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HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections

Primary Purpose

Infection, Human Immunodeficiency Virus

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

BMS-663068 400 mg

BMS-663068 800 mg

BMS-663068 600 mg

BMS-663068 1200 mg

Raltegravir 400 mg

Tenofovir 300 mg

Ritonavir 100 mg

Atazanavir 300 mg

About this trial

This is an interventional treatment trial for Infection, Human Immunodeficiency Virus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Plasma HIV-1 RNA ≥ 1000 copies/ml at Screening
Treatment experience with antiretroviral therapies (excluding integrase inhibitors)
Screening PHENOSENSE Entry indicating BMS-626529 inhibitory concentration (IC)50 < 0.1 μM
Cluster of differentiation (CD)4+ T-cell count > 50 cells/mm3

Exclusion Criteria:

History (or evidence at Screening) of genotypic resistance to any component of the study regimen [ Tenofovir Disoproxil Fumarate (TDF), Atazanavir (ATV), Raltegravir (RAL)]
Certain laboratory and electrocardiogram (ECG) values

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: BMS-663068 (400mg) + Raltegravir + Tenofovir

Arm B: BMS-663068 (800 mg) + Raltegravir + Tenofovir

Arm C: BMS-663068 (600 mg) + Raltegravir + Tenofovir

Arm D: BMS-663068 (1200 mg) + Raltegravir + Tenofovir

Arm E: Atazanavir + Ritonavir + Raltegravir + Tenofovir

Arm Description

Treatment Group 1

Treatment Group 2

Treatment Group 3

Treatment Group 4

Treatment Group 1 (reference arm)

Outcomes

Primary Outcome Measures

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

Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 24 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to evaluate the antiviral activity. Treatment comparisons were not performed as this was an estimation study. Response rates were tabulated by treatment arm with exact Clopper-Pearson binomial 95 percentage confidence intervals (CI). Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the snapshot window of the visit of interest. Intent-To-Treat-Exposed (ITT-E) Population includes all randomized participants who received at least one dose of study treatment.

Number of Participants With Serious Adverse Events (SAE) and Discontinuation Due to AEs up to Week 24

Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. Safety population included all participants who received at least one dose of study treatment. Summaries of SAEs and AEs leading to discontinuation or withdrawal through Week 24 included AEs with onset on or after the start of study treatment (i.e. study date of first study treatment intake) up to and including the end of the Week 24 visit snapshot window.

Secondary Outcome Measures

Change From Monotherapy Baseline in log10 HIV RNA of the Monotherapy Period

Change from monotherapy Baseline in log10 HIV RNA to assess the antiviral activity of temsavir following administration of selected doses of FTR administered orally to HIV-1-infected participants for 7 days. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as value at indicated time point minus Baseline value. ITT-E Monotherapy Population comprised of participants that were randomized and participated in the monotherapy sub-study and received at least one dose of FTR Monotherapy. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Maximum Decrease From Monotherapy Baseline in log10 Plasma HIV-1 RNA

Maximum decrease from monotherapy Baseline in log10 plasma HIV-1 RNA during monotherapy to assess the antiviral activity of temsavir following administration of selected doses of FTR administered orally to HIV-1-infected participants for 7 days. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as value at indicated time point minus Baseline value. The data for monotherapy nadir has been presented where nadir represents the maximum decrease from Baseline.

Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Day 8 of the Monotherapy Period

Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Baseline of combination therapy was assessed to evaluate the antiviral activity of four doses of FTR. Baseline of combination therapy was the Day 1 of the combination therapy. Virologic success or failure was determined using the non-missing viral load value at Baseline of combination therapy. The assessment closest to the window target Study Day was used for the analysis. Only those participants with data available at the specified time points were analyzed.

Number of Participants With SAE and Discontinuation Due to AEs During Monotherapy Period

Change From Monotherapy Baseline in Cluster of Differentiation (CD)4+ and CD8+ T-cell Counts During Monotherapy

Blood was collected and CD4+ and CD8+ cell count assessment was done by flow cytometery and was carried out at Baseline (Day 1) to evaluate the immunological activity of multiple doses of FTR. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and the values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed.

Change From Monotherapy Baseline in CD4+ and CD8+ T-cell Proportion During Monotherapy

Blood was collected and CD4+ and CD8+ proportion assessment was done by flow cytometery and was carried out at Baseline (Day 1) to evaluate the immunological activity of multiple doses of FTR. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and the values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed.

Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Primary Study

Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Weeks 48 and 96 using the FDA snapshot algorithm was assessed to evaluate the antiviral activity. Treatment comparisons were not performed as this was an estimation study. Response rates were tabulated by treatment arm with exact Clopper-Pearson binomial 95 percentage CI. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the snapshot window of the visit of interest.

Number of Participants With SAE and Discontinuation Due to AEs During Primary Study

Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. Safety Population comprised of participants who received at least one dose of study treatment. Summaries of SAEs and AEs leading to discontinuation or withdrawal through Week X (where X = 48 or 96) included AEs with onset on or after the start of study treatment (i.e. study date of first study treatment intake) up to and including the end of the Week 48 and 96 visit snapshot window.

Change From Baseline in CD4+ T-cell Count

Blood was collected and CD4+ cell count assessment by flow cytometery was carried out at Baseline (Day 1), Weeks 24, 48 and 96 to evaluate the immunological activity of multiple doses of BMS-663068/GSK3684934. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Number of Participants With Newly-emergent Genotypic Substitutions at Week 24

Participants who administered antiretroviral (ARV) with virologic failure (VF) were assessed. Genotypic substitution included assessment of Reverse Transcriptase (RT) substitution, Protease Inhibitor (PI) substitution and Integrase RAL substitution as per International Acquired Immune Deficiency Syndrome (AIDS) Society-USA (IAS-USA) list. ITT-E Resistance Tested through Week 24 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 24 Snapshot analysis window. The criteria for resistance tested was participant who had virologic failure or met the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA < 50 c/mL) and have confirmed plasma HIV-1 RNA >= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA < 50 c/mL) after Week 8 with last plasma HIV-1 RNA >=400 c/mL.

Number of Participants With Newly-emergent Genotypic Substitutions at Week 48

Participants who administered ARV with VF were assessed. Genotypic substitution included assessment of RT substitution, PI substitution and Integrase RAL substitution as per IAS-USA list. ITT-E Resistance Tested through Week 48 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 48 Snapshot analysis window. The criteria for resistance tested was participant who had virologic failure or the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA < 50 c/mL) and have confirmed plasma HIV-1 RNA >= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA < 50 c/mL) after Week 8 with last plasma HIV-1 RNA >=400 c/mL.

Number of Participants With Newly-emergent Genotypic Substitutions at Week 96

Participants who administered ARV with VF were assessed. Genotypic substitution included assessment of RT substitution, PI substitution and Integrase RAL substitution as per IAS-USA list. ITT-E Resistance Tested through Week 96 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 96 Snapshot analysis window. The criteria for resistance tested was participants with virologic failure or the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA < 50 c/mL) and have confirmed plasma HIV-1 RNA >= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA < 50 c/mL) after Week 8 with last plasma HIV-1 RNA >=400 c/mL.

Maximum Change From Baseline in Inhibitory Concentration at 50% (IC50) Fold Change Among Participants With VF at Week 24

Virologic failure is defined clinically as confirmed plasma HIV-1 RNA >= 50 copies/mL at Week 24 or later or virologic rebound defined as confirmed HIV-1 RNA >=50 copies/mL at any time after prior confirmed suppression to <50 copies/mL OR confirmed >1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was >= 50 copies/mL . The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed.

Change From Baseline in IC50 Fold Change Among Participants With VF at Week 48

Virologic failure is defined clinically as confirmed plasma HIV-1 RNA >= 50 copies/mL at Week 24 or later or later or virologic rebound defined as confirmed HIV-1 RNA >=50 copies/mL at any time after prior confirmed suppression to <50 copies/mL OR confirmed >1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was >= 50 copies/mL. The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed.

Change From Baseline in IC50 Fold Change Among Participants With VF at Week 96

Virologic failure is defined clinically as confirmed plasma HIV-1 RNA >= 50 copies/mL at Week 24 or later or virologic rebound defined as confirmed HIV-1 RNA >=50 copies/mL at any time after prior confirmed suppression to <50 copies/mL OR confirmed >1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was >= 50 copies/mL. The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed.

Full Information

NCT ID

NCT01384734

First Posted

June 23, 2011

Last Updated

October 16, 2018

Sponsor

ViiV Healthcare

1. Study Identification

Unique Protocol Identification Number

NCT01384734

Brief Title

HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

July 26, 2011 (Actual)

Primary Completion Date

February 18, 2013 (Actual)

Study Completion Date

May 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ViiV Healthcare

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to assess the safety, efficacy, tolerability and pharmacokinetics of four doses of BMS-663068 with Raltegravir (RAL) + Tenofovir Disoproxil Fumarate (TDF). At least 1 dose of BMS-663068 can be identified which is safe, well tolerated, and efficacious when combined with RAL + TDF for treatment-experienced HIV-1 infected subjects. PHENOSENSE® is a registered trademark of Monogram Biosciences.

