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A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01910402
First received: July 25, 2013
Last updated: September 13, 2016
Last verified: July 2016
Results First Received: July 25, 2016  
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: Dolutegravir/abacavir/lamivudine FDC
Drug: Atazanavir
Drug: Ritonavir
Drug: Tenofovir/emtricitabine FDC

  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
The study consists of a Screening (14-28 days), Randomized (48 weeks) and Continuation (Cont.) Phase. Participants were said to have completed the study if they completed the Randomized phase and did not enter the Cont. Phase. Participants entering the Cont. Phase were said to have completed the study if they completed both phases of the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 499 participants were randomized to receive dolutegravir (DTG)/ abacavir (ABC)/ lamivudine (3TC) fixed dose combination (FDC) or combination of atazanavir (ATV), Ritonavir (RTV) and FDC of tenofovir disoproxil fumarate/emtricitabine (TDF/FTC). A total of 495 participants received at least single dose of investigational products (IP).

Reporting Groups
  Description
DTG 50 mg/ABC 600 mg/3TC 300 mg QD Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.

Participant Flow for 2 periods

Period 1:   Randomized Phase
    DTG 50 mg/ABC 600 mg/3TC 300 mg QD   ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
STARTED   248   247 
COMPLETED   206   192 
NOT COMPLETED   42   55 
Adverse Event                10                18 
Physician Decision                1                0 
Lack of Efficacy                5                4 
Lost to Follow-up                11                13 
Protocol Violation                10                13 
Withdrawal by Subject                5                7 

Period 2:   Continuation Phase
    DTG 50 mg/ABC 600 mg/3TC 300 mg QD   ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
STARTED   120   0 
COMPLETED   30   0 
NOT COMPLETED   90   0 
Ongoing                84                0 
Adverse Event                1                0 
Protocol Violation                3                0 
Withdrawal by Subject                2                0 



  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
DTG 50 mg/ABC 600 mg/3TC 300 mg QD Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
Total Total of all reporting groups

Baseline Measures
   DTG 50 mg/ABC 600 mg/3TC 300 mg QD   ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD   Total 
Overall Participants Analyzed 
[Units: Participants]
 248   247   495 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.1  (11.15)   37.8  (10.14)   37.9  (10.65) 
Gender 
[Units: Participants]
     
Female   248   247   495 
Male   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
     
African American/African Heritage   102   108   210 
American Indian Or Alaskan Native   6   7   13 
Asian - Central/South Asian Heritage   2   0   2 
Asian - East Asian Heritage   0   1   1 
Asian - South East Asian Heritage   20   22   42 
Native Hawaiian Or Other Pacific Islander   1   0   1 
White - Arabic/North African Heritage   3   3   6 
White - White/Caucasian/European Heritage   112   104   216 
Mixed Race   2   2   4 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48   [ Time Frame: Week 48 ]

2.  Secondary:   Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time   [ Time Frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48 ]

3.  Secondary:   Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points   [ Time Frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48 ]

4.  Secondary:   Change From Baseline in CD4+ Cell Count at Indicated Timepoints   [ Time Frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48 ]

5.  Secondary:   Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points   [ Time Frame: Baseline, Week 4, 12, 24, 36, 48 ]

6.  Secondary:   Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints.   [ Time Frame: Baseline, Week 4, 12, 24, 36, 48 ]

7.  Secondary:   Change From Baseline in Albumin at Indicated Timepoints.   [ Time Frame: Baseline, Week 4, 12, 24, 36, 48 ]

8.  Secondary:   Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points   [ Time Frame: Baseline, Week 4, 12, 24, 36, 48 ]

9.  Secondary:   Change From Baseline in Creatinine Clearance at Indicated Time Points   [ Time Frame: Baseline, Week 4, 12, 24, 36, 48 ]

10.  Secondary:   Change From Baseline in Lipase at Indicated Timepoints.   [ Time Frame: Baseline, Week 4, 12, 24, 36, 48 ]

11.  Secondary:   Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints.   [ Time Frame: Baseline, Week 4, 12, 24, 36, 48 ]

12.  Secondary:   Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points   [ Time Frame: Baseline, Week 4, 12, 24, 36, 48 ]

13.  Secondary:   Change From Baseline in Erythrocytes at Indicated Time Points.   [ Time Frame: Baseline, Week 4, 12, 24, 36, 48 ]

14.  Secondary:   Change From Baseline in Hematocrit Count at Indicated Time Points.   [ Time Frame: Baseline, Week 4, 12, 24, 36, 48 ]

15.  Secondary:   Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points.   [ Time Frame: Baseline, Week 4, 12, 24, 36, 48 ]

16.  Secondary:   Change From Baseline in Triglycerides at Week 48   [ Time Frame: Baseline and Week 48 ]

17.  Secondary:   Change From Baseline in TC/HDL Ratio at Week 48   [ Time Frame: Baseline and Week 48 ]

18.  Secondary:   Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points   [ Time Frame: Baseline, Week 24, Week 48 ]

19.  Secondary:   Summary of AEs by Maximum Toxicity as Per DAIDS AE Grading Table.   [ Time Frame: Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC ]

20.  Secondary:   Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs)   [ Time Frame: From start of IP through the Study Phase (Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC) ]

21.  Secondary:   Summary of Maximum Post-Baseline Emergent Chemistry Toxicities   [ Time Frame: Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC ]

22.  Secondary:   Summary of Maximum Post-Baseline Emergent Hematology Toxicities   [ Time Frame: Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC ]

23.  Secondary:   Number of Participants Who Withdrew From Treatment Due to AEs   [ Time Frame: average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC ]

24.  Secondary:   Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints   [ Time Frame: Baseline, Week 24, 48 ]

25.  Secondary:   Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints   [ Time Frame: Baseline, Week 24, 48 ]

26.  Secondary:   Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48   [ Time Frame: Baseline, Weeks 24, 48 ]

27.  Secondary:   Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline   [ Time Frame: Baseline, Weeks 24, 48 ]

28.  Secondary:   Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS   [ Time Frame: Baseline and Week 48 ]

29.  Secondary:   Assessment of HIVTSQs Total Score at Indicated Timepoints.   [ Time Frame: Week 4, 12, 24, 48 ]

30.  Secondary:   Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups   [ Time Frame: Week 48 ]

31.  Secondary:   Number of Participants With Post-Baseline HIV-1 Disease Progression   [ Time Frame: Up to week 48 ]

32.  Secondary:   Number of Participants With Treatment Emergent Resistances   [ Time Frame: Up to week 48 ]


  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: NCT01910402     History of Changes
Other Study ID Numbers: 117172
Study First Received: July 25, 2013
Results First Received: July 25, 2016
Last Updated: September 13, 2016
Health Authority: Mexico: Ministry of Health
Portugal: The National Institue of Pharmacy and Medicines (Infarmed)
Italy: Italian Medicines Agency
Argentina: Ministry of Health - A.N.M.A.T
South Africa: Medicines Control Council
Thailand: Food and Drug Administration
United States: Food and Drug Administration
Russia: Russian Ministry of Health
France: National Agency for the Safety of Medicine and Health Products
Spain: Spanish Agency for Medicines and Health Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada