Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborators:
Shionogi
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01328041
First received: March 31, 2011
Last updated: December 7, 2015
Last verified: December 2015
Results First Received: August 15, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Infection, Human Immunodeficiency Virus
Intervention: Drug: dolutegravir

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants (par.) having documented Human immunodeficiency virus type 1 (HIV-1) infection with a plasma HIV-1 Ribonucleic acid(RNA) >=500 copies per milliliter (c/mL) at Screening, Antiretroviral therapy (ART)-experienced and on stable ART for at least one month prior to Screening were enrolled

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 139 par. were screen failures and 183 par. entered the single arm, open-label study.

Reporting Groups
  Description
Dolutegravir 50 mg BID Participants received dolutegravir (DTG) 50 milligrams (mg) twice a day (BID).

Participant Flow:   Overall Study
    Dolutegravir 50 mg BID
STARTED   183 
COMPLETED   126 
NOT COMPLETED   57 
Adverse Event                7 
Lack of Efficacy                27 
Protocol Violation                7 
Lost to Follow-up                7 
Physician Decision                2 
Withdrawal by Subject                7 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Dolutegravir 50 mg BID Participants received DTG 50 mg BID.

Baseline Measures
   Dolutegravir 50 mg BID 
Overall Participants Analyzed 
[Units: Participants]
 183 
Age 
[Units: Years]
Median (Full Range)
 48 
 (19 to 67) 
Gender 
[Units: Participants]
 
Female   42 
Male   141 
Race/Ethnicity, Customized 
[Units: Participants]
 
African American/African Heritage   49 
American Indian or Alaska Native and White   1 
Asian-Central/South Asian Heritage   1 
White   130 
White and African American/African Heritage   2 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change From Baseline in Plasma HIV-1 RNA at Day 8   [ Time Frame: Baseline and Day 8 ]

2.  Primary:   Number of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 24   [ Time Frame: Week 24 ]

3.  Primary:   Number of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 48   [ Time Frame: Week 48 ]

4.  Primary:   Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)   [ 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) ]

5.  Primary:   Number of Participants With Adverse Events of the Indicated Severity, Per the Division of Acquired Immune Deficiency Syndrome (DAIDS) Grading Scale   [ 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) ]

6.  Primary:   Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade   [ 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) ]

7.  Primary:   Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade   [ 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) ]

8.  Secondary:   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   [ Time Frame: Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 ]

9.  Secondary:   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   [ Time Frame: From Week 48 every 12 weeks up to study completion. ]

10.  Secondary:   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   [ 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) ]

11.  Secondary:   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   [ Time Frame: Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 ]

12.  Secondary:   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   [ 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 ]

13.  Secondary:   Ratio of CD4+/CD8+ Cell Count at Baseline and Weeks 4, 12, 24, and 48   [ Time Frame: Baseline; Weeks 4, 12, 24, and 48 ]

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

15.  Secondary:   Cmax and Ctau of DTG   [ Time Frame: Day 8, Week 4, and Week 24 ]

16.  Secondary:   AUC(0-tau) and AUC(0-24) of DTG   [ Time Frame: Day 8, Week 4, and Week 24 ]

17.  Secondary:   C0 Assessment of DTG   [ Time Frame: Day 8, Week 4, and Week 24 ]

18.  Secondary:   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   [ 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) ]

19.  Secondary:   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   [ 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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: ViiV Healthcare
phone: 866-435-7343


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01328041     History of Changes
Other Study ID Numbers: 112574
Study First Received: March 31, 2011
Results First Received: August 15, 2013
Last Updated: December 7, 2015
Health Authority: Italy: AIFA - Italian Ministry of Health
Spain: Agencia Española del Medicamento y Productos Sanitarios
Portugal: Infarmed - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.
Belgium: Agence Fédérale des Medicaments et des Produits de la Santé
United States: Food and Drug Administration
Canada: Health Canada
France: Agence Française de Sécurité Sanitaire des Produits de Santé