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 - DYNAMIC

ViiV Healthcare UK Limited0 sites85 target enrollmentJune 1, 2021

ConditionsHuman Immunodeficiency Virus Type-1 (HIV-1)MedDRA version: 20.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862 Therapeutic area: Diseases [C] - Virus Diseases [C02]

DrugsTivicay EPIVIR Epivir

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Human Immunodeficiency Virus Type-1 (HIV-1)
Sponsor: ViiV Healthcare UK Limited
Enrollment: 85
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 1, 2021

End Date

May 11, 2023

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ViiV Healthcare UK Limited

Eligibility Criteria

Inclusion Criteria

•1\. Participants must be 18 years of age inclusive, at the time of signing the informed consent.
•Type of Participant and Disease Characteristics:
•2\. Treatment\-naïve, defined as no ARVs (in combination or monotherapy) received after a known diagnosis of HIV\-1 infection;
•NOTE: Use of PrEP (prior to known HIV\-1 infection) is allowed and still meets inclusion. PrEP is used by individuals who are not infected with HIV\-1 but who are at high risk for acquiring the virus. PrEP alone is not sufficient to treat HIV and the use of PrEP is stopped if/when a diagnosis of HIV is made.
•3\. Documented HIV infection and Screening plasma HIV\-1 RNA \=1000 c/mL;
•4\. Screening CD4\+ T\-cell count \=250 cells/mm3;
•5\. Body weight \=50\.0 kg (110 lbs.) for men and \=45\.0 kg (99 lbs) for women and body mass index (BMI) \> 18\.5 kg/m2\. Calculations will utilize sex assigned at birth;
•Sex and Contraceptive/Barrier Requirements:
•6\. Male and female
•a. Participants who are male at birth: There are no contraceptive requirements for participants who are male at birth

Exclusion Criteria

•1\. 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;
•2\. 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;
•3\. Presence of primary HIV infection, evidenced by acute retroviral syndrome (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;
•4\. Known history of liver cirrhosis with or without viral hepatitis co\-infection;
•5\. 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)
•6\. History of ongoing or clinically relevant hepatitis within the previous 6 months;
•7\. History of drug or other allergy that, in the opinion of the investigator or Medical Monitor (MM), contraindicates their participation;
•8\. Any history of significant underlying psychiatric disorder, in the opinion of the Investigator or MM, 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 eCSSRS.
•9\. 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;
•10\. Any pre\-existing physical or other psychiatric condition (incl. alcohol/drug abuse), which, in the opinion of the Investigator or MM (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;