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Integrase Inhibitor

GSK3640254 for Human Immunodeficiency Virus Infection (DYNAMIC Trial)

Q: What hazards are associated with GSK3640254 consumption?

GSK3640254 is ranked a 2 on our safety scale, indicating that there is some evidence of its security but not yet of its effectiveness.

Q: What other scientific experiments have been conducted involving GSK3640254?

GSK3640254 was first examined in 2002 at the University of Zurich, and there have been 285 studies completed since then. Currently, 49 trials are running with a bulk of them occurring near Fort Pierce, <a href="https://www.withpower.com/clinical-trials/georgia">Georgia</a>.

Q: Is there an active recruitment process for this clinical research?

According to information hosted on clinicaltrials.gov, the recruitment for this trial has concluded as of November 28th 2022. The initial post went live in August 2021 - however there are an abundance of other trials seeking participation at present.

Q: Are there any Canadian medical centers conducting this clinical experiment?

Presently, 20 medical centres are recruiting participants for this trial. Sites span from Fort Pierce to Decatur and Macon, as well as a variety of other cities. It is recommended that prospective patients choose the closest clinic in order to reduce transportation pressures associated with participation.

Q: How many individuals are currently enrolled in this clinical evaluation?

Unfortunately, no more participants are being accepted for this trial; it was first posted on August 18th 2021 and has since been updated November 28th 2022. If you're seeking other studies to join, there exist 485 trials recruiting patients with <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a> infections as well as 49 clinical trials actively enrolling subjects taking GSK3640254.

Phase 2

Waitlist Available

Research Sponsored by ViiV Healthcare

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at weeks 2, 4, 8, 12 (pre dose), 12 (2-6hr post dose), 24 (pre dose), 24 (2-6hr post dose)

Awards & highlights

DYNAMIC Trial Summary

This trial is comparing the effectiveness of a new HIV drug, GSK3640254, to the current standard of care, lamivudine, in treatment-naïve patients.

DYNAMIC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at weeks 2, 4, 8, 12 (pre dose), 12 (2-6hr post dose), 24 (pre dose), 24 (2-6hr post dose)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at weeks 2, 4, 8, 12 (pre dose), 12 (2-6hr post dose), 24 (pre dose), 24 (2-6hr post dose)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at weeks 2, 4, 8, 12 (pre dose), 12 (2-6hr post dose), 24 (pre dose), 24 (2-6hr post dose) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (c/mL) at Week 24

Secondary outcome measures

Absolute Values of Cluster of Differentiation 4+ (CD4+) T-cell Counts Through Week 24

Absolute Values of HIV-1 RNA Through Week 24

Change From Baseline in CD4+ T-cell Counts Through Week 24

+7 more

Side effects data

From 2020 Phase 2 trial • 34 Patients • NCT03784079

17%

Vomiting

17%

Lymphadenopathy

17%

Alanine aminotransferase increased

17%

Chromaturia

17%

Diarrhoea

17%

Insulin resistance

17%

Hyperglycaemia

17%

Nausea

17%

Myocarditis

17%

Meningococcal infection

17%

Vitamin D deficiency

17%

Spinal pain

17%

Aspartate aminotransferase increased

17%

Congestive cardiomyopathy

100%

80%

60%

40%

20%

Study treatment Arm

Part 1: GSK3640254 10 mg

Part 2: Placebo

Part 1: Placebo

Part 2: GSK3640254 40 mg

Part 2: GSK3640254 80 mg

Part 2: GSK3640254 140 mg

Part 1: GSK3640254 200 mg

DYNAMIC Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: GSK3640254 200 mg + DTG 50 mgExperimental Treatment2 Interventions

Participants with HIV-1 orally received high dose (200 mg) GSK3640254 tablet blinded and 50 mg DTG unblinded. Each participant received one tablet per day of each intervention up to Week 24.

Group II: GSK3640254 150 mg + DTG 50 mgExperimental Treatment2 Interventions

Participants with HIV-1 orally received medium dose (150 mg) GSK3640254 tablet blinded and 50 mg DTG unblinded. Each participant received one tablet per day of each intervention up to Week 24.

Group III: GSK3640254 100 mg + Dolutegravir (DTG) 50 mgExperimental Treatment2 Interventions

Participants with human immunodeficiency virus type 1 (HIV-1) orally received low dose (100 mg) GSK3640254 tablet blinded and 50 mg DTG unblinded. Each participant received one tablet per day of each intervention up to Week 24.

Group IV: DTG 50 mg + Lamivudine (3TC) 300 mgActive Control3 Interventions

Participants with HIV-1 orally received unblinded 50 mg DTG one tablet and blinded 300 mg 3TC. Each participant received one capsule per day of each intervention up to Week 24.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GSK3640254

2019

Completed Phase 2

~320

Dolutegravir

2018

Completed Phase 4

~5970

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

ViiV HealthcareLead Sponsor

359 Previous Clinical Trials

468,458 Total Patients Enrolled

Syneos HealthOTHER

172 Previous Clinical Trials

68,369 Total Patients Enrolled

GSK Clinical TrialsStudy DirectorViiV Healthcare

3,595 Previous Clinical Trials

6,143,845 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What hazards are associated with GSK3640254 consumption?

"GSK3640254 is ranked a 2 on our safety scale, indicating that there is some evidence of its security but not yet of its effectiveness."

Answered by AI

What other scientific experiments have been conducted involving GSK3640254?

"GSK3640254 was first examined in 2002 at the University of Zurich, and there have been 285 studies completed since then. Currently, 49 trials are running with a bulk of them occurring near Fort Pierce, Georgia."

Answered by AI

Is there an active recruitment process for this clinical research?

"According to information hosted on clinicaltrials.gov, the recruitment for this trial has concluded as of November 28th 2022. The initial post went live in August 2021 - however there are an abundance of other trials seeking participation at present."

Answered by AI

Are there any Canadian medical centers conducting this clinical experiment?

"Presently, 20 medical centres are recruiting participants for this trial. Sites span from Fort Pierce to Decatur and Macon, as well as a variety of other cities. It is recommended that prospective patients choose the closest clinic in order to reduce transportation pressures associated with participation."

Answered by AI

How many individuals are currently enrolled in this clinical evaluation?

"Unfortunately, no more participants are being accepted for this trial; it was first posted on August 18th 2021 and has since been updated November 28th 2022. If you're seeking other studies to join, there exist 485 trials recruiting patients with HIV infections as well as 49 clinical trials actively enrolling subjects taking GSK3640254."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Clinical Trial of GSK3640254 + Dolutegravir (DTG) in Human Immunodeficiency Virus-1 Infected Treatment-naive Adults

2021. "A Clinical Trial of GSK3640254 + Dolutegravir (DTG) in Human Immunodeficiency Virus-1 Infected Treatment-naive Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04900038.