Trial Outcomes & Findings for Safety and Efficacy of Dolutegravir/Lamivudine (DTG/3TC) in Therapy-naive Human Immunodeficiency Virus-1 (HIV-1) Infected Adolescents (NCT NCT03682848)
NCT ID: NCT03682848
Last Updated: 2025-12-09
Results Overview
Percentage of participants with plasma HIV-1 RNA \<50 c/mL was assessed at Week 48 according to the Food and Drug Administration (FDA) snapshot algorithm.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
32 participants
Primary outcome timeframe
Week 48
Results posted on
2025-12-09
Participant Flow
Participant milestones
| Measure |
DTG/3TC FDC
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
DTG/3TC FDC
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Site closed
|
5
|
|
Overall Study
Protocol Deviation
|
1
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
Baseline Characteristics
Safety and Efficacy of Dolutegravir/Lamivudine (DTG/3TC) in Therapy-naive Human Immunodeficiency Virus-1 (HIV-1) Infected Adolescents
Baseline characteristics by cohort
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Age, Continuous
|
16.0 Years
STANDARD_DEVIATION 1.27 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
13 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
19 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: Intent To Treat-Exposed (ITT-E) population includes all enrolled participants who received at least one dose of DTG/3TC.
Percentage of participants with plasma HIV-1 RNA \<50 c/mL was assessed at Week 48 according to the Food and Drug Administration (FDA) snapshot algorithm.
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Less Than 50 Copies Per Milliliter (c/mL) at Week 48
|
81 Percentage of Participants
Interval 64.0 to 93.0
|
SECONDARY outcome
Timeframe: Week 24Population: Intent To Treat-Exposed
Percentage of participants with plasma HIV-1 RNA \<200 c/mL was assessed at Week 24 according to the FDA snapshot algorithm.
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA <200 c/mL at Week 24
|
91 Percentage of Participants
Interval 75.0 to 98.0
|
SECONDARY outcome
Timeframe: Week 96Population: Intent To Treat-Exposed
Percentage of participants with plasma HIV-1 RNA \<200 c/mL was assessed at Week 96 according to the FDA snapshot algorithm.
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA <200 c/mL at Week 96
|
69 Percentage of Participants
Interval 50.0 to 84.0
|
SECONDARY outcome
Timeframe: Week 144Population: Intent To Treat-Exposed
Percentage of participants with plasma HIV-1 RNA \<200 c/mL was assessed at Week 144 according to the FDA snapshot algorithm.
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA <200 c/mL at Week 144
|
66 Percentage of Participants
Interval 47.0 to 81.0
|
SECONDARY outcome
Timeframe: Week 24Population: Intent To Treat-Exposed
Percentage of participants with plasma HIV-1 RNA \<50 c/mL was assessed at Week 24 according to the FDA snapshot algorithm.
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24
|
84 Percentage of Participants
Interval 67.0 to 95.0
|
SECONDARY outcome
Timeframe: Week 96Population: Intent To Treat-Exposed
Percentage of participants with plasma HIV-1 RNA \<50 c/mL was assessed at Week 96 according to the FDA snapshot algorithm.
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96
|
69 Percentage of Participants
Interval 50.0 to 84.0
|
SECONDARY outcome
Timeframe: Week 144Population: Intent To Treat-Exposed
Percentage of participants with plasma HIV-1 RNA \<50 c/mL was assessed at Week 144 according to the FDA Snapshot algorithm.
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144
|
66 Percentage of Participants
Interval 47.0 to 81.0
|
SECONDARY outcome
Timeframe: Week 48Population: Intent To Treat-Exposed
Percentage of participants with plasma HIV-1 RNA \<200 c/mL was assessed at Week 48 according to the FDA snapshot algorithm.
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Percentage of Participants With Plasma HIV-1 RNA <200 c/mL at Week 48
|
84 Percentage of Participants
Interval 67.0 to 95.0
|
SECONDARY outcome
Timeframe: Up to 144 weeksPopulation: Safety population includes participants who have received at least one dose of DTG/3TC.
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A serious adverse event is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Through 144 Weeks
SAEs
|
5 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Through 144 Weeks
AEs
|
29 Participants
|
SECONDARY outcome
Timeframe: Up to 144 weeksPopulation: Safety Population
The Division of Acquired Immunodeficiency Syndrome (DAIDS) criteria for grading the severity of adult and pediatric adverse events was used to assess severity. Grades were defined based on numeric criteria as follows: Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant; Grade 4 - life-threatening consequences; Grade 5 - death. A higher grade indicates a greater severity.
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Number of Participants With AEs Through 144 Weeks by Severity
Grade 1
|
5 Participants
|
|
Number of Participants With AEs Through 144 Weeks by Severity
Grade 2
|
19 Participants
|
|
Number of Participants With AEs Through 144 Weeks by Severity
Grade 3
|
5 Participants
|
|
Number of Participants With AEs Through 144 Weeks by Severity
Grade 4
|
0 Participants
|
|
Number of Participants With AEs Through 144 Weeks by Severity
Grade 5
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 144 weeksPopulation: Safety Population
Blood samples were collected from participants for analysis of hematology parameters including hemoglobin, leukocytes and neutrophils. The DAIDS criteria for grading the severity of adult and pediatric adverse events was used to assess severity. Grades were defined based on numeric criteria as follows: Grade 0 - no abnormality; Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant; Grade 4 - life-threatening consequences.
