    Aug 8, 2028
  • participants needed
  • sponsor
    ViiV Healthcare
Updated on 14 July 2021
body mass index
pre-exposure prophylaxis (prep)
HIV Vaccine
antiviral drugs
hiv-1 rna measurement


This is a phase 2b, randomized, multicenter, parallel group, partially blind (to GSK3640254 doses [100, 150 and 200 milligrams {mg}]), active controlled clinical trial. It will aim to investigate the safety, efficacy and dose-response of GSK3640254 compared to dolutegravir (DTG), each given in combination with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) (abacavir/lamivudine [ABC/3TC] or emtricitabine/tenofovir alafenamide [FTC/TAF])

Condition HIV infection, Immunodeficiency, Primary Immunodeficiency Disorders, HIV Infections, human immunodeficiency virus, hiv disease
Treatment dolutegravir, Placebo, FTC/TAF, GSK3640254, ABC/3TC
Clinical Study IdentifierNCT04493216
SponsorViiV Healthcare
Last Modified on14 July 2021


Yes No Not Sure

Inclusion Criteria

Participants must be 18 years of age inclusive, at the time of signing the informed consent
Treatment-naive, defined as no anti-retrovirals (ARVs) (in combination or monotherapy) received after the diagnosis of HIV-1 infection (for example [e.g.], use of Pre-exposure prophylaxis [PreP] meets inclusion
Documented HIV infection and Screening plasma HIV-1 RNA greater than or equal to (>=)1000 c/mL
Screening CD4+ T-cell count >=300 cells/mm^3
Antiviral susceptibility to the NRTI backbone selected should be demonstrated
Body weight >=50.0 kilograms (kg) (110 pounds [lbs]) for men and >=45.0 kg (99 lbs) for women and body mass index (BMI) greater than (>)18.5 kg/meter square (m^2).Calculations will utilize sex assigned at birth
Participants who are male at birth and participants who are female at birth
Participants who are female at birth: Contraceptive use by participant who are female at birth should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
A participant who is female at birth is eligible to participate if they are
not pregnant or breastfeeding, and one of the following conditions applies
Is a participant of non-childbearing potential (PONCBP)
Or is a POCBP and using an acceptable contraceptive method during the study intervention period (at a minimum until after the last dose of study intervention)
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
For participants enrolled in France: a participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category

