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A Study to Assess Dolutegravir in HIV-infected Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen. (VIKING-3)

Primary Purpose

Infection, Human Immunodeficiency Virus

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

dolutegravir

About this trial

This is an interventional treatment trial for Infection, Human Immunodeficiency Virus focused on measuring GSK1349572, resistance to raltegravir or elvitegravir, Integrase inhibitor, ART-experienced, dolutegravir

Eligibility Criteria

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

Inclusion Criteria:

Screening plasma HIV-1 RNA ≥500 copies/mL
ART-experienced, INI-experienced, DTG naïve
Experienced virological failure on raltegravir (RAL) or elvitegravir (ELV) regimen
The subject's HIV-1 shows resistance to RAL or ELV at Screening or at prior time point of virological failure on RAL or ELV
Documented resistance to at least one drug from each of three or more of all approved classes of ART
Be able to receive at least one fully active drug as part of the OBR from Day 8
Women capable of becoming pregnant must use appropriate contraception during the study (as defined by the protocol)
Willing and able to understand and provide signed and dated written informed consent prior to Screening.

Exclusion Criteria:

Women who are pregnant or breast feeding
An active AIDS-defining condition at Screening (except cutaneous Kaposi's sarcoma not requiring systemic therapy or CD4+ <200c/mm3)
Moderate to severe hepatic impairment as defined by Child-Pugh classification
Anticipated need for HCV therapy during the first 24 weeks of the study
Recent history of any upper or lower gastrointestinal bleed, with the exception of anal or rectal bleeding
Allergy or intolerance to the study drugs or their components or drugs of their class
Malignancy within the past 6 months
Treatment with an HIV-1 therapeutic vaccine within 90 days of Screening
Treatment with radiation therapy, cytotoxic chemotherapeutic agents or any immunomodulator within 28 days of Screening
Treatment with any agent, other than licensed ART, with documented activity against HIV-1 in vitro within 28 days of first dose of investigational product
Treatment with etravirine, efavirenz, or nevirapine within 14 days of Day 1(etravirine may be used if coadministered with lopinivir/ritonavir or darunavir/ritonavir)
Treatment with tipranivir/ritonavir, fosamprenavir, or fosamprenavir/ritonavir within 28 days prior to Screening
Verified Grade 4 laboratory abnormality at Screening
ALT> 5 times the upper limit of normal (ULN) at Screening
ALT ≥ 3X ULN and bilirubin > 1.5 X ULN (with 35% direct bilirubin) at Screening

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

dolutegravir

Arm Description

dolutegravir plus background antiretroviral therapy optimised at Day 8

Outcomes

Primary Outcome Measures

Mean Change From Baseline in Plasma HIV-1 RNA at Day 8

Mean change from Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Day 8 was calculated as the Day 8 value minus the Baseline value. The last observation was carried forward if a participant had missed the Day 8 visit. The Baseline observation was carried forward if a participant had discontinued the treatment before Day 8. Blood samples for assessment of HIV-1 RNA levels were collected at Baseline and Day 8.

Number of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 24

The number of participants who had viral load <50 copies/mL at Week 24 based on the Food and Drug Administration's Snapshot algorithm was assessed. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI [due to missing data/discontinuation of investigational product prior to the visit window]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the VOI analysis window.

Number of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 48

The number of participants who had viral load <50 copies/mL at Week 48 based on the Food and Drug Administration's Snapshot algorithm was assessed. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI [due to missing data/discontinuation of investigational product prior to the visit window]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the VOI analysis window.

Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury.

Number of Participants With Adverse Events of the Indicated Severity, Per the Division of Acquired Immune Deficiency Syndrome (DAIDS) Grading Scale

Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade

The severity of clinical chemistry toxicities was graded according to the DAIDS toxicity scale. The DAIDS displays events as Grades 1-5 based on this general guideline: Grade (G) 1, mild; G2, moderate; G3, severe; G4, life threatening; G5, death related to toxicity.

Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade

The severity of hematology toxicities was graded according to the DAIDS. The DAIDS displays events as Grades 1-5 based on this general guideline: Grade (G) 1, mild; G2, moderate; G3, severe; G4, life threatening; G5, death related to toxicity.

