This clinical research study will access the effectiveness (how well it works), safety, tolerability (how well the body stands the drug) and blood levels of combined doses of BMS-663068/GSK3684934, Raltegravir and Tenofovir.

A Phase IIb Randomized, Controlled, Partially-Blinded Trial to Investigate Safety, Efficacy and Dose-response of BMS-663068/GSK3684934 in Treatment-experienced HIV-1 Subjects, Followed by an Open-label Period on the Recommended Dose

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000437-36-DE

Enrollment

250

Registered

2011-07-18

Start date

2012-08-14

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human immunodeficiency virus type 1 (HIV-1)-infection MedDRA version: 19.0 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations

Interventions

Product Code: BMS-663068-03/GSK3684934 Pharmaceutical Form: Film-coated tablet CAS Number: 864953-39-9 Current Sponsor code: BMS-663068-03/GSK3684934

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Key inclusion criteria: Plasma HIV-1 RNA = 1000 copies/ml Men and women At least 18 years of age, (or minimum age as determined by local regulatory or as legal requirements dictate, whichever is higher) Antiretroviral treatment-experienced as defined in this protocol Susceptibility to study drugs by genotype/phenotype/PhenoSense® Entry (AI) CD4+ T-cell count > 50 cells/mm3 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Key exclusion criteria: Chronic HBV/HCV infection Contraindications to any of study drugs History of resistance to any component of the study regimen (TDF, ATV, RAL)

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of four doses of BMS-663068/GSK3684934 by determining the proportion of subjects with plasma HIV-1 RNA < 50 c/mL at Week 24 To assess the safety of four doses of BMS-663068/GSK3684934 in treatment-experienced HIV-1-infected subjects through Week 24 by measuring frequency of SAEs, and AEs leading to discontinuations. ; Secondary Objective: To assess the efficacy of four doses of BMS-663068/GSK3684934 by determining the proportion of subjects with plasma HIV-1 RNA < 50 c/mL at Week 48 and at Week 96 To assess the safety of four doses of BMS-663068/GSK3684934 in treatment-experienced HIV-infected subjects through Weeks 48 and 96 by measuring frequency of SAEs and AEs leading to discontinuations To assess the immunologic activity of BMS-663068/GSK3684934 based on change from baseline in CD4+ T-cell count at Weeks 24, 48, and 96 To assess the emergence of antiretroviral drug resistance in virus among subjects with virologic failure (VF) through Weeks 24, 48 and 96. ; Primary end point(s): Proportion of subjects with plasma HIV-1 RNA < 50 c/mL at Week 24; Frequency of SAEs and discontinuations due to AEs through Week 24. ;Timepoint(s) of evaluation of this end point: Week 24	—

Measure

Time frame

Main Objective: To assess the efficacy of four doses of BMS-663068/GSK3684934 by determining the proportion of subjects with plasma HIV-1 RNA < 50 c/mL at Week 24 To assess the safety of four doses of BMS-663068/GSK3684934 in treatment-experienced HIV-1-infected subjects through Week 24 by measuring frequency of SAEs, and AEs leading to discontinuations. ; Secondary Objective: To assess the efficacy of four doses of BMS-663068/GSK3684934 by determining the proportion of subjects with plasma HIV-1 RNA < 50 c/mL at Week 48 and at Week 96 To assess the safety of four doses of BMS-663068/GSK3684934 in treatment-experienced HIV-infected subjects through Weeks 48 and 96 by measuring frequency of SAEs and AEs leading to discontinuations To assess the immunologic activity of BMS-663068/GSK3684934 based on change from baseline in CD4+ T-cell count at Weeks 24, 48, and 96 To assess the emergence of antiretroviral drug resistance in virus among subjects with virologic failure (VF) through Weeks 24, 48 and 96. ; Primary end point(s): Proportion of subjects with plasma HIV-1 RNA < 50 c/mL at Week 24; Frequency of SAEs and discontinuations due to AEs through Week 24. ;Timepoint(s) of evaluation of this end point: Week 24

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Secondary

Measure	Time frame
Secondary end point(s): Proportion of subjects with plasma HIV-1 RNA < 50 c/mL at Weeks 48 and 96; Frequency of SAEs and discontinuations due to AEs through Weeks 48 and 96; Changes from baseline in CD4+ T-cell count at Weeks 24, 48 and 96; Frequency of newly-emergent genotypic substitutions and IC50 fold changes from baseline among subjects with virologic failure through Weeks 24, 48 and 96. ;Timepoint(s) of evaluation of this end point: Weeks 24, 48 and 96	—

Measure

Time frame

Secondary end point(s): Proportion of subjects with plasma HIV-1 RNA < 50 c/mL at Weeks 48 and 96; Frequency of SAEs and discontinuations due to AEs through Weeks 48 and 96; Changes from baseline in CD4+ T-cell count at Weeks 24, 48 and 96; Frequency of newly-emergent genotypic substitutions and IC50 fold changes from baseline among subjects with virologic failure through Weeks 24, 48 and 96. ;Timepoint(s) of evaluation of this end point: Weeks 24, 48 and 96

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Countries

Germany, Romania, Spain

Contacts

Public ContactClinical Trials HelpDesk

GlaxoSmithKline Research & Development Ltd

GSKClinicalSupportHD@gsk.com+442089904466

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026