Exclusion Criteria

Any evidence of an active Center for Disease Control and Prevention (CDC) Stage 3 disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy
Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia
Presence of primary HIV-1 infection, evidenced by acute retroviral syndrome (e.g., fever, malaise, fatigue) and/or evidence of recent (within 3 months) documented viremia without antibody production and/or evidence of recent (within 3 months) documented seroconversion
Known history of liver cirrhosis with or without viral hepatitis co-infection
Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment)
History of ongoing or clinically relevant hepatitis within the previous 6 months
History of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation
Any history of significant underlying psychiatric disorder, in the opinion of the Investigator or ViiV Medical Monitor, including but not limited to schizophrenia, bipolar disorder with or without psychotic symptoms, other psychotic disorders, or schizotypal (personality) disorder or a clinical assessment of suicidality based on the responses on the Columbia-Suicide Severity Rating Scale (eCSSRS)
Any history of major depressive disorder with or without suicidal features, or anxiety disorders, that required medical intervention (pharmacologic or not) such as hospitalization or other inpatient treatment and/or chronic (>6 months) outpatient treatment
Any pre-existing physical or other psychiatric condition (including alcohol or drug abuse), which, in the opinion of the Investigator or ViiV Medical Monitor (with or without psychiatric evaluation), could interfere with the participant's ability to comply with the dosing schedule and protocol evaluations or which might compromise the safety of the participant
A pre-existing condition, in the opinion of the Investigator or ViiV Medical Monitor, that could interfere with normal gastrointestinal anatomy or motility (e.g., gastroesophageal reflux disease [GERD], gastric ulcers, gastritis, inflammatory bowel disease), hepatic and/or renal function, or with the absorption, metabolism, and/or excretion of the study drugs or render the participant unable to take oral study treatment
Myocardial infarction in the past 3 months
Familial or personal history of long QT syndrome or sudden cardiac death
Medical history, current or historical, of significant cardiac arrhythmias or Electrocardiogram (ECG) findings which, in the opinion of the Investigator or ViiV Medical Monitor, will interfere with the safety of the participant
Active Treatment for a viral infection other than HIV-1, such as Hepatitis B, with an agent that is active against HIV-1 (were known to be infected with HIV-1 after treatment for Hepatitis B was completed)
Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening
Treatment with any of the following agents within 28 days of Screening: radiation therapy, cytotoxic chemotherapeutic agents, any systemic immune suppressant
Participants receiving any protocol-prohibited medication and who are unwilling or unable to switch to an alternate medication
Participants who are unwilling to stop any medications as required by the local lab test for Helicobacter (H.) pylori
Participants who require concomitant medications known to be associated with a prolonged Corrected QT interval (QTc)
Exposure to an experimental drug, human blood product, monoclonal antibody, or vaccine (which does not have emergency, conditional or standard market authorization) within 28 days prior to the first dose of study treatment
Current enrollment or past participation within the last 30 days before signing of consent in any other clinical study involving an investigational study intervention (including an investigational Coronavirus Disease (COVID) vaccine) or any other type of medical research
Any evidence of viral resistance based on the NRTI backbone selected
Historical evidence (prior to study screening period) of the presence of resistanceassociated mutations gag A364V or A364A/V
Creatinine Clearance <50 mL/minute
Alanine aminotransferase (ALT) >=3 times upper limit of normal (ULN) or ALT >=2 times ULN and total bilirubin >=1.5 times ULN
Evidence of Hepatitis B virus (HBV) infection based on the results of testing for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and reflex HBV deoxyribonucleic acid (DNA) as follows
Participants positive for HBsAg are excluded
Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA on reflex testing are excluded
Positive Hepatitis C antibody test result at Screening and positive on reflex to Hepatitis C RNA
Positive test results for H. pylori
Known or suspected active COVID-19 infection or contact with an individual with known COVID-19, within 14 days of study enrollment
Untreated syphilis infection (positive rapid plasma reagin [RPR] at Screening) without documentation of treatment
Presence of moderate-to-severe hepatic impairment (Class B or C) as determined by Child-Pugh classification
Any acute laboratory abnormality at Screening, which, in the opinion of the investigator or ViiV Medical Monitor, would preclude participation in the study of an investigational compound
Urine Drug Screen positive (showing presence of): Amphetamines, Barbiturates, Cocaine, 3,4-Methyl enedioxy methamphetamine (MDMA) or Phencyclidine, or non-prescribed opiates, oxycodone, benzodiazepines, methadone, methamphetamines or tricyclic antidepressants
Any clinically relevant Grade 4 laboratory abnormality at Screen, including results for creatine phosphokinase (CPK), ALT, and lipid abnormalities that lack a compelling explanation from the Investigator
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 28 days
Exposure to more than 4 new investigational drugs or vaccines (exclusive of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) potential indication within 12 months prior to the first dosing day
Treatment with radiation therapy or cytotoxic chemotherapeutic agents or any systemic immunosuppressive agent within 30 days of study drug administration or anticipated need for such treatment within the study
ECG Heart Rate <50 beats per minute (bpm) or >100 bpm, or QT duration corrected for heart rate by Fridericia's formula (QTcF) >450 milliseconds (msec)
To assess any potential impact on participant eligibility with regard to safety, the Investigator must refer to the investigator's brochure (IB) and supplements, approved product labels, and/or local prescribing information for detailed information regarding warnings, precautions, contraindications, AEs, drug interactions, and other significant data pertaining to the study interventions
For Portugal only: HIV-2 infection (either determined by prior testing, medical history, or obtained locally during the Screening window)
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