Secondary Outcome Measures

Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48

The number of participants with plasma HIV-1 RNA less than 400 and 50 copies (c)/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40 and 48 based on the Food and Drug Administration's Snapshot algorithm was assessed. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI [due to missing data/discontinuation of investigational product prior to the visit window]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the par. was on treatment within the VOI analysis window

Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion

The number of participants with plasma HIV-1 RNA less than 400 and 50 copies (c)/mL was assessed at Weeks 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168 and 180 using data of observed cases. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study Completion

Mean change from Baseline in plasma HIV-1 RNA was assesseed at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, 48 , 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, and 180 using data of the observed cases. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Absolute Values for CD4+ Cell Counts at Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 and for CD8+ Cell Counts at Baseline and Weeks 4, 12, 24, and 48

Absolute values for CD4+ cell counts were assessed at Baseline, Day 8 and Weeks 4, 8, 12, 16, and 24, and absolute values for CD8+ cell counts were assessed at Baseline and Weeks 4, 12, 24, and 48.

Median Change From Baseline in CD4+ Cell Counts at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks Until Study Completion

Median change from Baseline in CD4+ cell counts was assessed at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, and 180. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Ratio of CD4+/CD8+ Cell Count at Baseline and Weeks 4, 12, 24, and 48

The ratio of CD4+/CD8+ cell count (measured in cells/mm^3) was assessed at Baseline and at Weeks 4, 12, 24, and 48. The ratio was calculated as the CD4+ cell count divided by CD8+ cell count.

Number of Participants With HIV-1 Disease Progression (Acquired Immune Deficiency Syndrome [AIDS] or Death)

The number of participants with HIV-1 disease progression (AIDS or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).

Cmax and Ctau of DTG

The maximum plasma concentration (Cmax) and the concentration at the end of a dosing interval (Ctau) of DTG were assessed by a population pharmacokinetic (PK) modeling approach using pooled DTG PK data from multiple studies. For this study, blood samples for pharmacokinetic assessments were collected pre-dose on Day 8 and at Weeks 4 and 24, at 1-3 hours post-dose on Day 8, and at 1-3 hours or 4-12 hours post-dose at Weeks 4 and 24.

AUC(0-tau) and AUC(0-24) of DTG

The area under the time concentration curve over the dosing interval (AUC[0-tau]) and from 0 to 24 hours (AUC[0-24]) of DTG was assessed by a population PK modeling approach using pooled DTG PK data from multiple studies. For this study, blood samples for pharmacokinetic assessments were collected pre-dose on Day 8 and at Weeks 4 and 24, at 1-3 hours post-dose on Day 8, and at 1-3 hours or 4-12 hours post-dose at Weeks 4 and 24.

C0 Assessment of DTG

The plasma DTG concentration immediately prior to dosing at steady state (C0) was assessed at Day 8, Week 4, and Week 24. Blood samples for pharmacokinetic assessments were collected pre-dose and 1-3 hours post-dose on Day 8 and at Week 4 and 4-12 hours post-dose at Week 24. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Pharmacokinetic Parameter Population.

Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance

An analysis of changes at specific amino acids in the IN coding region associated with resistance to raltegravir, elvitegravir, or DTG was performed at Day 1 and at the time of PDVF. PDVF is a <0.5 log10 copies(c)/mL decrease in plasma HIV-1 RNA at Day 8 unless the absolute value is <400 c/mL. PDVF after Day 8 is defined as virological non-respones (decrease in plasma HIV-1 RNA of <1 log10 c/mL by Week 16, with subsequent confirmation, unless plasma HIV-1 RNA <400 c/mL and confirmed plasma HIV-1 RNA levels >=400 c/mL on or after Week 24) and virological rebound (confirmed rebound in plasma HIV-1 RNA levels to >=400 c/mL after prior confirmed suppression to <400 c/mL and confirmed plasma HIV-1 RNA levels >1 log10 c/mL above the nadir value [nadir: >=400 c/mL]).

Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) Between Baseline and the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance

The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF. The number of participants with the indicated change (ratio) in the two values at the time of PDVF is presented. PDVF is defined as a <0.5 log10 copies/mL decrease in plasma HIV-1 RNA at Day 8 unless the absolute value is <400 copies/mL. PDVF after Day 8 was defined for virological non-response (decrease in plasma HIV-1 RNA of less than 1 log10 copies/mL by Week 16, with subsequent confirmation, unless plasma HIV-1 RNA <400 copies/mL and confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24) and virological rebound (confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL and confirmed plasma HIV-1 RNA levels >1 log10 copies/mL above the nadir value, where nadir is >=400 copies/mL).

Full Information

NCT ID

NCT01328041

First Posted

March 31, 2011

Last Updated

December 7, 2015

Sponsor

ViiV Healthcare

Collaborators

Shionogi, GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01328041

Brief Title

A Study to Assess Dolutegravir in HIV-infected Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen.

Acronym

VIKING-3

Official Title

A Phase III Study to Demonstrate the Antiviral Activity and Safety of Dolutegravir in HIV-1 Infected Adult Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ViiV Healthcare

Collaborators

Shionogi, GlaxoSmithKline

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this trial is to assess the antiviral activity and safety of a dolutegravir (DTG) containing regimen in HIV-1 infected, antiretroviral therapy (ART)-experienced adults with current or historical failure on an integrase inhibitor (INI) containing regimen. The study will assess DTG 50mg twice daily administered initially with the current failing ART regimen but then with an optimised background ART regimen (OBR) after Day 7. The first analyses will be conducted after the last subject enrolled has completed 24 weeks. Subjects may remain on study after Week 24.

Detailed Description

ING112574 is a Phase 3, multicentre, open-label, single arm study to assess the antiviral activity and safety of DTG containing regimen in HIV-1 infected ART-experienced adults with historical or current evidence of resistance to RAL or ELV. Initially, a minimum of 100 subjects will be enrolled to receive DTG 50mg twice daily with the current failing regimen for 7 days but with OBR from Day 8. Subjects must also have documented genotypic and/or phenotypic resistance to at least one compound in two or more of the other approved classes of ART but must also be able to include at least one fully active drug in the OBR to be started Day 8. The first data cut will take place after the (approximate) 100th subject enrolled completes the Week 24 visit. Enrollment will continue until a further 50 to 100 subjects have been recruited. All subjects who successfully complete 24 weeks of treatment will continue to have access to DTG until it is locally available as long as they continue to derive clinical benefit. ViiV Healthcare is the sponsor of this study.

6. Conditions and Keywords

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

Infection, Human Immunodeficiency Virus

Keywords

GSK1349572, resistance to raltegravir or elvitegravir, Integrase inhibitor, ART-experienced, dolutegravir

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

183 (Actual)

8. Arms, Groups, and Interventions

Arm Title

dolutegravir

Arm Type

Experimental

Arm Description

dolutegravir plus background antiretroviral therapy optimised at Day 8

Intervention Type

Drug

Intervention Name(s)

dolutegravir

Intervention Description

50 mg twice daily

Primary Outcome Measure Information:

Title

Mean Change From Baseline in Plasma HIV-1 RNA at Day 8

Description

Time Frame

Baseline and Day 8

Title

Number of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 24

Description

Time Frame

Week 24

Title

Number of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 48

Description

Time Frame

Week 48

Title

Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)

Description

Time Frame

From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)

Title

Number of Participants With Adverse Events of the Indicated Severity, Per the Division of Acquired Immune Deficiency Syndrome (DAIDS) Grading Scale

Description

Time Frame

From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)

Title

Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade

Description

Time Frame

From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)

Title

Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade

Description

Time Frame

From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)

Secondary Outcome Measure Information:

Title

Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48

Description

Time Frame

Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48

Title

Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion

Description

Time Frame

From Week 48 every 12 weeks up to study completion.

Title

Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study Completion

Description

Time Frame

Baseline; Day 8; Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study completion (Up to Week 180)

Title

Absolute Values for CD4+ Cell Counts at Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 and for CD8+ Cell Counts at Baseline and Weeks 4, 12, 24, and 48

Description

Absolute values for CD4+ cell counts were assessed at Baseline, Day 8 and Weeks 4, 8, 12, 16, and 24, and absolute values for CD8+ cell counts were assessed at Baseline and Weeks 4, 12, 24, and 48.

Time Frame

Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48

Title

Median Change From Baseline in CD4+ Cell Counts at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks Until Study Completion

Description

Time Frame

Baseline; Day 8; Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168 and 180. v

Title

Ratio of CD4+/CD8+ Cell Count at Baseline and Weeks 4, 12, 24, and 48

Description

The ratio of CD4+/CD8+ cell count (measured in cells/mm^3) was assessed at Baseline and at Weeks 4, 12, 24, and 48. The ratio was calculated as the CD4+ cell count divided by CD8+ cell count.

Time Frame

Baseline; Weeks 4, 12, 24, and 48

Title

Number of Participants With HIV-1 Disease Progression (Acquired Immune Deficiency Syndrome [AIDS] or Death)

Description

Time Frame

From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)

Title

Cmax and Ctau of DTG

Description

Time Frame

Day 8, Week 4, and Week 24

Title

AUC(0-tau) and AUC(0-24) of DTG

Description

Time Frame

Day 8, Week 4, and Week 24

Title

C0 Assessment of DTG

Description

Time Frame

Day 8, Week 4, and Week 24

Title

Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance

Description

Time Frame

From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)

Title

Description

Time Frame

From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Screening plasma HIV-1 RNA ≥500 copies/mL ART-experienced, INI-experienced, DTG naïve Experienced virological failure on raltegravir (RAL) or elvitegravir (ELV) regimen The subject's HIV-1 shows resistance to RAL or ELV at Screening or at prior time point of virological failure on RAL or ELV Documented resistance to at least one drug from each of three or more of all approved classes of ART Be able to receive at least one fully active drug as part of the OBR from Day 8 Women capable of becoming pregnant must use appropriate contraception during the study (as defined by the protocol) Willing and able to understand and provide signed and dated written informed consent prior to Screening. Exclusion Criteria: Women who are pregnant or breast feeding An active AIDS-defining condition at Screening (except cutaneous Kaposi's sarcoma not requiring systemic therapy or CD4+ <200c/mm3) Moderate to severe hepatic impairment as defined by Child-Pugh classification Anticipated need for HCV therapy during the first 24 weeks of the study Recent history of any upper or lower gastrointestinal bleed, with the exception of anal or rectal bleeding Allergy or intolerance to the study drugs or their components or drugs of their class Malignancy within the past 6 months Treatment with an HIV-1 therapeutic vaccine within 90 days of Screening Treatment with radiation therapy, cytotoxic chemotherapeutic agents or any immunomodulator within 28 days of Screening Treatment with any agent, other than licensed ART, with documented activity against HIV-1 in vitro within 28 days of first dose of investigational product Treatment with etravirine, efavirenz, or nevirapine within 14 days of Day 1(etravirine may be used if coadministered with lopinivir/ritonavir or darunavir/ritonavir) Treatment with tipranivir/ritonavir, fosamprenavir, or fosamprenavir/ritonavir within 28 days prior to Screening Verified Grade 4 laboratory abnormality at Screening ALT> 5 times the upper limit of normal (ULN) at Screening ALT ≥ 3X ULN and bilirubin > 1.5 X ULN (with 35% direct bilirubin) at Screening

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

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

GSK Investigational Site

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Facility Name

GSK Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

GSK Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90069

Country

United States

Facility Name

GSK Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92103-8208

Country

United States

Facility Name

GSK Investigational Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94109

Country

United States

Facility Name

GSK Investigational Site

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

GSK Investigational Site

City

Norwalk

State/Province

Connecticut

ZIP/Postal Code

06850

Country

United States

Facility Name

GSK Investigational Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

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

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33316

Country

United States

Facility Name

GSK Investigational Site

City

Fort Pierce

State/Province

Florida

ZIP/Postal Code

34982

Country

United States

Facility Name

GSK Investigational Site

City

Miami Beach

State/Province

Florida

ZIP/Postal Code

33139

Country

United States

Facility Name

GSK Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32804

Country

United States

Facility Name

GSK Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30308

Country

United States

Facility Name

GSK Investigational Site

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

Facility Name

GSK Investigational Site

City

Lafayette

State/Province

Louisiana

ZIP/Postal Code

70506

Country

United States

Facility Name

GSK Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

GSK Investigational Site

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39216-4505

Country

United States

Facility Name

GSK Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106

Country

United States

Facility Name

GSK Investigational Site

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07103

Country

United States

Facility Name

GSK Investigational Site

City

Albany

State/Province

New York

ZIP/Postal Code

12209

Country

United States

Facility Name

GSK Investigational Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

GSK Investigational Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Facility Name

GSK Investigational Site

City

Buffalo

State/Province

New York

ZIP/Postal Code

14215

Country

United States

Facility Name

GSK Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10011

Country

United States

Facility Name

GSK Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

GSK Investigational Site

City

Valhalla

State/Province

New York

ZIP/Postal Code

10595

Country

United States

Facility Name

GSK Investigational Site

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

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

Toledo

State/Province

Ohio

ZIP/Postal Code

43614

Country

United States

Facility Name

GSK Investigational Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

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

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

GSK Investigational Site

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02906

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

75204

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

Houston

State/Province

Texas

ZIP/Postal Code

77004

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77098

Country

United States

Facility Name

GSK Investigational Site

City

Annandale

State/Province

Virginia

ZIP/Postal Code

22003

Country

United States

Facility Name

GSK Investigational Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

GSK Investigational Site

City

Bruxelles

ZIP/Postal Code

1000

Country

Belgium

Facility Name

GSK Investigational Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

GSK Investigational Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6Z 1Y6

Country

Canada

Facility Name

GSK Investigational Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6Z 2C7

Country

Canada

Facility Name

GSK Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 3Z5

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4T 3A7

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5B 1L6

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 4P9

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 5B1

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2W 1T8

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 2P4

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3G 1A4

Country

Canada

Facility Name

GSK Investigational Site

City

Aulnay-sous-Bois

ZIP/Postal Code

93602

Country

France

Facility Name

GSK Investigational Site

City

Bobigny

ZIP/Postal Code

93009

Country

France

Facility Name

GSK Investigational Site

City

Bordeaux

ZIP/Postal Code

33000

Country

France

Facility Name

GSK Investigational Site

City

Garches

ZIP/Postal Code

92380

Country

France

Facility Name

GSK Investigational Site

City

Gonesse cedex

ZIP/Postal Code

95503

Country

France

Facility Name

GSK Investigational Site

City

Marseille

ZIP/Postal Code

13003

Country

France

Facility Name

GSK Investigational Site

City

Marseille

ZIP/Postal Code

13009

Country

France

Facility Name

GSK Investigational Site

City

Nice

ZIP/Postal Code

06202

Country

France

Facility Name

GSK Investigational Site

City

Orléans Cedex 2

ZIP/Postal Code

45067

Country

France

Facility Name

GSK Investigational Site

City

Paris Cedex 10

ZIP/Postal Code

75475

Country

France

Facility Name

GSK Investigational Site

City

Paris Cedex 13

ZIP/Postal Code

75651

Country

France

Facility Name

GSK Investigational Site

City

Paris cedex 14

ZIP/Postal Code

75679

Country

France

Facility Name

GSK Investigational Site

City

Paris cedex 15

ZIP/Postal Code

75743

Country

France

Facility Name

GSK Investigational Site

City

Paris Cedex 20

ZIP/Postal Code

75970

Country

France

Facility Name

GSK Investigational Site

City

Paris

ZIP/Postal Code

75018

Country

France

Facility Name

GSK Investigational Site

City

Genova

State/Province

Liguria

ZIP/Postal Code

16138

Country

Italy

Facility Name

GSK Investigational Site

City

Bergamo

State/Province

Lombardia

ZIP/Postal Code

24127

Country

Italy

Facility Name

GSK Investigational Site

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20127

Country

Italy

Facility Name

GSK Investigational Site

City

Torino

State/Province

Piemonte

ZIP/Postal Code

10149

Country

Italy

Facility Name

GSK Investigational Site

City

Bagno a Ripoli (FI)

State/Province

Toscana

ZIP/Postal Code

50011

Country

Italy

Facility Name

GSK Investigational Site

City

Firenze

State/Province

Toscana

ZIP/Postal Code

50134

Country

Italy

Facility Name

GSK Investigational Site

City

Amadora

Country

Portugal

Facility Name

GSK Investigational Site

City

Coimbra

ZIP/Postal Code

3030

Country

Portugal

Facility Name

GSK Investigational Site

City

Lisboa

ZIP/Postal Code

1150

Country

Portugal

Facility Name

GSK Investigational Site

City

Lisboa

ZIP/Postal Code

1349-019

Country

Portugal

Facility Name

GSK Investigational Site

City

Lisboa

ZIP/Postal Code

1649-035

Country

Portugal

Facility Name

GSK Investigational Site

City

Alicante

ZIP/Postal Code

03010

Country

Spain

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

La Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28029

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

GSK Investigational Site

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

23225901

Citation

Eron JJ, Clotet B, Durant J, Katlama C, Kumar P, Lazzarin A, Poizot-Martin I, Richmond G, Soriano V, Ait-Khaled M, Fujiwara T, Huang J, Min S, Vavro C, Yeo J; VIKING Study Group. Safety and efficacy of dolutegravir in treatment-experienced subjects with raltegravir-resistant HIV type 1 infection: 24-week results of the VIKING Study. J Infect Dis. 2013 Mar 1;207(5):740-8. doi: 10.1093/infdis/jis750. Epub 2012 Dec 7.

Results Reference

background

PubMed Identifier

24446523

Citation

Castagna A, Maggiolo F, Penco G, Wright D, Mills A, Grossberg R, Molina JM, Chas J, Durant J, Moreno S, Doroana M, Ait-Khaled M, Huang J, Min S, Song I, Vavro C, Nichols G, Yeo JM; VIKING-3 Study Group. Dolutegravir in antiretroviral-experienced patients with raltegravir- and/or elvitegravir-resistant HIV-1: 24-week results of the phase III VIKING-3 study. J Infect Dis. 2014 Aug 1;210(3):354-62. doi: 10.1093/infdis/jiu051. Epub 2014 Jan 19.

Results Reference

derived

Learn more about this trial

A Study to Assess Dolutegravir in HIV-infected Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen.

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A Study to Assess Dolutegravir in HIV-infected Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen. (VIKING-3)

Infection, Human Immunodeficiency Virus

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

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