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Number of Participants With Abnormal Findings for Hematology Parameters Through 144 Weeks
Leukocytes · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters Through 144 Weeks
Leukocytes · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters Through 144 Weeks
Leukocytes · Grade 0
|
30 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters Through 144 Weeks
Neutrophils · Grade 1
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters Through 144 Weeks
Neutrophils · Grade 2
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters Through 144 Weeks
Neutrophils · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters Through 144 Weeks
Neutrophils · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters Through 144 Weeks
Hemoglobin · Grade 1
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters Through 144 Weeks
Hemoglobin · Grade 2
|
4 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters Through 144 Weeks
Hemoglobin · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters Through 144 Weeks
Hemoglobin · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters Through 144 Weeks
Hemoglobin · Grade 0
|
28 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters Through 144 Weeks
Leukocytes · Grade 1
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters Through 144 Weeks
Leukocytes · Grade 2
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters Through 144 Weeks
Neutrophils · Grade 0
|
31 Participants
|
SECONDARY outcome
Timeframe: Up to 144 weeksPopulation: Safety Population
Blood samples were collected from participants for analysis of clinical chemistry parameters including potassium, aspartate aminotransferase, creatinine, alanine aminotransferase (ALT), carbon dioxide, alkaline phosphatase, bilirubin, direct bilirubin, sodium, GFR from creatinine adjusted for BSA, calcium, and creatine kinase. Grades were defined based on numeric criteria as follows: Grade 0 - no abnormality; Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant; Grade 4 - life-threatening consequences.
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Alanine Aminotransferase · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Alanine Aminotransferase · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Alanine Aminotransferase · Grade 0
|
28 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Alkaline Phosphatase · Grade 1
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Alkaline Phosphatase · Grade 2
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Aspartate Aminotransferase · Grade 1
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Aspartate Aminotransferase · Grade 2
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Aspartate Aminotransferase · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Aspartate Aminotransferase · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Bilirubin · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Bilirubin · Grade 0
|
30 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Calcium · Grade 1
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Calcium · Grade 2
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Calcium · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Carbon Dioxide · Grade 1
|
17 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Carbon Dioxide · Grade 2
|
5 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Carbon Dioxide · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Carbon Dioxide · Grade 4
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Carbon Dioxide · Grade 0
|
8 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Creatine Kinase · Grade 1
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Creatine Kinase · Grade 3
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Creatine Kinase · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Direct Bilirubin · Grade 2
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Direct Bilirubin · Grade 3
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
GFR from Creatinine Adjusted for BSA · Grade 2
|
14 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
GFR from Creatinine Adjusted for BSA · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
GFR from Creatinine Adjusted for BSA · Grade 0
|
13 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Potassium · Grade 1
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Potassium · Grade 2
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Potassium · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Potassium · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Sodium · Grade 1
|
6 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Sodium · Grade 0
|
25 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Alanine Aminotransferase · Grade 1
|
3 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Alanine Aminotransferase · Grade 2
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Alkaline Phosphatase · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Alkaline Phosphatase · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Alkaline Phosphatase · Grade 0
|
29 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Aspartate Aminotransferase · Grade 0
|
30 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Bilirubin · Grade 1
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Bilirubin · Grade 2
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Bilirubin · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Calcium · Grade 4
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Calcium · Grade 0
|
30 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Creatine Kinase · Grade 2
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Creatine Kinase · Grade 0
|
26 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Creatinine · Grade 1
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Creatinine · Grade 2
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Creatinine · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Creatinine · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Creatinine · Grade 0
|
30 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Direct Bilirubin · Grade 1
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Direct Bilirubin · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Direct Bilirubin · Grade 0
|
31 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
GFR from Creatinine Adjusted for BSA · Grade 1
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
GFR from Creatinine Adjusted for BSA · Grade 3
|
5 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Potassium · Grade 0
|
30 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Sodium · Grade 2
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Sodium · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 144 Weeks
Sodium · Grade 4
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 144 weeksPopulation: Safety Population
Lipid assessments including cholesterol, low density lipoprotein (LDL) cholesterol, LDL Cholesterol Calculation, LDL Cholesterol Direct, and triglycerides were performed. Grades were defined based on numeric criteria as follows: Grade 0 - no abnormality; Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant; Grade 4 - life-threatening consequences.
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 144 Weeks
Cholesterol · Grade 1
|
7 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 144 Weeks
Cholesterol · Grade 2
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 144 Weeks
Cholesterol · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 144 Weeks
Cholesterol · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 144 Weeks
Cholesterol · Grade 0
|
24 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 144 Weeks
LDL Cholesterol · Grade 1
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 144 Weeks
LDL Cholesterol · Grade 2
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 144 Weeks
LDL Cholesterol · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 144 Weeks
LDL Cholesterol · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 144 Weeks
LDL Cholesterol · Grade 0
|
30 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 144 Weeks
LDL Cholesterol Calculation · Grade 1
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 144 Weeks
LDL Cholesterol Calculation · Grade 2
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 144 Weeks
LDL Cholesterol Calculation · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 144 Weeks
LDL Cholesterol Calculation · Grade 0
|
30 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 144 Weeks
LDL Cholesterol Direct · Grade 1
|
6 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 144 Weeks
LDL Cholesterol Direct · Grade 2
|
3 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 144 Weeks
LDL Cholesterol Direct · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 144 Weeks
LDL Cholesterol Direct · Grade 0
|
23 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 144 Weeks
Triglycerides · Grade 0
|
27 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 144 Weeks
Triglycerides · Grade 2
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 144 Weeks
LDL Cholesterol Calculation · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 144 Weeks
LDL Cholesterol Direct · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 144 Weeks
Triglycerides · Grade 1
|
5 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 144 Weeks
Triglycerides · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 144 Weeks
Triglycerides · Grade 4
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 144 weeksPopulation: Safety Population
Urine samples were collected from participants for the analysis of urinalysis parameters including urinary glucose, urinary protein, and urine erythrocytes. Grades were defined based on numeric criteria as follows: Grade 0 - no abnormality; Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant; Grade 4 - life-threatening consequences.
