Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dolutegravir Plus Lamivudine Dual Therapy in Treatment Naïve HIV-1 Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02582684
Recruitment Status : Completed
First Posted : October 21, 2015
Results First Posted : March 30, 2018
Last Update Posted : May 9, 2018
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV-1 Infection
Interventions Drug: Dolutegravir
Drug: Lamivudine
Enrollment 122
Recruitment Details  
Pre-assignment Details A total of 122 participants were accrued.
Arm/Group Title Arm 1: DTG 50 MG + 3TC 300 mg
Hide Arm/Group Description

Dolutegravir: Participants were prescribed 50 mg of DTG orally daily

Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.

Period Title: Overall Study
Started 122
Completed 105
Not Completed 17
Reason Not Completed
Unable to contact subject/parent             4
Subject not able to get to clinic             10
Subject withdrew consent             1
Found to be ineligible after enrollment             2
Arm/Group Title Arm 1: DTG 50 MG + 3TC 300 mg
Hide Arm/Group Description

Dolutegravir: Participants were prescribed 50 mg of DTG orally daily

Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.

Overall Number of Baseline Participants 120
Hide Baseline Analysis Population Description
All eligible participants enrolled.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Age Number Analyzed 120 participants
30
(24 to 41)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age Category Number Analyzed 120 participants
18-29 years
58
  48.3%
30-39 years
29
  24.2%
40-49 years
17
  14.2%
50-59 years
12
  10.0%
>= 60 years
4
   3.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants
Female
16
  13.3%
Male
104
  86.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 120 participants
White Non-Hispanic
34
  28.3%
Black Non-Hispanic
48
  40.0%
Hispanic (Regardless of Race)
32
  26.7%
Asian, Pacific Islander
2
   1.7%
More than one race
2
   1.7%
Does not want to report
2
   1.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Puerto Rico Number Analyzed 120 participants
3
   2.5%
United States Number Analyzed 120 participants
117
  97.5%
Intravenous Drug Use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants
Never
113
  94.2%
Currently
2
   1.7%
Previously
5
   4.2%
CD4 Count, Continuous   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Cells/mm^3
Number Analyzed 118 participants
387
(288 to 596)
[1]
Measure Analysis Population Description: 2 participants with missing baseline CD4 counts.
CD4 Count, Categorized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants
<200 cells/mm^3
16
  13.3%
200-349 cells/mm^3
27
  22.5%
350-499 cells/mm^3
30
  25.0%
500-649 cells/mm^3
19
  15.8%
650-799 cells/mm^3
15
  12.5%
>=800 cells/mm^3
11
   9.2%
Missing
2
   1.7%
CD8 Count   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Cells/mm^3
Number Analyzed 107 participants
871
(610 to 1167)
[1]
Measure Analysis Population Description: Total of 13 participants missing CD8 Count at baseline.
CD4/CD8 Ratio   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Ratio
Number Analyzed 107 participants
0.44
(0.31 to 0.70)
[1]
Measure Analysis Population Description: Total of 13 participants had missing measurements that contribute to the CD4/CD8 ratio.
Screening HIV-1 RNA  
Median (Inter-Quartile Range)
Unit of measure:  Log10 copies/mL
Number Analyzed 120 participants
4.70
(4.08 to 5.00)
Baseline HIV-1 RNA   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Log10 copies/mL
Number Analyzed 120 participants
4.61
(3.94 to 5.05)
[1]
Measure Description: Baseline HIV-1 RNA is defined as the last nonmissing observation on or prior to first dose date after screening.
Baseline HIV-1 RNA Category   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants
< 1,000 copies/mL
1
   0.8%
1,000 - 9,999 copies/mL
34
  28.3%
10,000 - 99,999 copies/mL
48
  40.0%
100,000 - 200,000 copies/mL
23
  19.2%
> 200,000 copies/mL
14
  11.7%
[1]
Measure Description: Baseline HIV-1 RNA is defined as the last nonmissing observation on or prior to first dose date after screening.
Hepatitis C Antibody Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants
Positive
4
   3.3%
Negative
116
  96.7%
Post-exposure Prophylaxis or Pre-Exposure Prophylaxis History  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants
Yes
1
   0.8%
No
119
  99.2%
1.Primary Outcome
Title Virologic Status at Week 24
Hide Description

Numbers of Participants With Virologic Success, Virologic Non-Success, and no Virologic Data at Week 24 Window are provided below.

Virologic success is defined as HIV-1 RNA <50 copies/mL and on study treatment (FDA Snapshot definition).

Time Frame At 24 weeks after study entry
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible participants enrolled.
Arm/Group Title Arm 1: DTG 50 MG + 3TC 300 mg
Hide Arm/Group Description:

Dolutegravir: Participants were prescribed 50 mg of DTG orally daily

Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.

Overall Number of Participants Analyzed 120
Measure Type: Count of Participants
Unit of Measure: Participants
Virologic success
108
  90.0%
Virologic non-success
5
   4.2%
No virologic data in window
7
   5.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: DTG 50 MG + 3TC 300 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Binomial Proportion of Participants with Virologic Success and 95% Confidence Interval
Method of Estimation Estimation Parameter proportion
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.83 to 0.95
Estimation Comments Confidence interval was calculated using the Clopper-Pearson exact method.
2.Secondary Outcome
Title Virologic Status at Week 12
Hide Description

Numbers of Participants With Virologic Success, Virologic Non-Success, and no Virologic Data at Week 12 Window are provided below.

Virologic success is defined as HIV-1 RNA <50 copies/mL and on study treatment (FDA Snapshot definition).

Time Frame At 12 weeks after study entry
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible participants enrolled.
Arm/Group Title Arm 1: DTG 50 MG + 3TC 300 mg
Hide Arm/Group Description:

Dolutegravir: Participants were prescribed 50 mg of DTG orally daily

Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.

Overall Number of Participants Analyzed 120
Measure Type: Count of Participants
Unit of Measure: Participants
Virologic success
107
  89.2%
Virologic non-success
7
   5.8%
No virologic data in window
6
   5.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: DTG 50 MG + 3TC 300 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Binomial Proportion of Participants with Virologic Success and 95% Confidence Interval
Method of Estimation Estimation Parameter Proportion
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.82 to 0.94
Estimation Comments Confidence interval was calculated using the Clopper-Pearson exact method.
3.Secondary Outcome
Title Virologic Status at Week 48
Hide Description

Numbers of Participants With Virologic Success, Virologic Non-Success, and no Virologic Data at Week 48 Window are provided below.

Virologic success is defined as HIV-1 RNA <50 copies/mL and on study treatment (FDA Snapshot definition).

Time Frame At 48 weeks after study entry
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible participants enrolled.
Arm/Group Title Arm 1: DTG 50 MG + 3TC 300 mg
Hide Arm/Group Description:

Dolutegravir: Participants were prescribed 50 mg of DTG orally daily

Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.

Overall Number of Participants Analyzed 120
Measure Type: Count of Participants
Unit of Measure: Participants
Virologic success
102
  85.0%
Virologic non-success
6
   5.0%
No virologic data in window
12
  10.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: DTG 50 MG + 3TC 300 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments Binomial Proportion of Participants with Virologic Success and 95% Confidence Interval
Method of Estimation Estimation Parameter proportion
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.77 to 0.91
Estimation Comments Confidence interval was calculated using the Clopper-Pearson exact method.
4.Secondary Outcome
Title Virologic Failure
Hide Description

Virologic failure is defined as follows:

  • Weeks 16 or 20: confirmed plasma HIV-1 RNA > 400 copies/mL
  • Week 24 or later: confirmed plasma HIV-1 RNA > 200 copies/mL

    1. Participants were evaluated for virologic failure regardless of whether on study treatment.
    2. Confirmation was determined based on any two consecutive evaluations meeting the virologic failure definition regardless of the time between them.
    3. Participants discontinuing the study (for any reason, including death and lost to follow-up) were considered virologic failures if their last measurement met the definition of virologic failure but no confirmatory measurement was obtained. All other participants’ follow-up was censored immediately after the last available plasma HIV-1 RNA measurement.
Time Frame Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible participants enrolled.
Arm/Group Title Arm 1: DTG 50 MG + 3TC 300 mg
Hide Arm/Group Description:

Dolutegravir: Participants were prescribed 50 mg of DTG orally daily

Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.

Overall Number of Participants Analyzed 120
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
4
   3.3%
No
116
  96.7%
5.Secondary Outcome
Title Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/mL - Missing = Failure
Hide Description Proportion of participants with HIV-1 RNA < 50 copies/mL by week, ITT (Intention To Treat; missing/off study/off treatment = failure) population.
Time Frame Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
The population here is the ITT (missing/off study/off treatment = failure) population. The numerator includes participants with HIV-1 RNA < 50 copies/mL and still on initial treatment; the denominator includes all participants with potential for the given week of follow-up based on the date of registration.
Arm/Group Title Arm 1: DTG 50 MG + 3TC 300 mg
Hide Arm/Group Description:

Dolutegravir: Participants were prescribed 50 mg of DTG orally daily

Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.

Overall Number of Participants Analyzed 120
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
Week 2
0.40
(0.31 to 0.49)
Week 4
0.68
(0.58 to 0.76)
Week 8
0.85
(0.77 to 0.91)
Week 12
0.89
(0.82 to 0.94)
Week 16
0.88
(0.80 to 0.93)
Week 20
0.90
(0.83 to 0.95)
Week 24
0.90
(0.83 to 0.95)
Week 32
0.88
(0.80 to 0.93)
Week 40
0.89
(0.82 to 0.94)
Week 48
0.84
(0.76 to 0.90)
6.Secondary Outcome
Title Proportion of Participants With Plasma HIV-1 RNA < 200 Copies/mL - Missing = Failure
Hide Description Proportion of participants with HIV-1 RNA < 200 copies/mL by week, ITT (missing/off study/off treatment = failure) population.
Time Frame Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
The population here is the ITT (missing/off study/off treatment = failure) population. The numerator includes participants with HIV-1 RNA < 200 copies/mL and still on initial treatment; the denominator includes all participants with potential for the given week of follow-up based on the date of registration.
Arm/Group Title Arm 1: DTG 50 MG + 3TC 300 mg
Hide Arm/Group Description:

Dolutegravir: Participants were prescribed 50 mg of DTG orally daily

Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.

Overall Number of Participants Analyzed 120
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
Week 2
0.68
(0.59 to 0.77)
Week 4
0.90
(0.83 to 0.95)
Week 8
0.95
(0.89 to 0.98)
Week 12
0.93
(0.87 to 0.97)
Week 16
0.92
(0.85 to 0.96)
Week 20
0.95
(0.89 to 0.98)
Week 24
0.92
(0.85 to 0.96)
Week 32
0.89
(0.82 to 0.94)
Week 40
0.91
(0.84 to 0.95)
Week 48
0.87
(0.79 to 0.92)
7.Secondary Outcome
Title Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL - Missing = Ignored
Hide Description Proportion of participants with HIV-1 RNA < 50 copies/mL by week, ITT (missing = ignored) population.
Time Frame Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Missing = Ignored. The numerator includes participants with HIV-1 RNA < 50 copies/mL; the denominator includes all participants with an HIV-1 RNA evaluation at the given week.
Arm/Group Title Arm 1: DTG 50 MG + 3TC 300 mg
Hide Arm/Group Description:

Dolutegravir: Participants were prescribed 50 mg of DTG orally daily

Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.

Overall Number of Participants Analyzed 120
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
Week 2 Number Analyzed 116 participants
0.41
(0.32 to 0.51)
Week 4 Number Analyzed 115 participants
0.70
(0.61 to 0.79)
Week 8 Number Analyzed 116 participants
0.88
(0.81 to 0.93)
Week 12 Number Analyzed 114 participants
0.94
(0.88 to 0.97)
Week 16 Number Analyzed 112 participants
0.94
(0.88 to 0.97)
Week 20 Number Analyzed 115 participants
0.94
(0.88 to 0.98)
Week 24 Number Analyzed 114 participants
0.96
(0.90 to 0.99)
Week 32 Number Analyzed 113 participants
0.93
(0.87 to 0.97)
Week 40 Number Analyzed 114 participants
0.95
(0.89 to 0.98)
Week 48 Number Analyzed 109 participants
0.94
(0.87 to 0.97)
8.Secondary Outcome
Title Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- ITT Missing = Ignored
Hide Description Proportion of participants with HIV-1 RNA < 200 copies/mL by week, ITT (missing = ignored) population.
Time Frame Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Missing = Ignored. The numerator includes participants with HIV-1 RNA < 200 copies/mL; the denominator includes all participants with an HIV-1 RNA evaluation at the given week.
Arm/Group Title Arm 1: DTG 50 MG + 3TC 300 mg
Hide Arm/Group Description:

Dolutegravir: Participants were prescribed 50 mg of DTG orally daily

Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.

Overall Number of Participants Analyzed 120
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
Week 2 Number Analyzed 116 participants
0.71
(0.62 to 0.79)
Week 4 Number Analyzed 115 participants
0.94
(0.88 to 0.98)
Week 8 Number Analyzed 116 participants
0.98
(0.94 to 1.00)
Week 12 Number Analyzed 114 participants
0.98
(0.94 to 1.00)
Week 16 Number Analyzed 112 participants
0.98
(0.94 to 1.00)
Week 20 Number Analyzed 115 participants
0.99
(0.95 to 1.00)
Week 24 Number Analyzed 114 participants
0.97
(0.93 to 0.99)
Week 32 Number Analyzed 113 participants
0.95
(0.89 to 0.98)
Week 40 Number Analyzed 114 participants
0.96
(0.91 to 0.99)
Week 48 Number Analyzed 109 participants
0.96
(0.91 to 0.99)
9.Secondary Outcome
Title Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL- As Treated
Hide Description Proportion of participants with HIV-1 RNA < 50 copies/mL by week, as treated population.
Time Frame Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
As Treated: purely virologic missing = ignored. The numerator includes participants with HIV-1 RNA < 50 copies/mL and still on initial treatment; the denominator includes participants on initial treatment with an HIV-1 RNA evaluation at the given week.
Arm/Group Title Arm 1: DTG 50 MG + 3TC 300 mg
Hide Arm/Group Description:

Dolutegravir: Participants were prescribed 50 mg of DTG orally daily

Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.

Overall Number of Participants Analyzed 120
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
Week 2 Number Analyzed 116 participants
0.41
(0.32 to 0.51)
Week 4 Number Analyzed 115 participants
0.70
(0.61 to 0.79)
Week 8 Number Analyzed 116 participants
0.88
(0.81 to 0.93)
Week 12 Number Analyzed 114 participants
0.94
(0.88 to 0.97)
Week 16 Number Analyzed 112 participants
0.94
(0.88 to 0.97)
Week 20 Number Analyzed 115 participants
0.94
(0.88 to 0.98)
Week 24 Number Analyzed 112 participants
0.96
(0.91 to 0.99)
Week 32 Number Analyzed 110 participants
0.95
(0.90 to 0.99)
Week 40 Number Analyzed 110 participants
0.97
(0.92 to 0.99)
Week 48 Number Analyzed 104 participants
0.97
(0.92 to 0.99)
10.Secondary Outcome
Title Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- As Treated
Hide Description Proportion of participants with HIV-1 RNA < 200 copies/mL by week, as treated population.
Time Frame Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
As Treated: purely virologic missing=ignored. The numerator includes participants with HIV-1 RNA < 200 copies/mL and still on initial treatment; the denominator includes participants on initial treatment with an HIV-1 RNA evaluation at the given week.
Arm/Group Title Arm 1: DTG 50 MG + 3TC 300 mg
Hide Arm/Group Description:

Dolutegravir: Participants were prescribed 50 mg of DTG orally daily

Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.