Detailed Description

Masking: Double-blind for BMS-6630368 treatment groups until the Week 24 Primary Endpoint analysis, then open label. The reference groups is all open-label. Arms: 5 (4 BMS-663068 treatment groups and 1 reference group) Intervention Model: Parallel (with unblinding after the Week 24 primary endpoint analysis)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infection, Human Immunodeficiency Virus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

254 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A: BMS-663068 (400mg) + Raltegravir + Tenofovir

Arm Type

Experimental

Arm Description

Treatment Group 1

Arm Title

Arm B: BMS-663068 (800 mg) + Raltegravir + Tenofovir

Arm Type

Experimental

Arm Description

Treatment Group 2

Arm Title

Arm C: BMS-663068 (600 mg) + Raltegravir + Tenofovir

Arm Type

Experimental

Arm Description

Treatment Group 3

Arm Title

Arm D: BMS-663068 (1200 mg) + Raltegravir + Tenofovir

Arm Type

Experimental

Arm Description

Treatment Group 4

Arm Title

Arm E: Atazanavir + Ritonavir + Raltegravir + Tenofovir

Arm Type

Active Comparator

Arm Description

Treatment Group 1 (reference arm)

Intervention Type

Drug

Intervention Name(s)

BMS-663068 400 mg

Intervention Description

Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

Intervention Type

Drug

Intervention Name(s)

BMS-663068 800 mg

Intervention Description

Tablets, Oral, 800 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

Intervention Type

Drug

Intervention Name(s)

BMS-663068 600 mg

Intervention Description

Tablets, Oral, 600 mg, once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

Intervention Type

Drug

Intervention Name(s)

BMS-663068 1200 mg

Intervention Description

Tablets, Oral, 1200 mg, once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

Intervention Type

Drug

Intervention Name(s)

Raltegravir 400 mg

Intervention Description

Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

Intervention Type

Drug

Intervention Name(s)

Tenofovir 300 mg

Intervention Description

Tablets, Oral, 300 mg, Once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose

Intervention Type

Drug

Intervention Name(s)

Ritonavir 100 mg

Intervention Description

Tablets, Oral, 100 mg, Once daily, 96 weeks

Intervention Type

Drug

Intervention Name(s)

Atazanavir 300 mg

Intervention Description

Capsules, Oral, 300 mg, Once daily, 96 weeks

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Week 24

Title

Number of Participants With Serious Adverse Events (SAE) and Discontinuation Due to AEs up to Week 24

Description

Time Frame

Up to Week 24

Secondary Outcome Measure Information:

Title

Change From Monotherapy Baseline in log10 HIV RNA of the Monotherapy Period

Description

Time Frame

Baseline and up to Day 8 of the monotherapy period

Title

Maximum Decrease From Monotherapy Baseline in log10 Plasma HIV-1 RNA

Description

Time Frame

Baseline and up to Day 8 of the monotherapy period

Title

Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Day 8 of the Monotherapy Period

Description

Time Frame

Up to Day 8 of the monotherapy period

Title

Number of Participants With SAE and Discontinuation Due to AEs During Monotherapy Period

Description

Time Frame

Up to Day 8 of the monotherapy period

Title

Change From Monotherapy Baseline in Cluster of Differentiation (CD)4+ and CD8+ T-cell Counts During Monotherapy

Description

Time Frame

Baseline and Day 8

Title

Change From Monotherapy Baseline in CD4+ and CD8+ T-cell Proportion During Monotherapy

Description

Time Frame

Baseline and Day 8

Title

Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Primary Study

Description

Time Frame

Weeks 48 and 96

Title

Number of Participants With SAE and Discontinuation Due to AEs During Primary Study

Description

Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. Safety Population comprised of participants who received at least one dose of study treatment. Summaries of SAEs and AEs leading to discontinuation or withdrawal through Week X (where X = 48 or 96) included AEs with onset on or after the start of study treatment (i.e. study date of first study treatment intake) up to and including the end of the Week 48 and 96 visit snapshot window.