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 144 Weeks
Urinary Glucose · Grade 1
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 144 Weeks
Urinary Glucose · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 144 Weeks
Urinary Glucose · Grade 0
|
31 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 144 Weeks
Urinary Protein · Grade 1
|
5 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 144 Weeks
Urinary Protein · Grade 2
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 144 Weeks
Urinary Protein · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 144 Weeks
Urinary Protein · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 144 Weeks
Urinary Protein · Grade 0
|
25 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 144 Weeks
Urine Erythrocytes · Grade 1
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 144 Weeks
Urine Erythrocytes · Grade 2
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 144 Weeks
Urine Erythrocytes · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 144 Weeks
Urine Erythrocytes · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 144 Weeks
Urine Erythrocytes · Grade 0
|
30 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 144 Weeks
Urinary Glucose · Grade 2
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 144 Weeks
Urinary Glucose · Grade 3
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 144 weeksPopulation: Safety Population
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Number of Participants Who Discontinue Treatment Due to Adverse Events Through 144 Weeks
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 96 weeksPopulation: Safety Population
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Number of Participants With Adverse Events and Serious Adverse Events Through 96 Weeks
AEs
|
29 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events Through 96 Weeks
SAEs
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 96 weeksPopulation: Safety Population
AEs were evaluated by the investigator and graded according to the DAIDS toxicity scales as follows: Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant; Grade 4 - life-threatening consequences; Grade 5 - death. The higher the grade, the more severe the symptoms.
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Number of Participants With Severity of Adverse Events Through 96 Weeks
Grade 3
|
2 Participants
|
|
Number of Participants With Severity of Adverse Events Through 96 Weeks
Grade 4
|
0 Participants
|
|
Number of Participants With Severity of Adverse Events Through 96 Weeks
Grade 5
|
0 Participants
|
|
Number of Participants With Severity of Adverse Events Through 96 Weeks
Grade 1
|
8 Participants
|
|
Number of Participants With Severity of Adverse Events Through 96 Weeks
Grade 2
|
19 Participants
|
SECONDARY outcome
Timeframe: Up to 96 weeksPopulation: Safety Population
Blood samples were collected from participants for analysis of hematology parameters including hemoglobin, leukocytes and neutrophils. Grades were defined based on numeric criteria as follows: Grade 0 - no abnormality; Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant; Grade 4 - life-threatening consequences.
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Number of Participants With Abnormal Findings for Hematology Parameters Through 96 Weeks
Hemoglobin · Grade 1
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters Through 96 Weeks
Hemoglobin · Grade 2
|
4 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters Through 96 Weeks
Neutrophils · Grade 2
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters Through 96 Weeks
Neutrophils · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters Through 96 Weeks
Neutrophils · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters Through 96 Weeks
Neutrophils · Grade 0
|
31 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters Through 96 Weeks
Hemoglobin · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters Through 96 Weeks
Hemoglobin · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters Through 96 Weeks
Hemoglobin · Grade 0
|
28 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters Through 96 Weeks
Leukocytes · Grade 1
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters Through 96 Weeks
Leukocytes · Grade 2
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters Through 96 Weeks
Leukocytes · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters Through 96 Weeks
Leukocytes · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters Through 96 Weeks
Leukocytes · Grade 0
|
30 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters Through 96 Weeks
Neutrophils · Grade 1
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 96 weeksPopulation: Safety Population
Blood samples were collected from participants for analysis of clinical chemistry parameters including potassium, aspartate aminotransferase, creatinine, alanine aminotransferase, carbon dioxide, alkaline phosphatase, bilirubin, sodium, GFR from creatinine adjusted for BSA, calcium, and creatine kinase. Grades were defined based on numeric criteria as follows: Grade 0 - no abnormality; Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant; Grade 4 - life-threatening consequences.
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Alanine Aminotransferase · Grade 1
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Alanine Aminotransferase · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Alanine Aminotransferase · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Alanine Aminotransferase · Grade 0
|
29 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Alkaline Phosphatase · Grade 1
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Alkaline Phosphatase · Grade 2
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Alkaline Phosphatase · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Alkaline Phosphatase · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Alkaline Phosphatase · Grade 0
|
29 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Aspartate Aminotransferase · Grade 1
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Aspartate Aminotransferase · Grade 2
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Aspartate Aminotransferase · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Aspartate Aminotransferase · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Aspartate Aminotransferase · Grade 0
|
30 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Bilirubin · Grade 1
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Bilirubin · Grade 2
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Bilirubin · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Calcium · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Calcium · Grade 4
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Calcium · Grade 0
|
30 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Carbon Dioxide · Grade 1
|
14 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Carbon Dioxide · Grade 2
|
5 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Carbon Dioxide · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Carbon Dioxide · Grade 4
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Carbon Dioxide · Grade 0
|
11 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Creatine Kinase · Grade 2
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Creatine Kinase · Grade 3
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Creatine Kinase · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Creatinine · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Creatinine · Grade 0
|
30 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
GFR from Creatinine Adjusted for BSA · Grade 1
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
GFR from Creatinine Adjusted for BSA · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
GFR from Creatinine Adjusted for BSA · Grade 0
|
14 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Potassium · Grade 1
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Potassium · Grade 2
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Potassium · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Sodium · Grade 1
|
5 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Sodium · Grade 2
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Sodium · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Sodium · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Sodium · Grade 0
|
26 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Bilirubin · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Bilirubin · Grade 0
|
30 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Calcium · Grade 1
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Calcium · Grade 2
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Creatine Kinase · Grade 1
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Creatine Kinase · Grade 0
|
27 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Creatinine · Grade 1
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Creatinine · Grade 2
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Creatinine · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
GFR from Creatinine Adjusted for BSA · Grade 2
|
13 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
GFR from Creatinine Adjusted for BSA · Grade 3
|
5 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Potassium · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Potassium · Grade 0
|
30 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters Through 96 Weeks
Alanine Aminotransferase · Grade 2
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 96 weeksPopulation: Safety Population
Lipid assessments including cholesterol, LDL cholesterol, LDL cholesterol calculation, LDL cholesterol direct, and triglycerides were performed. Grades were defined based on numeric criteria as follows: Grade 0 - no abnormality; Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant; Grade 4 - life-threatening consequences.