Overall Number of Participants Analyzed 120
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
Week 2 Number Analyzed 116 participants
0.71
(0.62 to 0.79)
Week 4 Number Analyzed 115 participants
0.94
(0.88 to 0.98)
Week 8 Number Analyzed 116 participants
0.98
(0.94 to 1.00)
Week 12 Number Analyzed 114 participants
0.98
(0.94 to 1.00)
Week 16 Number Analyzed 112 participants
0.98
(0.94 to 1.00)
Week 20 Number Analyzed 115 participants
0.99
(0.95 to 1.00)
Week 24 Number Analyzed 112 participants
0.98
(0.94 to 1.00)
Week 32 Number Analyzed 110 participants
0.97
(0.92 to 0.99)
Week 40 Number Analyzed 110 participants
0.99
(0.95 to 1.00)
Week 48 Number Analyzed 104 participants
1.00
(0.97 to 1.00)
11.Secondary Outcome
Title CD4+ Cell Count
Hide Description CD4+ cell counts by study week.
Time Frame Baseline, weeks 4, 12, 24, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible participants enrolled with CD4 count results available at a given visit.
Arm/Group Title Arm 1: DTG 50 MG + 3TC 300 mg
Hide Arm/Group Description:

Dolutegravir: Participants were prescribed 50 mg of DTG orally daily

Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.

Overall Number of Participants Analyzed 120
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
Week 0 Number Analyzed 118 participants
387
(288 to 596)
Week 4 Number Analyzed 118 participants
473
(358 to 727)
Week 12 Number Analyzed 115 participants
520
(395 to 783)
Week 24 Number Analyzed 115 participants
582
(416 to 871)
Week 48 Number Analyzed 107 participants
579
(451 to 830)
12.Secondary Outcome
Title Change in CD4+ Cell Count
Hide Description Change in CD4+ cell counts by study week. Change was calculated as value at the later visit minus the value at baseline.
Time Frame Baseline, weeks 4, 12, 24, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible participants enrolled with CD4 cell count results available at baseline and the given visit.
Arm/Group Title Arm 1: DTG 50 MG + 3TC 300 mg
Hide Arm/Group Description:

Dolutegravir: Participants were prescribed 50 mg of DTG orally daily

Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.

Overall Number of Participants Analyzed 120
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
Change from Baseline to Week 4 Number Analyzed 116 participants
78
(10 to 154)
Change from Baseline to Week 12 Number Analyzed 113 participants
122
(67 to 185)
Change from Baseline to Week 24 Number Analyzed 113 participants
167
(86 to 275)
Change from Baseline to Week 48 Number Analyzed 105 participants
182
(104 to 284)
13.Secondary Outcome
Title Number of HIV-1 Drug Resistance Mutation Occurrences in Participants
Hide Description Number of HIV-1 drug resistance mutation occurrences participants with virologic failure and FDA snapshot non-successes. Participants that had one drug class resistance mutation may have one or more mutations.
Time Frame at the time of virologic failure
Hide Outcome Measure Data
Hide Analysis Population Description
Of the enrolled eligible participants, those with virologic failures had resistance testing done.
Arm/Group Title Arm 1: DTG 50 MG + 3TC 300 mg
Hide Arm/Group Description:

Dolutegravir: Participants were prescribed 50 mg of DTG orally daily

Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.

Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: number of mutation occurrences
NRTI mutation 1
NNRTI mutation 1
INI mutation 1
14.Secondary Outcome
Title Fasting Lipids and Glucose
Hide Description Fasting lipids include: total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol, and glucose. Fasting was set to be 8 hours prior to the sample collection.
Time Frame Baseline and week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible participants enrolled with lipids results available at a given time point.
Arm/Group Title Arm 1: DTG 50 MG + 3TC 300 mg
Hide Arm/Group Description:

Dolutegravir: Participants were prescribed 50 mg of DTG orally daily

Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.

Overall Number of Participants Analyzed 120
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
Baseline Total Cholesterol Number Analyzed 92 participants
151
(123 to 171)
Week 48 Total Cholesterol Number Analyzed 100 participants
154
(136 to 189)
Baseline LDL Cholesterol Number Analyzed 91 participants
85
(69 to 107)
Week 48 LDL Cholesterol Number Analyzed 99 participants
86
(69 to 117)
Baseline HDL Cholesterol Number Analyzed 92 participants
39
(33 to 49)
Week 48 HDL Cholesterol Number Analyzed 100 participants
46
(38 to 56)
Baseline Triglycerides Number Analyzed 92 participants
91
(70 to 133)
Week 48 Triglycerides Number Analyzed 100 participants
98
(60 to 150)
Baseline Glucose Number Analyzed 96 participants
84
(78 to 92)
Week 48 Glucose Number Analyzed 62 participants
86
(81 to 93)
15.Secondary Outcome
Title Creatinine Clearance
Hide Description Creatinine clearance was estimated by the Cockcroft-Gault equation.
Time Frame Baseline, weeks 4, 12, 24, 32, 40 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible participants enrolled with creatinine clearance results available at a given time point.
Arm/Group Title Arm 1: DTG 50 MG + 3TC 300 mg
Hide Arm/Group Description:

Dolutegravir: Participants were prescribed 50 mg of DTG orally daily

Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.

