A Phase IIb, Randomized, Double-blind, Parallel-group Study to Assess the Efficacy, Safety, Tolerability, and Resistance Profile of GSK3640254 in Combination With Dolutegravir Compared to Dolutegravir Plus Lamivudine in HIV-1 Infected, Treatment-naïve Adults

TerminadoFase 2ClinicalTrials.gov

ID: NCT04900038Tipo: INTERVENTIONALInicio: 18 de ago de 2021Fin estimado: 11 de may de 2023

Enfermedades Infecciosas Alergia e Inmunología

Traducción no disponible, mostrando original

Resumen

The purpose of this study was to evaluate the efficacy of GSK3640254 + DTG relative to lamivudine (3TC) + DTG in treatment-naïve adult participants living with human immunodeficiency virus (HIV)-1. The participants were randomized to one of the three doses of blinded GSK3640254 (100, 150, or 200 milligrams \[mgs\]) or a reference arm of blinded 3TC-each in combination with open label DTG.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Body weight \>=50.0 kilograms (kg) (110 pounds \[lbs.\]) for men and \>=45.0 kg (99 lbs.) for women and body mass index (BMI) \>18.5 kilograms per meter\^2 (kg/meter square). Calculations will utilize sex assigned at birth.
Treatment-naive, defined as no anti-retrovirals (ARVs) (in combination or monotherapy) received after a known diagnosis of HIV-1 infection.
Documented HIV infection and Screening plasma HIV-1 RNA greater than or equal to (\>=)1000 c/mL.
Screening CD4+ T-cell count \>=250 cells per millimeter\^3 (cells/cubic millimeter).

Criterios de exclusión

Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 disease \[CDC, 2014\], except cutaneous Kaposi's sarcoma not requiring systemic therapy.
Presence of primary HIV infection, evidenced by acute retroviral syndrome (example \[e.g.\], fever, malaise, fatigue, etc.) and/or evidence of recent (within 3 months) documented viremia without antibody production and/or evidence of recent (within 3 months) documented seroconversion.
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.
Any history of significant underlying psychiatric disorder.
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.
A pre-existing condition, in the opinion of the Investigator or 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 interventions or render the participant unable to take oral study treatment.
Familial or personal history of long QT syndrome or sudden cardiac death.
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).
Participants who require concomitant medications known to be associated with a prolonged corrected QT (QTc) interval.
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.

Intervenciones

drug

Lamivudine tablets

3TC was available as 300 mg tablets administered orally as an unblinded treatment.

drug

GSK3640254

GSK3640254 was available as 25 mg or 100 mg tablets administered orally.

drug

Dolutegravir

DTG was available as 50 mg tablets administered orally.

drug

Lamivudine capsules

3TC was available as 300 mg capsules administered orally as a blinded treatment.

Ubicaciones

GSK Investigational Site

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

Patrocinadores

PrincipalViiV Healthcare

ColaboradorSyneos Health

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