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 96 Weeks
LDL Cholesterol · Grade 0
|
30 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 96 Weeks
LDL Cholesterol Calculation · Grade 1
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 96 Weeks
LDL Cholesterol Calculation · Grade 2
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 96 Weeks
Cholesterol · Grade 1
|
7 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 96 Weeks
Cholesterol · Grade 2
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 96 Weeks
Cholesterol · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 96 Weeks
Cholesterol · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 96 Weeks
Cholesterol · Grade 0
|
24 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 96 Weeks
LDL Cholesterol · Grade 1
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 96 Weeks
LDL Cholesterol · Grade 2
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 96 Weeks
LDL Cholesterol · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 96 Weeks
LDL Cholesterol · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 96 Weeks
LDL Cholesterol Calculation · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 96 Weeks
LDL Cholesterol Calculation · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 96 Weeks
LDL Cholesterol Calculation · Grade 0
|
31 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 96 Weeks
LDL Cholesterol Direct · Grade 1
|
6 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 96 Weeks
LDL Cholesterol Direct · Grade 2
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 96 Weeks
LDL Cholesterol Direct · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 96 Weeks
LDL Cholesterol Direct · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 96 Weeks
LDL Cholesterol Direct · Grade 0
|
24 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 96 Weeks
Triglycerides · Grade 1
|
4 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 96 Weeks
Triglycerides · Grade 2
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 96 Weeks
Triglycerides · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 96 Weeks
Triglycerides · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids Through 96 Weeks
Triglycerides · Grade 0
|
28 Participants
|
SECONDARY outcome
Timeframe: Up to 96 weeksPopulation: Safety Population
Urine samples will be collected from participants for the analysis of urinalysis parameters including urinary glucose, urinary protein, and urine erythrocytes. Grades were defined based on numeric criteria as follows: Grade 0 - no abnormality; Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant; Grade 4 - life-threatening consequences.
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 96 Weeks
Urinary Glucose · Grade 1
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 96 Weeks
Urinary Glucose · Grade 2
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 96 Weeks
Urinary Glucose · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 96 Weeks
Urinary Glucose · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 96 Weeks
Urinary Glucose · Grade 0
|
31 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 96 Weeks
Urinary Protein · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 96 Weeks
Urinary Protein · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 96 Weeks
Urine Erythrocytes · Grade 1
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 96 Weeks
Urine Erythrocytes · Grade 2
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 96 Weeks
Urine Erythrocytes · Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 96 Weeks
Urine Erythrocytes · Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 96 Weeks
Urinary Protein · Grade 1
|
3 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 96 Weeks
Urinary Protein · Grade 2
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 96 Weeks
Urinary Protein · Grade 0
|
27 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters Through 96 Weeks
Urine Erythrocytes · Grade 0
|
30 Participants
|
SECONDARY outcome
Timeframe: Weeks 48, 60, 72, 84, 96, 108, 120, 132, and 144Population: Safety Population
Viral load was defined as plasma HIV-RNA \<50 copies per mL. Viral load monitoring of participants was performed from Week 48 through 144 weeks.
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Number of Participants Undergoing Viral Load Monitoring From Week 48 Through 144 Weeks
Week 120
|
21 Participants
|
|
Number of Participants Undergoing Viral Load Monitoring From Week 48 Through 144 Weeks
Week 132
|
21 Participants
|
|
Number of Participants Undergoing Viral Load Monitoring From Week 48 Through 144 Weeks
Week 144
|
21 Participants
|
|
Number of Participants Undergoing Viral Load Monitoring From Week 48 Through 144 Weeks
Week 48
|
28 Participants
|
|
Number of Participants Undergoing Viral Load Monitoring From Week 48 Through 144 Weeks
Week 60
|
27 Participants
|
|
Number of Participants Undergoing Viral Load Monitoring From Week 48 Through 144 Weeks
Week 72
|
23 Participants
|
|
Number of Participants Undergoing Viral Load Monitoring From Week 48 Through 144 Weeks
Week 84
|
23 Participants
|
|
Number of Participants Undergoing Viral Load Monitoring From Week 48 Through 144 Weeks
Week 96
|
23 Participants
|
|
Number of Participants Undergoing Viral Load Monitoring From Week 48 Through 144 Weeks
Week 108
|
21 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 24 and 48Population: Intent-To-Treat Exposed. Only those participants with data available at specified time points were analyzed.
Baseline value was defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count at Weeks 24 and 48
Baseline (Day 1)
|
371.500 10^6 cells per liter
Interval 270.0 to 507.5
|
|
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count at Weeks 24 and 48
Week 24
|
167.000 10^6 cells per liter
Interval 103.0 to 319.0
|
|
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count at Weeks 24 and 48
Week 48
|
223.500 10^6 cells per liter
Interval 85.5 to 380.5
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 24 and 48Population: Intent-To-Treat Exposed. Only those participants with data available at specified time points were analyzed.
Baseline value was defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Change From Baseline in CD8+ Cell Count at Weeks 24 and 48
Week 48
|
-78.500 10^6 cells per liter
Interval -243.0 to 176.0
|
|
Change From Baseline in CD8+ Cell Count at Weeks 24 and 48
Week 24
|
-15.000 10^6 cells per liter
Interval -117.0 to 301.0
|
|
Change From Baseline in CD8+ Cell Count at Weeks 24 and 48
Baseline (Day 1)
|
828.000 10^6 cells per liter
Interval 679.5 to 1031.5
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 24 and 48Population: Intent-To-Treat Exposed. Only those participants with data available at specified time points were analyzed.