Overall Number of Participants Analyzed 120
Median (Inter-Quartile Range)
Unit of Measure: mL/min
Week 0 Number Analyzed 120 participants
126.0
(106.8 to 139.9)
Week 4 Number Analyzed 116 participants
112.9
(96.6 to 133.2)
Week 12 Number Analyzed 114 participants
112.0
(97.8 to 133.3)
Week 24 Number Analyzed 114 participants
114.7
(96.8 to 132.7)
Week 32 Number Analyzed 111 participants
115.5
(97.1 to 138.6)
Week 40 Number Analyzed 113 participants
112.7
(97.4 to 138.7)
Week 48 Number Analyzed 111 participants
114.4
(101.2 to 133.5)
16.Secondary Outcome
Title Number of Participants With Grade 3 of Higher Adverse Events
Hide Description Number of participants who experienced an AE (sign/symptom or laboratory abnormality) of Grade 3 or higher. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see reference in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening.
Time Frame from study treatment dispensation through up to week 52 or until study discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible participants enrolled.
Arm/Group Title Arm 1: DTG 50 MG + 3TC 300 mg
Hide Arm/Group Description:

Dolutegravir: Participants were prescribed 50 mg of DTG orally daily

Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.

Overall Number of Participants Analyzed 120
Measure Type: Count of Participants
Unit of Measure: Participants
16
  13.3%
Time Frame From study entry through up to week 52 or until study discontinuation
Adverse Event Reporting Description The protocol required reporting of all diagnoses (identified by the ACTG criteria for clinical events and other diseases), signs/symptoms and laboratory values of >= Grade 3 and events that led to a change in treatment or that met ICH, EAE, or SAE guidelines, regardless of grade. Creatinine and creatinine clearance were reported regardless of grade. The DAIDS AE Grading Table (Version 2.0) and Expedited AE Manual (Version 2.0) were used.
 
Arm/Group Title Arm 1: DTG 50 MG + 3TC 300 mg
Hide Arm/Group Description

Dolutegravir: Participants were prescribed 50 mg of DTG orally daily

Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.

All-Cause Mortality
Arm 1: DTG 50 MG + 3TC 300 mg
Affected / at Risk (%)
Total   0/122 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1: DTG 50 MG + 3TC 300 mg
Affected / at Risk (%)
Total   3/122 (2.46%) 
Psychiatric disorders   
Suicidal ideation  1  3/122 (2.46%) 
Suicide attempt  1  1/122 (0.82%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1: DTG 50 MG + 3TC 300 mg
Affected / at Risk (%)
Total   75/122 (61.48%) 
Infections and infestations   
Urethritis gonococcal  1  7/122 (5.74%) 
Investigations   
Alanine aminotransferase increased  1  8/122 (6.56%) 
Aspartate aminotransferase increased  1  10/122 (8.20%) 
Blood cholesterol increased  1  20/122 (16.39%) 
Blood creatinine abnormal  1  10/122 (8.20%) 
Blood glucose increased  1  11/122 (9.02%) 
Blood sodium decreased  1  7/122 (5.74%) 
Blood triglycerides increased  1  30/122 (24.59%) 
Low density lipoprotein increased  1  19/122 (15.57%) 
Neutrophil count decreased  1  12/122 (9.84%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: ACTG Clinicaltrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT02582684     History of Changes
Other Study ID Numbers: ACTG A5353
2UM1AI068636 ( U.S. NIH Grant/Contract )
First Submitted: October 20, 2015
First Posted: October 21, 2015
Results First Submitted: February 28, 2018
Results First Posted: March 30, 2018
Last Update Posted: May 9, 2018