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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02415595
Other study ID # 205891
Secondary ID 2013-005487-26AI
Status Terminated
Phase Phase 2
First received
Last updated
Start date May 12, 2015
Est. completion date August 21, 2017

Study information

Verified date August 2018
Source ViiV Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to find at least one dose of BMS-955176 that will be safe, effective and tolerable for HIV-1 infected treatment naive adults.


Recruitment information / eligibility

Status Terminated
Enrollment 210
Est. completion date August 21, 2017
Est. primary completion date May 26, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

- Men and non-pregnant women, at least 18 years of age

- Antiretroviral treatment-naïve; defined as no current or previous exposure to > 1 week of an antiretroviral drug

- Plasma HIV-1 RNA = 1000 copies/mL

- CD4 T-cell count > 200 cells/mm3

Exclusion Criteria:

- Resistance or partial resistance to any study drug determined by tests at Screening

- Current or historical genotypic and/or phenotypic drug resistance testing showing certain resistance mutations to EFV, TDF, FTC, Protease Inhibitors

- Chronic hepatitis B virus (HBV)/ hepatitis C virus (HCV)

- Blood tests that indicate normal liver function

- Hemoglobin < 8.0 g/dL, platelets < 50,000 cells/mm3

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BMS-955176
HIV Maturation Inhibitor
EFV
EFV
TDF/FTC
TDF/FTC

Locations

Country Name City State
Argentina GSK Investigational Site Buenos Aires
Argentina GSK Investigational Site Buenos Aires
Argentina GSK Investigational Site Ciudad Autonoma de Buenos Aires Buenos Aires
Argentina GSK Investigational Site Córdoba
Argentina GSK Investigational Site Rosario Santa Fe
Canada GSK Investigational Site Edmonton Alberta
Canada GSK Investigational Site Montreal Quebec
Canada GSK Investigational Site Montreal Quebec
Canada GSK Investigational Site Montreal Quebec
Canada GSK Investigational Site Montreal Quebec
Canada GSK Investigational Site Ottawa Ontario
Canada GSK Investigational Site Quebec
Canada GSK Investigational Site Winnipeg Manitoba
Chile GSK Investigational Site Santiago Región Metro De Santiago
Chile GSK Investigational Site Santiago
Chile GSK Investigational Site Santiago
France GSK Investigational Site Le Kremlin-Bicêtre
France GSK Investigational Site Lyon cedex 04
France GSK Investigational Site Nantes
France GSK Investigational Site Nice
France GSK Investigational Site Paris
France GSK Investigational Site Paris
France GSK Investigational Site Paris Cedex 10
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Bonn Nordrhein-Westfalen
Germany GSK Investigational Site Dortmund
Germany GSK Investigational Site Duesseldorf Nordrhein-Westfalen
Germany GSK Investigational Site Essen Nordrhein-Westfalen
Germany GSK Investigational Site Hannover Niedersachsen
Germany GSK Investigational Site Muenchen Bayern
Germany GSK Investigational Site Muenchen Bayern
Italy GSK Investigational Site Bergamo Lombardia
Italy GSK Investigational Site Milano Lombardia
Italy GSK Investigational Site Milano Lombardia
Italy GSK Investigational Site Monza Lombardia
Mexico GSK Investigational Site DF
Mexico GSK Investigational Site Durango
Mexico GSK Investigational Site Fracc. Las Americas Aguascalientes
Mexico GSK Investigational Site León Guanajuato
Mexico GSK Investigational Site Mexico City
Poland GSK Investigational Site Bydgoszcz
Poland GSK Investigational Site Szczecin
Poland GSK Investigational Site Warszawa
Poland GSK Investigational Site Wroclaw
South Africa GSK Investigational Site Bloemfontein Free State
Spain GSK Investigational Site Alcala de Henares
Spain GSK Investigational Site Badalona
Spain GSK Investigational Site Madrid
Spain GSK Investigational Site Madrid
Spain GSK Investigational Site Santiago de Compostela
United Kingdom GSK Investigational Site Edinburgh Midlothian
United Kingdom GSK Investigational Site London
United Kingdom GSK Investigational Site London
United Kingdom GSK Investigational Site London
United Kingdom GSK Investigational Site Tooting, London
United States GSK Investigational Site Atlanta Georgia
United States GSK Investigational Site Beverly Hills California
United States GSK Investigational Site Decatur Georgia
United States GSK Investigational Site DeLand Florida
United States GSK Investigational Site Fort Worth Texas
United States GSK Investigational Site Los Angeles California
United States GSK Investigational Site Santa Fe New Mexico
United States GSK Investigational Site Tulsa Oklahoma

Sponsors (2)

Lead Sponsor Collaborator
ViiV Healthcare GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Chile,  France,  Germany,  Italy,  Mexico,  Poland,  South Africa,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <40 Copies Per Milliliter (c/mL) at Week 24 Using Food and Drug Administration (FDA) Snapshot Algorithm Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV 1 RNA <40 c/mL at Week 24 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window (18 to 30 weeks) to determine response. Analysis was performed on mITT Population, which comprised of randomized participants who received at least 1 dose of BMS-955176/GSK3532795 or EFV. Week 24
Secondary Number of Participants With Plasma HIV-1 RNA < 40 c/mL at Weeks 48 and 96 Using FDA Snapshot Algorithm Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV 1 RNA <40 c/mL at Weeks 48 and 96 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window to determine response. The analysis was performed using mITT Population (observed), which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). The data was not collected for Week 96 analysis; as the study was terminated early. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles). Weeks 48 and 96
Secondary Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Week 24 Using FDA Snapshot Algorithm Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV-1 RNA <200 c/mL at Week 24 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window to determine response. Week 24
Secondary Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Weeks 48 and 96 Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV-1 RNA <200 c/mL at Weeks 48 and 96 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window to determine response. The analysis was performed using mITT Population (observed), which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). The data was not collected for Week 96 analysis; as the study was terminated early. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles). Weeks 48 and 96
Secondary Number of Participants With Newly Emergent Genotypic Resistance Using All On-treatment Isolates The emergence of genotypic resistance among samples selected for drug resistance testing were assessed by searching for all reverse transcriptase substitutions and protease inhibitor substitutions listed in the International Acquired Immunodeficiency Syndrome (AIDS) Society-United States of America (IAS-USA) list of HIV-1 drug resistance mutations. The outcome was originally designed to be assessed up to 96 weeks of treatment, but it was analyzed up to Week 24 as the study was terminated early. The emergence of genotypic resistance is presented for participants in the mITT Population who had Baseline and on-treatment genotypic resistance testing and who had successful sequencing. Week 24
Secondary Number of Participants With Newly Emergent Phenotypic Resistance Using All On-treatment Isolates Phenotypic resistance to a drug is defined as a fold change (i.e., ratio of the 50% inhibitory concentration (IC50) of the clinical isolate to the IC50 of the reference strain) which is greater than the cut-off for reduced susceptibility. Emergent phenotypic resistance to BMS-955176/GSK3532795 was defined as a Baseline fold change IC50<= 3 and an on-treatment fold change IC50>3. The number of participants with newly emergent phenotypic resistance is presented for participants in the mITT Population who had Baseline and on-treatment phenotypic resistance testing. The outcome was originally designed to be assessed up to 96 weeks of treatment, but it was analyzed up to Week 24 as the study was terminated early. Week 24
Secondary Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time Blood samples were collected for analysis of HIV-1 RNA. Values obtained at Day 1 were considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value. Change from Baseline in plasma HIV-1 RNA (log10) is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point. Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
Secondary Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time CD4+ T-cell counts was assessed using flow cytometry. Values obtained at Day 1 were considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value. Change from Baseline in CD4+T- cell counts is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point. Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
Secondary Change From Baseline in the Percentage of CD4+ T-cells Over Time CD4+ T-cell counts overall was assessed using flow cytometry. Values obtained at Day 1 were considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value. Change from Baseline in percentage of CD4+T- cell counts is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point. Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
Secondary Number of Participants With Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation (AELD) Any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention were categorized as SAE. Number of participants with SAEs and AELDs is summarized. Up to Week 96
Secondary Number of Participants With at Least One Centers for Disease Control (CDC) Class C Events The occurrence of new AIDS defining events that is CDC class C events is presented. Up to Week 96
Secondary Maximum Observed Plasma Concentration (Cmax), Observed Pre-dose Plasma Concentration (C0) and Observed Plasma Concentration at the End of a Dosing Interval (Ctau) of BMS-955176/GSK3532795 Serial blood samples were collected at indicated time points for intensive pharmacokinetic (PK) assessment. The PK assessments were performed on evaluable PK Population, a sub-population which included all treated participants who had adequate PK profiles. Pre-dose (morning) and at 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16)
Secondary Time of Maximum Observed Plasma Concentration (Tmax) of BMS-955176/GSK3532795 Serial blood samples were collected at indicated time points for intensive PK assessment. Pre-dose (morning) and 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16)
Secondary Area Under the Concentration-time Curve in One Dosing Interval (AUC [Tau]) of BMS-955176/GSK3532795 Serial blood samples were collected at indicated time points for intensive PK assessment. Pre-dose (morning) and at 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16)
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