Baseline value was defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Change From Baseline in Ratio of CD4+ and CD8+ at Weeks 24 and 48
Baseline (Day 1)
|
0.395 Ratio
Interval 0.33 to 0.64
|
|
Change From Baseline in Ratio of CD4+ and CD8+ at Weeks 24 and 48
Week 24
|
0.215 Ratio
Interval 0.14 to 0.3
|
|
Change From Baseline in Ratio of CD4+ and CD8+ at Weeks 24 and 48
Week 48
|
0.345 Ratio
Interval 0.24 to 0.49
|
SECONDARY outcome
Timeframe: Week 24 and up to Week 48Population: Safety Population
Participants with disease progression included incidences of HIV-associated conditions, Acquired Immuno Deficiency Syndrome (AIDS) and death. HIV-associated conditions were assessed according to the 2014 HIV infection by Centers for Disease Control and Prevention (CDC) classification system for HIV Infection in adults to evaluate the immune effects of DTG /3TC FDC.
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Number of Participants With Disease Progression From Week 24 Through Week 48
Week 24
|
0 Participants
|
|
Number of Participants With Disease Progression From Week 24 Through Week 48
Week 48
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 24 and up to Week 48Population: Safety Population
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Number of Participants With Any Adverse Events and Serious Adverse Events From Week 24 Through Week 48
AEs (Week 24)
|
23 Participants
|
|
Number of Participants With Any Adverse Events and Serious Adverse Events From Week 24 Through Week 48
AEs (Week 48)
|
28 Participants
|
|
Number of Participants With Any Adverse Events and Serious Adverse Events From Week 24 Through Week 48
SAEs (Week 24)
|
1 Participants
|
|
Number of Participants With Any Adverse Events and Serious Adverse Events From Week 24 Through Week 48
SAEs (Week 48)
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 24 and up to Week 48Population: Safety Population
AEs were evaluated by the investigator and graded according to the DAIDS toxicity scales as follows: Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant; Grade 4 - life-threatening consequences; Grade 5 - death. The higher the grade, the more severe the symptoms.
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Number of Participants With Severity of Adverse Events From Week 24 Through Week 48
Grade 1 (Week 24)
|
9 Participants
|
|
Number of Participants With Severity of Adverse Events From Week 24 Through Week 48
Grade 2 (Week 24)
|
13 Participants
|
|
Number of Participants With Severity of Adverse Events From Week 24 Through Week 48
Grade 2 (Week 48)
|
16 Participants
|
|
Number of Participants With Severity of Adverse Events From Week 24 Through Week 48
Grade 3 (Week 48)
|
1 Participants
|
|
Number of Participants With Severity of Adverse Events From Week 24 Through Week 48
Grade 4 (Week 48)
|
0 Participants
|
|
Number of Participants With Severity of Adverse Events From Week 24 Through Week 48
Grade 5 (Week 48)
|
0 Participants
|
|
Number of Participants With Severity of Adverse Events From Week 24 Through Week 48
Grade 3 (Week 24)
|
1 Participants
|
|
Number of Participants With Severity of Adverse Events From Week 24 Through Week 48
Grade 4 (Week 24)
|
0 Participants
|
|
Number of Participants With Severity of Adverse Events From Week 24 Through Week 48
Grade 5 (Week 24)
|
0 Participants
|
|
Number of Participants With Severity of Adverse Events From Week 24 Through Week 48
Grade 1 (Week 48)
|
11 Participants
|
SECONDARY outcome
Timeframe: Week 24 and up to Week 48Population: Safety Population
Blood samples were collected from participants for analysis of hematology parameters including hemoglobin, leukocytes and neutrophils. Grades were defined based on numeric criteria as follows: Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant; Grade 4 - life-threatening consequences.
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Number of Participants With Abnormal Findings for Hematology Parameters From Week 24 Through Week 48
Hemoglobin - Grade 4 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters From Week 24 Through Week 48
Leukocytes - Grade 1 (Week 24)
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters From Week 24 Through Week 48
Leukocytes - Grade 2 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters From Week 24 Through Week 48
Leukocytes - Grade 3 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters From Week 24 Through Week 48
Leukocytes - Grade 4 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters From Week 24 Through Week 48
Neutrophils - Grade 1 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters From Week 24 Through Week 48
Neutrophils - Grade 3 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters From Week 24 Through Week 48
Hemoglobin - Grade 3 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters From Week 24 Through Week 48
Hemoglobin - Grade 4 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters From Week 24 Through Week 48
Leukocytes - Grade 1 (Week 48)
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters From Week 24 Through Week 48
Leukocytes - Grade 2 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters From Week 24 Through Week 48
Leukocytes - Grade 3 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters From Week 24 Through Week 48
Leukocytes - Grade 4 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters From Week 24 Through Week 48
Neutrophils - Grade 1 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters From Week 24 Through Week 48
Neutrophils - Grade 3 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters From Week 24 Through Week 48
Neutrophils - Grade 4 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters From Week 24 Through Week 48
Hemoglobin - Grade 1 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters From Week 24 Through Week 48
Hemoglobin - Grade 2 (Week 24)
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters From Week 24 Through Week 48
Hemoglobin - Grade 3 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters From Week 24 Through Week 48
Neutrophils - Grade 2 (Week 24)
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters From Week 24 Through Week 48
Neutrophils - Grade 4 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters From Week 24 Through Week 48
Hemoglobin - Grade 1 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters From Week 24 Through Week 48
Hemoglobin - Grade 2 (Week 48)
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Hematology Parameters From Week 24 Through Week 48
Neutrophils - Grade 2 (Week 48)
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 24 and up to Week 48Population: Safety Population
Blood samples were collected from participants for analysis of clinical chemistry parameters including potassium, aspartate aminotransferase, creatinine, alanine aminotransferase, carbon dioxide, alkaline phosphatase, bilirubin, sodium, GFR from creatinine adjusted for BSA, calcium, and creatine kinase. Grades were defined based on numeric criteria as follows: Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant; Grade 4 - life-threatening consequences.
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Alanine Aminotransferase - Grade 1 (Week 24)
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Alanine Aminotransferase - Grade 2 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Alanine Aminotransferase - Grade 3 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Alanine Aminotransferase - Grade 4 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Alkaline Phosphatase - Grade 1 (Week 24)
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Alkaline Phosphatase - Grade 2 (Week 24)
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Alkaline Phosphatase - Grade 3 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Alkaline Phosphatase - Grade 4 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Aspartate Aminotransferase - Grade 1 (Week 24)
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Aspartate Aminotransferase - Grade 2 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Aspartate Aminotransferase - Grade 3 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Aspartate Aminotransferase - Grade 4 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Bilirubin - Grade 1 (Week 24)
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Bilirubin - Grade 3 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Bilirubin - Grade 4 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Calcium - Grade 1 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Calcium - Grade 2 (Week 24)
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Calcium - Grade 3 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Calcium - Grade 4 (Week 24)
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Carbon Dioxide - Grade 1 (Week 24)
|
11 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Carbon Dioxide - Grade 3 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Carbon Dioxide - Grade 4 (Week 24)
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Creatine Kinase - Grade 2 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Creatine Kinase - Grade 3 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Creatine Kinase - Grade 4 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Creatinine - Grade 2 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
GFR from Creatinine Adjusted for BSA - Grade 1 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
GFR from Creatinine Adjusted for BSA - Grade 2 (Week 24)
|
12 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
GFR from Creatinine Adjusted for BSA - Grade 4 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Potassium - Grade 2 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Potassium - Grade 3 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Sodium - Grade 3 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Sodium - Grade 4 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Alanine Aminotransferase - Grade 1 (Week 48)
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Alanine Aminotransferase - Grade 2 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Alanine Aminotransferase - Grade 3 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Alanine Aminotransferase - Grade 4 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Alkaline Phosphatase - Grade 2 (Week 48)
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Alkaline Phosphatase - Grade 3 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Alkaline Phosphatase - Grade 4 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Aspartate Aminotransferase - Grade 1 (Week 48)
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Aspartate Aminotransferase - Grade 2 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Aspartate Aminotransferase - Grade 3 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Aspartate Aminotransferase - Grade 4 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Bilirubin - Grade 1 (Week 48)
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Bilirubin - Grade 2 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Bilirubin - Grade 3 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Bilirubin - Grade 4 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Calcium - Grade 1 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Calcium - Grade 2 (Week 48)
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Calcium - Grade 3 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Calcium - Grade 4 (Week 48)
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Carbon Dioxide - Grade 1 (Week 48)
|
12 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Carbon Dioxide - Grade 2 (Week 48)
|
5 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Carbon Dioxide - Grade 3 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Creatine Kinase - Grade 2 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Creatine Kinase - Grade 3 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Creatinine - Grade 1 (Week 48)
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Creatinine - Grade 2 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Creatinine - Grade 4 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
GFR from Creatinine Adjusted for BSA - Grade 2 (Week 48)
|
13 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
GFR from Creatinine Adjusted for BSA - Grade 3 (Week 48)
|
6 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Potassium - Grade 2 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Potassium - Grade 3 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Potassium - Grade 4 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Sodium - Grade 3 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Sodium - Grade 4 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Bilirubin - Grade 2 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Carbon Dioxide - Grade 2 (Week 24)
|
4 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Creatine Kinase - Grade 1 (Week 24)
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Creatinine - Grade 1 (Week 24)
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Creatinine - Grade 3 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Creatinine - Grade 4 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
GFR from Creatinine Adjusted for BSA - Grade 3 (Week 24)
|
3 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Potassium - Grade 1 (Week 24)
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Potassium - Grade 4 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Sodium - Grade 1 (Week 24)
|
5 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Sodium - Grade 2 (Week 24)
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Alkaline Phosphatase - Grade 1 (Week 48)
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Carbon Dioxide - Grade 4 (Week 48)
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Creatine Kinase - Grade 1 (Week 48)
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Creatine Kinase - Grade 4 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Creatinine - Grade 3 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
GFR from Creatinine Adjusted for BSA - Grade 1 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
GFR from Creatinine Adjusted for BSA - Grade 4 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Potassium - Grade 1 (Week 48)
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Sodium - Grade 1 (Week 48)
|
5 Participants
|
|
Number of Participants With Abnormal Findings for Clinical Chemistry Parameters From Week 24 Through Week 48
Sodium - Grade 2 (Week 48)
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 24 and up to Week 48Population: Safety Population
Lipid assessments including cholesterol, LDL cholesterol, LDL cholesterol calculation, LDL cholesterol direct, and triglycerides were performed. Grades were defined based on numeric criteria as follows: Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant; Grade 4 - life-threatening consequences.
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Number of Participants With Abnormal Findings for Fasting Lipids From Week 24 Through Week 48
LDL cholesterol - Grade 3 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids From Week 24 Through Week 48
LDL cholesterol - Grade 4 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids From Week 24 Through Week 48
Triglycerides - Grade 1 (Week 24)
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids From Week 24 Through Week 48
Cholesterol - Grade 3 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids From Week 24 Through Week 48
Triglycerides - Grade 2 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids From Week 24 Through Week 48
Triglycerides - Grade 3 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids From Week 24 Through Week 48
Triglycerides - Grade 4 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids From Week 24 Through Week 48
LDL cholesterol - Grade 1 (Week 48)
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids From Week 24 Through Week 48
LDL cholesterol - Grade 2 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids From Week 24 Through Week 48
LDL cholesterol - Grade 3 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids From Week 24 Through Week 48
LDL cholesterol - Grade 4 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids From Week 24 Through Week 48
Triglycerides - Grade 1 (Week 48)
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids From Week 24 Through Week 48
Triglycerides - Grade 2 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids From Week 24 Through Week 48
Cholesterol - Grade 1 (Week 24)
|
2 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids From Week 24 Through Week 48
Cholesterol - Grade 2 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids From Week 24 Through Week 48
Cholesterol - Grade 4 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids From Week 24 Through Week 48
LDL cholesterol - Grade 1 (Week 24)
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids From Week 24 Through Week 48
LDL cholesterol - Grade 2 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids From Week 24 Through Week 48
Triglycerides - Grade 3 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids From Week 24 Through Week 48
Triglycerides - Grade 4 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids From Week 24 Through Week 48
Cholesterol - Grade 1 (Week 48)
|
5 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids From Week 24 Through Week 48
Cholesterol - Grade 2 (Week 48)
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids From Week 24 Through Week 48
Cholesterol - Grade 3 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Fasting Lipids From Week 24 Through Week 48
Cholesterol - Grade 4 (Week 48)
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 24 and up to Week 48Population: Safety Population
Urine samples will be collected from participants for the analysis of urinalysis parameters including urinary glucose, urinary protein, and urine erythrocytes. Grades were defined based on numeric criteria as follows: Grade 1 - mild; Grade 2 - moderate; Grade 3 - severe or medically significant; Grade 4 - life-threatening consequences.
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters From Week 24 Through Week 48
Urinary Glucose - Grade 1 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters From Week 24 Through Week 48
Urinary Protein - Grade 1 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters From Week 24 Through Week 48
Urinary Protein - Grade 2 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters From Week 24 Through Week 48
Urinary Protein - Grade 3 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters From Week 24 Through Week 48
Urinary Protein - Grade 2 (Week 48)
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters From Week 24 Through Week 48
Urinary Protein - Grade 3 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters From Week 24 Through Week 48
Urinary Glucose - Grade 2 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters From Week 24 Through Week 48
Urinary Glucose - Grade 3 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters From Week 24 Through Week 48
Urinary Glucose - Grade 4 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters From Week 24 Through Week 48
Urinary Protein - Grade 4 (Week 24)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters From Week 24 Through Week 48
Urinary Glucose - Grade 1 (Week 48)
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters From Week 24 Through Week 48
Urinary Glucose - Grade 2 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters From Week 24 Through Week 48
Urinary Glucose - Grade 3 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters From Week 24 Through Week 48
Urinary Glucose - Grade 4 (Week 48)
|
0 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters From Week 24 Through Week 48
Urinary Protein - Grade 1 (Week 48)
|
1 Participants
|
|
Number of Participants With Abnormal Findings for Urinalysis Parameters From Week 24 Through Week 48
Urinary Protein - Grade 4 (Week 48)
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 24 and up to Week 48Population: Safety Population
Outcome measures
| Measure |
DTG/3TC FDC
n=32 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Number of Participants Who Discontinued Treatment Due to Adverse Events From Week 24 Through Week 48
Week 24
|
1 Participants
|
|
Number of Participants Who Discontinued Treatment Due to Adverse Events From Week 24 Through Week 48
Week 48
|
1 Participants
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1.0, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose at Week 1Population: Intensive Pharmacokinetic Population includes all participants who received at least 1 dose of DTG/3TC FDC and have evaluable drug concentrations reported, where samples are collected according to the intensive sampling schedule.
Blood samples were collected on a subset of participants for intensive pharmacokinetic analysis.
Outcome measures
| Measure |
DTG/3TC FDC
n=12 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Maximum Observed Plasma Concentration (Cmax) Following Dosing With DTG and 3TC
Maximum observed plasma concentration - DTG
|
5354.870 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 25.02
|
|
Maximum Observed Plasma Concentration (Cmax) Following Dosing With DTG and 3TC
Maximum observed plasma concentration - 3TC
|
2778.555 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 27.80
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1.0, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose at Week 1Population: Intensive Pharmacokinetic Population
Blood samples were collected on a subset of participants for intensive pharmacokinetic analysis.
Outcome measures
| Measure |
DTG/3TC FDC
n=12 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Time of Maximum Observed Plasma Concentration (Tmax) Following Dosing With DTG and 3TC
Time of maximum observed plasma concentration - 3TC
|
1.000 Hours
Interval 1.0 to 3.0
|
|
Time of Maximum Observed Plasma Concentration (Tmax) Following Dosing With DTG and 3TC
Time of maximum observed plasma concentration - DTG
|
2.000 Hours
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1.0, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose at Week 1Population: Intensive Pharmacokinetic Population
Blood samples were collected on a subset of participants for intensive pharmacokinetic analysis.
Outcome measures
| Measure |
DTG/3TC FDC
n=12 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC[0-t]) Following Dosing With DTG and 3TC
AUC[0-t] - DTG
|
74001.76 hours*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 23.2
|
|
Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC[0-t]) Following Dosing With DTG and 3TC
AUC[0-t] - 3TC
|
12277.62 hours*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 17.7
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1.0, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose at Week 1Population: Intensive Pharmacokinetic Population
Blood samples were collected on a subset of participants for intensive pharmacokinetic analysis.
Outcome measures
| Measure |
DTG/3TC FDC
n=12 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Area Under the Curve (AUC) Over the Dosing Interval (AUC[0-tau]) Following Dosing With DTG and 3TC
AUC[0-tau] - DTG
|
74001.76 hours*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 23.2
|
|
Area Under the Curve (AUC) Over the Dosing Interval (AUC[0-tau]) Following Dosing With DTG and 3TC
AUC[0-tau] - 3TC
|
12277.62 hours*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 17.7
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1.0, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose at Week 1Population: Intensive Pharmacokinetic Population
Blood samples were collected on a subset of participants for intensive pharmacokinetic analysis.
Outcome measures
| Measure |
DTG/3TC FDC
n=12 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Apparent Terminal Half-life (t1/2) Following Dosing With DTG and 3TC
Apparent terminal half-life - DTG
|
12.910 Hours
Geometric Coefficient of Variation 15.35
|
|
Apparent Terminal Half-life (t1/2) Following Dosing With DTG and 3TC
Apparent terminal half-life - 3TC
|
4.823 Hours
Geometric Coefficient of Variation 13.26
|
SECONDARY outcome
Timeframe: Pre-dose at Week 1Population: Intensive Pharmacokinetic Population
Blood samples were collected on a subset of participants for intensive pharmacokinetic analysis.
Outcome measures
| Measure |
DTG/3TC FDC
n=12 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Observed Pre-dose Plasma Concentration Following Dosing With DTG and 3TC
DTG
|
1636.791 ng/mL
Geometric Coefficient of Variation 39.26
|
|
Observed Pre-dose Plasma Concentration Following Dosing With DTG and 3TC
3TC
|
51.073 ng/mL
Geometric Coefficient of Variation 60.88
|
SECONDARY outcome
Timeframe: 24 hours post-dose at Week 1Population: Intensive Pharmacokinetic Population
Blood samples were collected on a subset of participants for intensive pharmacokinetic analysis.
Outcome measures
| Measure |
DTG/3TC FDC
n=12 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Observed Plasma Concentration at 24 Hours Following Dosing With DTG and 3TC
DTG
|
1635.606 ng/mL
Geometric Coefficient of Variation 25.36
|
|
Observed Plasma Concentration at 24 Hours Following Dosing With DTG and 3TC
3TC
|
53.453 ng/mL
Geometric Coefficient of Variation 33.42
|
SECONDARY outcome
Timeframe: Up to 144 weeksPopulation: The analysis used the CVW population, comprising ITT-E participants meeting CVW criteria: confirmed virologic non-response (HIV-1 RNA \<1 log10 c/mL at/after Week 12 or =200 c/mL at/after Week 24) or confirmed rebound (HIV-1 RNA =200 c/mL after prior suppression \<200 c/mL).
Protocol-defined confirmed virologic withdrawal (CVW) through Week 144 was low with 1 participant meeting CVW criteria. Resistance testing failed, and therefore no genotypic data were available for this participant at the time of virologic failure.
Outcome measures
| Measure |
DTG/3TC FDC
n=1 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Number of Participants With Observed Genotypic Resistance to DTG and 3TC
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 144 weeksPopulation: CVW Population
Protocol-defined CVW through Week 144 was low with 1 participant meeting CVW criteria. Resistance testing failed, and therefore no phenotypic data were available for this participant at the time of virologic failure.
Outcome measures
| Measure |
DTG/3TC FDC
n=1 Participants
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Number of Participants With Observed Phenotypic Resistance to DTG and 3TC
|
0 Participants
|
Adverse Events
DTG/3TC FDC
Serious events: 5 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DTG/3TC FDC
n=32 participants at risk
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Infections and infestations
Anal abscess
|
3.1%
1/32 • Number of events 1 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulvovaginal warts
|
3.1%
1/32 • Number of events 1 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Infections and infestations
Orchitis
|
3.1%
1/32 • Number of events 1 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Eye disorders
Ulcerative keratitis
|
3.1%
1/32 • Number of events 1 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
3.1%
1/32 • Number of events 1 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Psychiatric disorders
Major depression
|
3.1%
1/32 • Number of events 1 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
Other adverse events
| Measure |
DTG/3TC FDC
n=32 participants at risk
Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.
|
|---|---|
|
Gastrointestinal disorders
Food poisoning
|
6.2%
2/32 • Number of events 3 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
4/32 • Number of events 4 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Immune system disorders
Hypersensitivity
|
6.2%
2/32 • Number of events 2 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
2/32 • Number of events 3 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
2/32 • Number of events 3 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Psychiatric disorders
Depression
|
6.2%
2/32 • Number of events 2 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Psychiatric disorders
Suicidal ideation
|
6.2%
2/32 • Number of events 2 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
6.2%
2/32 • Number of events 2 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Investigations
Glomerular filtration rate decreased
|
6.2%
2/32 • Number of events 3 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Gastrointestinal disorders
Aphthous ulcer
|
6.2%
2/32 • Number of events 3 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
8/32 • Number of events 10 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Infections and infestations
Folliculitis
|
9.4%
3/32 • Number of events 3 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Infections and infestations
Upper respiratory tract infection
|
18.8%
6/32 • Number of events 7 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Infections and infestations
Genital herpes
|
6.2%
2/32 • Number of events 2 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Infections and infestations
Pharyngitis
|
15.6%
5/32 • Number of events 5 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Infections and infestations
Vulvovaginal candidiasis
|
6.2%
2/32 • Number of events 2 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Respiratory, thoracic and mediastinal disorders
Allergic cough
|
6.2%
2/32 • Number of events 2 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
6.2%
2/32 • Number of events 2 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.2%
2/32 • Number of events 2 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Nervous system disorders
Headache
|
12.5%
4/32 • Number of events 5 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Infections and infestations
COVID-19
|
31.2%
10/32 • Number of events 16 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Infections and infestations
Herpes zoster
|
6.2%
2/32 • Number of events 2 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Infections and infestations
Tonsillitis
|
9.4%
3/32 • Number of events 3 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Infections and infestations
Urinary tract infection
|
6.2%
2/32 • Number of events 2 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
6.2%
2/32 • Number of events 2 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Infections and infestations
Secondary syphilis
|
9.4%
3/32 • Number of events 4 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Infections and infestations
Impetigo
|
6.2%
2/32 • Number of events 2 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Infections and infestations
Urethritis
|
6.2%
2/32 • Number of events 2 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
2/32 • Number of events 2 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
6.2%
2/32 • Number of events 3 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.2%
2/32 • Number of events 2 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
|
General disorders
Influenza like illness
|
9.4%
3/32 • Number of events 6 • All-Cause mortality, Non-SAEs and SAEs were collected from Day 1 up to Week 144
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER