CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

DolutegravirWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (4)

Name (Synonyms) Correlation
drug1079 FTC/TAF Wiki 1.00
drug1157 GSK3640254 Wiki 1.00
drug58 ABC/3TC Wiki 1.00
drug2122 Placebo Wiki 0.05

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D015658 HIV Infections NIH 0.32

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 A Phase IIb, Randomized, Partially Blind, Active Controlled, Dose-range Finding Study of GSK3640254 Compared to a Reference Arm of Dolutegravir, Each in Combination With Nucleoside Reverse Transcriptase Inhibitors, in HIV-1 Infected Antiretroviral Treatment-naive Adults

Infection with HIV-1 continues to be a serious health threat throughout the world, with more than 40 million individuals infected worldwide. The current standard of care treatment for HIV-1 is combination anti-retroviral therapy (cART) with recommendations to start regardless of cluster of differentiation 4 (CD4) plus (+) T-cell count, committing people living with HIV to lifelong, lifesaving therapy. However, the chronic exposure to cART has identified anti-retroviral (ARV)-associated long-term toxicities (central nervous system [CNS] or cardiovascular [CV]/metabolic effects, renal disease), creating a need to address and prevent these co-morbidities. GSK3640254 is a next-generation HIV-1 maturation inhibitor (MI) and has completed a short-term, monotherapy, proof of concept (POC) Phase 2a study. 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]), in approximately 240 treatment-naïve HIV-1 infected adults. The total study duration will be approximately 7 years.

NCT04493216 HIV Infections Drug: GSK3640254 Drug: ABC/3TC Drug: FTC/TAF Drug: Dolutegravir Drug: Placebo
MeSH:HIV Infections

Primary Outcomes

Description: Proportion of participants with plasma HIV-1 RNA <50 c/mL will be assessed at Week 24.

Measure: Proportion of participants with plasma HIV-1 RNA <50 c/mL at Week 24

Time: At Week 24

Secondary Outcomes

Description: Proportion of participants with plasma HIV-1 RNA <50 c/mL will be assessed at Weeks 48 and 96.

Measure: Proportion of participants with plasma HIV-1 RNA <50 c/mL at Weeks 48 and 96

Time: At Weeks 48 and 96

Description: Absolute values of HIV-1 RNA at Weeks 24, 48 and 96 will be assessed.

Measure: Absolute values of HIV-1 RNA at Weeks 24, 48 and 96

Time: At Weeks 24, 48 and 96

Description: Change from Baseline in level of plasma HIV-1 RNA at Weeks 24, 48 and 96 will be assessed.

Measure: Change from Baseline in plasma HIV-1 RNA at Weeks 24, 48 and 96 (c/mL)

Time: Baseline and Weeks 24, 48 and 96

Description: Absolute values of CD4+ cells at Weeks 24, 48, and 96 will be assessed.

Measure: Absolute values of CD4+ T-cell counts at Weeks 24, 48 and 96

Time: At Weeks 24, 48 and 96

Description: Change from Baseline in CD4+ cells at Weeks 24, 48 and 96 will be assessed.

Measure: Change from Baseline in CD4+ T-cell counts at Weeks 24, 48 and 96

Time: Baseline and Weeks 24, 48 and 96

Description: An AE is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. SAE is defined as any untoward medical occurrence that, at any dose; results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability or incapacity or is a congenital anomaly or birth defect or any other situation that require medical or scientific judgment. Number of participants with SAEs, death and AEs leading to treatment discontinuation will be assessed at Weeks 24, 48 and 96.

Measure: Number of participants with serious adverse events (SAEs), Deaths and adverse events (AEs) leading to treatment discontinuation at Weeks 24, 48 and 96

Time: At Weeks 24, 48 and 96

Description: An AE is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. Number of participants with AEs will be assessed at Weeks 24, 48 and 98.

Measure: Number of participants with AEs at Weeks 24, 48 and 96

Time: At Weeks 24, 48 and 96

Description: An AE is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. Severity of AEs will be assessed at Weeks 24, 48 and 96.

Measure: Severity of AEs at Weeks 24, 48 and 96

Time: At Weeks 24, 48 and 96

Description: Number of participants with AEs in GI, Psych/CNS will be assessed at Weeks 24, 48 and 96.

Measure: Number of participants with AEs in Gastrointestinal (GI), Psychological (Psych)/Central nervous system (CNS) at Weeks 24, 48 and 96

Time: At Weeks 24, 48 and 96

Description: Plasma samples will be collected for analyzing phenotypic resistance at Weeks 24, 48 and 96 using PhenoSense genotype testing (GT) for reverse transcriptase (RT) (NRTI and non-nucleoside reverse transcriptase inhibitors [NNRTI]) and Protease inhibitor (PI), PhenoSense Integrase, PhenoSense Gag assays for GSK3640254.

Measure: Number of participants who develop phenotypic resistance at Weeks 24, 48 and 96

Time: At Weeks 24, 48 and 96

Description: Plasma samples will be collected for analyzing genotypic resistance at Weeks 24, 48 and 96 using PhenoSense GT for RT and Protease genotype, GeneSeq Integrase, and Gag genotype (using a Next Generation Sequencing platform).

Measure: Number of participants who develop genotypic resistance at Weeks 24, 48 and 96

Time: At Weeks 24, 48 and 96

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3640254 at Week 24.

Measure: Maximum observed concentration (Cmax) of GSK3640254 at steady state at Week 24

Time: At Week 24

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3640254 at Week 48.

Measure: Cmax of GSK3640254 at steady state at Week 48

Time: At Week 48

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3640254 at Week 24.

Measure: AUC over the dosing interval (AUC [0-tau]) of GSK3640254 at Week 24

Time: At Week 24

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3640254 at Week 48.

Measure: AUC (0-tau) of GSK3640254 at steady state at Week 48

Time: At Week 48

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3640254 at Week 24.

Measure: Plasma concentration at the end of the dosing (Ctau) of GSK3640254 at steady state at Week 24

Time: At Week 24

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of GSK3640254 at Week 48.

Measure: Ctau of GSK3640254 at steady state at Week 48

Time: At Week 48

No related HPO nodes (Using clinical trials)