A Phase IIIb Study of the Safety, Efficacy, and Tolerability of Switching to a Fixed-dose Combination of Abacavir/Dolutegravir/ Lamivudine From Current Antiretroviral Regimen

This study has been completed.
Sponsor:
Collaborators:
PPD
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT02105987
First received: April 3, 2014
Last updated: January 28, 2016
Last verified: January 2016
Results First Received: December 10, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Infection, Human Immunodeficiency Virus
Interventions: Drug: ABC/DTG/3TC FDC
Drug: Ongoing cART regimen

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
841 participants (par.) were screened and 555 human immunodeficiency virus type 1 (HIV-1) infected par. who were on stable suppressive combination antiretroviral therapy (cART) with 2 nucleoside reverse transcriptase inhibitor (NRTIs) plus either a protease inhibitor (PI), an non-NRTI (NNRTI), or an integrase inhibitor (INI) were randomized.

Reporting Groups
  Description
ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Participants received abacavir (ABC) 600 milligrams (mg)/ dolutegravir (DTG) 50 mg/ lamivudine (3TC) 300 mg fixed-dose combination (FDC) tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
Current ART Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.

Participant Flow:   Overall Study
    ABC 600 mg / DTG 50 mg /3TC 300 mg FDC     Current ART  
STARTED     274 [1]   277 [1]
Ongoing     0     1  
COMPLETED     239     244  
NOT COMPLETED     35     33  
Ongoing                 0                 1  
Adverse Event                 10                 0  
Protocol Violation                 15                 17  
Withdrawal by Subject                 4                 9  
Lost to Follow-up                 3                 3  
Physician Decision                 3                 3  
[1] Number Started represents the number of par. in the Intent-To-Treat Exposed (ITT-E) Population.



  Baseline Characteristics
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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
ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
Current ART Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
Total Total of all reporting groups

Baseline Measures
    ABC 600 mg / DTG 50 mg /3TC 300 mg FDC     Current ART     Total  
Number of Participants  
[units: participants]
  274     277     551  
Age  
[units: Years]
Mean (Standard Deviation)
  44.1  (10.62)     45.7  (11.21)     44.9  (10.94)  
Gender  
[units: Participants]
     
Female     38     40     78  
Male     236     237     473  
Race/Ethnicity, Customized  
[units: Participants]
     
African American/African Heritage     81     76     157  
American Indian or Alaska Native     2     2     4  
Asian - Central/South Asian Heritage     1     2     3  
Asian - East Asian Heritage     1     3     4  
Asian - Japanese Heritage     1     1     2  
Asian - South East Asian Heritage     1     2     3  
Asian - Mixed Race     1     0     1  
Native Hawaiian or other Pacific Islander     1     1     2  
White - Arabic/North African Heritage     2     1     3  
White - White/Caucasian/European Heritage     174     182     356  
White - Mixed Race     3     3     6  
Mixed Race     1     1     2  
Missing     5     3     8  



  Outcome Measures
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1.  Primary:   Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies Per Milliliter (c/mL) at Week 24 Using the Snapshot Algorithm   [ Time Frame: Week 24 ]

2.  Secondary:   Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 24   [ Time Frame: Baseline and Week 24 ]

3.  Secondary:   Number of Participants in the Virologic Non-response Category From the Snapshot Analysis at Week 24   [ Time Frame: Week 24 ]

4.  Secondary:   Number of Participants With Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) up to 24 Weeks   [ Time Frame: Baseline and up to 24 weeks ]

5.  Secondary:   Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to 24 Weeks   [ Time Frame: Baseline and up to 24 weeks ]

6.  Secondary:   Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to 24 Weeks   [ Time Frame: Baseline and up to 24 weeks ]

7.  Secondary:   Number of Participants With AEs Leading to Withdrawal Over 24 Weeks   [ Time Frame: Baseline and up to 24 weeks ]

8.  Secondary:   Change From Baseline in Fasting Lipids (Cholesterol, LDL Cholesterol, HDL Cholesterol, and Triglycerides) at Week 24   [ Time Frame: Baseline and Week 24 ]

9.  Secondary:   Change From Baseline in Fasting Lipids (Total Cholesterol/HDL Cholesterol Ratio) at Week 24   [ Time Frame: Baseline and Week 24 ]

10.  Secondary:   Change From Baseline in Treatment Satisfaction at Week 4 and Week 24   [ Time Frame: Baseline, Week 4 and Week 24 ]

11.  Secondary:   Change From Baseline in Creatinine at Week 24   [ Time Frame: Baseline and Week 24 ]

12.  Secondary:   Change From Baseline in Glomerular Filtration Rate (GFR) From Creatinine Adjusted Using CKD-EPI Equation at Week 24   [ Time Frame: Baseline and Week 24 ]

13.  Secondary:   Change From Baseline in GFR From Creatinine Adjusted Using MDRD Enzymatic Equation at Week 24   [ Time Frame: Baseline and Week 24 ]

14.  Secondary:   Change From Baseline in Urea at Week 24   [ Time Frame: Baseline and Week 24 ]

15.  Secondary:   Change From Baseline in Urine Albumin/Creatinine Ratio at Week 24   [ Time Frame: Baseline and Week 24 ]

16.  Secondary:   Change From Baseline in Bone Marker Analytes at Week 24   [ Time Frame: Baseline and Week 24 ]

17.  Secondary:   Change From Baseline in Cardiovascular Marker Analytes at Week 24   [ Time Frame: Baseline and Week 24 ]

18.  Secondary:   Change From Baseline in Cardiovascular Marker Analyte, C-reactive Protein at Week 24   [ Time Frame: Baseline and Week 24 ]

19.  Secondary:   Change From Baseline in Cardiovascular Marker Analyte, D-Dimer at Week 24   [ Time Frame: Baseline and Week 24 ]

20.  Secondary:   Change From Baseline in Cardiovascular Marker Analyte, Homostat Model Assess of Insulin Resistance at Week 24   [ Time Frame: Baseline and Week 24 ]

21.  Secondary:   Change From Baseline in Cardiovascular Marker Analyte, Insulin at Week 24   [ Time Frame: Baseline and Week 24 ]

22.  Secondary:   Change From Baseline in Cardiovascular Marker Analyte, Soluble CD163 at Week 24   [ Time Frame: Baseline and Week 24 ]

23.  Secondary:   Change From Baseline in Cardiovascular Marker Analyte, Glucose at Week 24   [ Time Frame: Baseline and Week 24 ]

24.  Secondary:   Number of Participants With Incidence of Genotypic and Phenotypic Resistance Meeting Virologic Withdrawal Criteria Over 24 Weeks   [ Time Frame: Baseline and up to 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: GlaxoSmithKline
phone: 866-435-7343



Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT02105987     History of Changes
Obsolete Identifiers: NCT02131025
Other Study ID Numbers: 201147
Study First Received: April 3, 2014
Results First Received: December 10, 2015
Last Updated: January 28, 2016
Health Authority: United States: Food and Drug Administration