Time Frame

Weeks 48 and 96

Title

Change From Baseline in CD4+ T-cell Count

Description

Time Frame

Baseline and Weeks 24, 48 and 96

Title

Number of Participants With Newly-emergent Genotypic Substitutions at Week 24

Description

Time Frame

Up to Week 24

Title

Number of Participants With Newly-emergent Genotypic Substitutions at Week 48

Description

Time Frame

Up to Week 48

Title

Number of Participants With Newly-emergent Genotypic Substitutions at Week 96

Description

Participants who administered ARV with VF were assessed. Genotypic substitution included assessment of RT substitution, PI substitution and Integrase RAL substitution as per IAS-USA list. ITT-E Resistance Tested through Week 96 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 96 Snapshot analysis window. The criteria for resistance tested was participants with virologic failure or the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA < 50 c/mL) and have confirmed plasma HIV-1 RNA >= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA < 50 c/mL) after Week 8 with last plasma HIV-1 RNA >=400 c/mL.

Time Frame

Up to Week 96

Title

Maximum Change From Baseline in Inhibitory Concentration at 50% (IC50) Fold Change Among Participants With VF at Week 24

Description

Time Frame

Baseline and up to Week 24

Title

Change From Baseline in IC50 Fold Change Among Participants With VF at Week 48

Description

Time Frame

Baseline and up to Week 48

Title

Change From Baseline in IC50 Fold Change Among Participants With VF at Week 96

Description

Virologic failure is defined clinically as confirmed plasma HIV-1 RNA >= 50 copies/mL at Week 24 or later or virologic rebound defined as confirmed HIV-1 RNA >=50 copies/mL at any time after prior confirmed suppression to <50 copies/mL OR confirmed >1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was >= 50 copies/mL. The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed.

Time Frame

Baseline and up to Week 96

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Plasma HIV-1 RNA ≥ 1000 copies/ml at Screening Treatment experience with antiretroviral therapies (excluding integrase inhibitors) Screening PHENOSENSE Entry indicating BMS-626529 inhibitory concentration (IC)50 < 0.1 μM Cluster of differentiation (CD)4+ T-cell count > 50 cells/mm3 Exclusion Criteria: History (or evidence at Screening) of genotypic resistance to any component of the study regimen [ Tenofovir Disoproxil Fumarate (TDF), Atazanavir (ATV), Raltegravir (RAL)] Certain laboratory and electrocardiogram (ECG) values

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

ViiV Healthcare

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94102

Country

United States

Facility Name

GSK Investigational Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

GSK Investigational Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20009

Country

United States

Facility Name

GSK Investigational Site

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

GSK Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32803

Country

United States

Facility Name

GSK Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30312

Country

United States

Facility Name

GSK Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10008

Country

United States

Facility Name

GSK Investigational Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

GSK Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267-0405

Country

United States

Facility Name

GSK Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

GSK Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

GSK Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

GSK Investigational Site

City

Longview

State/Province

Texas

ZIP/Postal Code

75605

Country

United States

Facility Name

GSK Investigational Site

City

Ciudad de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1202ABB

Country

Argentina

Facility Name

GSK Investigational Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

2000

Country

Argentina

Facility Name

GSK Investigational Site

City

Buenos Aires

ZIP/Postal Code

C1141ACG

Country

Argentina

Facility Name

GSK Investigational Site

City

Buenos Aires

ZIP/Postal Code

C1426EGR

Country

Argentina

Facility Name

GSK Investigational Site

City

Córdoba

ZIP/Postal Code

X5000JJS

Country

Argentina

Facility Name

GSK Investigational Site

City

Rosario

ZIP/Postal Code

S2000CXP

Country

Argentina

Facility Name

GSK Investigational Site

City

Bogota

Country

Colombia

Facility Name

GSK Investigational Site

City

Bogoto

Country

Colombia

Facility Name

GSK Investigational Site

City

Bogotá

Country

Colombia

Facility Name

GSK Investigational Site

City

Bonn

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

53127

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

12157

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

20099

Country

Germany

Facility Name

GSK Investigational Site

City

München

ZIP/Postal Code

80336

Country

Germany

Facility Name

GSK Investigational Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44280

Country

Mexico

Facility Name

GSK Investigational Site

City

Zapopan

State/Province

Jalisco

ZIP/Postal Code

45170

Country

Mexico

Facility Name

GSK Investigational Site

City

San Luis Potosi

State/Province

San Luis Potosí

ZIP/Postal Code

78240

Country

Mexico

Facility Name

GSK Investigational Site

City

Aguascalientes

ZIP/Postal Code

20230

Country

Mexico

Facility Name

GSK Investigational Site

City

ZIP/Postal Code

14000

Country

Mexico

Facility Name

GSK Investigational Site

City

Distrito Federal

ZIP/Postal Code

03720

Country

Mexico

Facility Name

GSK Investigational Site

City

Mexico City

ZIP/Postal Code

3100

Country

Mexico

Facility Name

GSK Investigational Site

City

Iquitos

State/Province

Loreto

ZIP/Postal Code

Iqui 01

Country

Peru

Facility Name

GSK Investigational Site

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

GSK Investigational Site

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

GSK Investigational Site

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

GSK Investigational Site

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

GSK Investigational Site

City

Lima

ZIP/Postal Code

Lima 11

Country

Peru

Facility Name

GSK Investigational Site

City

Lima

ZIP/Postal Code

Lima 31

Country

Peru

Facility Name

GSK Investigational Site

City

Bucharest

ZIP/Postal Code

021105

Country

Romania

Facility Name

GSK Investigational Site

City

Constanta

ZIP/Postal Code

900709

Country

Romania

Facility Name

GSK Investigational Site

City

Craiova

Country

Romania

Facility Name

GSK Investigational Site

City

Iasi

ZIP/Postal Code

700116

Country

Romania

Facility Name

GSK Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

191167

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Smolensk

ZIP/Postal Code

214006

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St. Petersburg

ZIP/Postal Code

190103

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St. Petersburg

ZIP/Postal Code

196645

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Dundee

State/Province

KwaZulu- Natal

ZIP/Postal Code

3000

Country

South Africa

Facility Name

GSK Investigational Site

City

Durban

ZIP/Postal Code

4001

Country

South Africa

Facility Name

GSK Investigational Site

City

Johannesburg

ZIP/Postal Code

2010

Country

South Africa

Facility Name

GSK Investigational Site

City

Observatory, Cape Town

ZIP/Postal Code

7925

Country

South Africa

Facility Name

GSK Investigational Site

City

Badalona

ZIP/Postal Code

08916

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

GSK Investigational Site

City

Córdoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

27922453

Citation

Thompson M, Lalezari JP, Kaplan R, Pinedo Y, Pena OAS, Cahn P, Stock DA, Joshi SR, Hanna GJ, Lataillade M; AI438011 study team. Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in antiretroviral-experienced subjects: week 48 analysis of AI438011, a Phase IIb, randomized controlled trial. Antivir Ther. 2017;22(3):215-223. doi: 10.3851/IMP3112. Epub 2016 Dec 6.

Results Reference

derived

PubMed Identifier

26902761

Citation

Landry I, Zhu L, Abu Tarif M, Hruska M, Sadler BM, Pitsiu M, Joshi S, Hanna GJ, Lataillade M, Boulton DW, Bertz RJ. Model-Based Phase 3 Dose Selection for HIV-1 Attachment Inhibitor Prodrug BMS-663068 in HIV-1-Infected Patients: Population Pharmacokinetics/Pharmacodynamics of the Active Moiety, BMS-626529. Antimicrob Agents Chemother. 2016 Apr 22;60(5):2782-9. doi: 10.1128/AAC.02503-15. Print 2016 May.

Results Reference

derived

PubMed Identifier

26423650

Citation

Lalezari JP, Latiff GH, Brinson C, Echevarria J, Trevino-Perez S, Bogner JR, Thompson M, Fourie J, Sussmann Pena OA, Mendo Urbina FC, Martins M, Diaconescu IG, Stock DA, Joshi SR, Hanna GJ, Lataillade M; AI438011 study team. Safety and efficacy of the HIV-1 attachment inhibitor prodrug BMS-663068 in treatment-experienced individuals: 24 week results of AI438011, a phase 2b, randomised controlled trial. Lancet HIV. 2015 Oct;2(10):e427-37. doi: 10.1016/S2352-3018(15)00177-0. Epub 2015 Sep 1.

Results Reference

derived

PubMed Identifier

24128669

Citation

Zhou N, Nowicka-Sans B, McAuliffe B, Ray N, Eggers B, Fang H, Fan L, Healy M, Langley DR, Hwang C, Lataillade M, Hanna GJ, Krystal M. Genotypic correlates of susceptibility to HIV-1 attachment inhibitor BMS-626529, the active agent of the prodrug BMS-663068. J Antimicrob Chemother. 2014 Mar;69(3):573-81. doi: 10.1093/jac/dkt412. Epub 2013 Oct 14.

Results Reference

derived

Learn more about this trial

HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections

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HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections

Infection, Human Immunodeficiency Virus

About this trial

Eligibility Criteria

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

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Primary Outcome Measures

Secondary Outcome Measures

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1. Study Identification

2. Study Status

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4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial