Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of the Pharmacokinetics and Antiviral Activity of Dolutegravir in the Central Nervous System in HIV-1 Infected ART-naive Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01499199
Recruitment Status : Completed
First Posted : December 26, 2011
Results First Posted : November 25, 2013
Last Update Posted : February 25, 2015
Sponsor:
Collaborators:
Shionogi
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Infection, Human Immunodeficiency Virus
Intervention Drug: Dolutegravir
Enrollment 13
Recruitment Details  
Pre-assignment Details Eligible participants received dolutegravir (DTG ) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) for 96 weeks.
Arm/Group Title Dolutegravir 50 mg OD
Hide Arm/Group Description Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
Period Title: Overall Study
Started 13
Completed 11
Not Completed 2
Reason Not Completed
Adverse Event             1
Lack of Efficacy             1
Arm/Group Title Dolutegravir 50 mg OD
Hide Arm/Group Description Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
40.2  (6.90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
0
   0.0%
Male
13
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
White Number Analyzed 13 participants
13
Baseline plasma human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA)   [1] 
Median (Full Range)
Unit of measure:  Log10 copies/mL
Number Analyzed 13 participants
4.73
(3.60 to 6.57)
[1]
Measure Description: The absolute value of plasma HIV-1 RNA was measured at Baseline as log10 copies/milliliter (mL).
Number of participants with Baseline plasma HIV-1 RNA <=100000 copies/mL and >100000 copies/mL   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants
<=100000 copies/mL 8
>100000 copies/mL 5
[1]
Measure Description: The number of participants with Baseline plasma HIV-1 RNA <= 100000 copies/mL and >100000 copies/mL was measured.
1.Primary Outcome
Title The Ratio of Total and Unbound DTG Concentrations Between Cerebrospinal Fluid (CSF) and Plasma at Week 2 and Week 16
Hide Description Cerebrospinal fluid (CSF) is a clear, colorless bodily fluid produced in the choroid plexus of the brain. The CFS samples were collected at the Week 2 and Week 16 visits, within 1 hour of plasma pharmacokinetic (PK) sampling. The ratio (presented as a percentage) of CSF DTG concentration over paired plasma total DTG concentration (RCSF_plasma) was calculated at the Week 2 and Week 16 visits.
Time Frame Week 2 and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Plasma/CSF DTG Paired Sample Population: participants (par.) with plasma and CSF samples collected post-dose and within 1 hour of each other (one par. withdrew prior to Week 2 and did not contribute to PK assessments). One par. was excluded from the analysis at Week 2 because his/her paired samples were not collected within the specified timeframe.
Arm/Group Title Dolutegravir 50 mg OD
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
Overall Number of Participants Analyzed 12
Median (Full Range)
Unit of Measure: percentage
Week 2, n=11
0.516
(0.115 to 0.658)
Week 16, n=12
0.412
(0.299 to 2.04)
2.Primary Outcome
Title Total DTG Plasma Concentrations at Week 2 and Week 16
Hide Description Total plasma DTG concentrations were calculated at the Week 2 and Week 16 visits.
Time Frame Week 2 and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Plasma DTG Concentration Population: all participants receiving DTG who underwent PK sampling during the study and provided evaluable DTG plasma concentration data
Arm/Group Title Dolutegravir 50 mg OD
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
Overall Number of Participants Analyzed 12
Median (Full Range)
Unit of Measure: Micrograms per milliliter (µg/mL)
Week 2
3.36
(2.09 to 5.28)
Week 16
3.21
(0.64 to 4.92)
3.Primary Outcome
Title Unbound DTG Plasma Concentrations at Week 2 and Week 16
Hide Description Unbound (free, not bound to cellular proteins) plasma DTG concentrations were calculated at the Week 2 and Week 16 visits.
Time Frame Week 2 and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Plasma DTG Concentration Population
Arm/Group Title Dolutegravir 50 mg OD
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
Overall Number of Participants Analyzed 12
Median (Full Range)
Unit of Measure: Nanograms per milliliter (ng/mL)
Week 2
17.1
(10.3 to 24.0)
Week 16
23.9
(3.81 to 32.1)
4.Primary Outcome
Title Plasma DTG Unbound Fraction at Week 2 and Week 16
Hide Description The unbound fraction of DTG in plasma (presented as a percentage of unbound [i.e., free DTG not bound to cellular proteins] DTG plasma concentration over paired plasma total DTG concentration) was calculated at the Week 2 and Week 16 visits.
Time Frame Week 2 and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Plasma DTG Concentration Population
Arm/Group Title Dolutegravir 50 mg OD
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
Overall Number of Participants Analyzed 12
Median (Full Range)
Unit of Measure: Percentage
Week 2
0.488
(0.333 to 0.655)
Week 16
0.701
(0.488 to 4.30)
5.Primary Outcome
Title DTG Concentrations in CSF at Weeks 2 and Week 16
Hide Description CSF is a clear, colorless bodily fluid produced in the choroid plexus of the brain. The CFS samples were collected at the Week 2 and Week 16 visits, within 1 hour of plasma PK sampling. DTG concentration in CSF were calculated at the Week 2 and Week 16 visits.
Time Frame Week 2 and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
CSF DTG Concentration Population: all participants receiving DTG who underwent lumbar puncture during the study and provided evaluable DTG CSF concentration data. One participant was excluded from the analysis at Week 2.
Arm/Group Title Dolutegravir 50 mg OD
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
Overall Number of Participants Analyzed 12
Median (Full Range)
Unit of Measure: Nanograms per milliliter (ng/mL)
Week 2, n=11
18.2
(4.0 to 23.2)
Week 16, n=12
13.2
(3.7 to 18.3)
6.Secondary Outcome
Title Number of Participants With Plasma HIV-1 RNA <50 Copies Per Milliliter (c/mL) at Baseline and Weeks 2, 4, 8, 12, and 16
Hide Description HIV-1 RNA response in plasma was measured as the number of participants with HIV-1 RNA less than 50 c/mL at Baseline, Week 2, Week 4, Week 8, Week 12, and Week 16.
Time Frame Baseline; Weeks 2, 4, 8, 12, and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Intent -to-Treat Exposed (ITT-E) Population: all participants who received at least one dose of investigational product
Arm/Group Title Dolutegravir 50 mg OD
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: participants
Baseline 0
Week 2 4
Week 4 6
Week 8 8
Week 12 10
Week 16 10
7.Secondary Outcome
Title Absolute Values and Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) Levels at Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Hide Description The plasma samples were collected at the Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, and Week 96 visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline; Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Only those participants available at the indicated time point were assessed.
Arm/Group Title Dolutegravir 50 mg OD
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
Overall Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: log10 copies/mL
Absolute value, Baseline, n=13
4.73
(3.60 to 6.57)
Absolute value, Week 2, n=12
2.05
(1.59 to 2.99)
Change from Baseline, Week 2, n=12
-2.53
(-3.70 to -2.01)
Absolute value, Week 4, n=12
1.67
(1.59 to 2.49)
Change from Baseline, Week 4, n=12
-3.04
(-4.08 to -2.01)
Absolute Value, Week 8, n=12
1.59
(1.59 to 2.48)
Change from Baseline, Week 8, n=12
-3.10
(-4.09 to -2.01)
Absolute value, Week 12, n=12
1.59
(1.59 to 2.36)
Change from Baseline, Week 12, n=12
-3.04
(-4.20 to -2.01)
Absolute value, Week 16, n=12
1.59
(1.59 to 2.37)
Change from Baseline, Week 16, n=12
-3.04
(-4.19 to -2.01)
Absolute Value, Week 24, n=12
1.59
(1.59 to 2.21)
Change from Baseline, Week 24, n=12
-3.11
(-4.35 to -2.01)
Absolute value, Week 36, n=11
1.59
(1.59 to 1.62)
Change from Baseline, Week 36, n=11
-3.08
(-3.89 to -2.01)
Absolute value, Week 48, n=11
1.59
(1.59 to 2.10)
Change from Baseline, Week 48, n=11
-3.00
(-3.78 to -2.01)
Absolute value, Week 60, n=11
1.59
(1.59 to 2.19)
Change from Baseline, Week 60, n=11
-3.00
(-3.89 to -2.01)
Absolute value, Week 72, n=11
1.59
(1.59 to 2.01)
Change from Baseline, Week 72, n=11
-3.08
(-3.78 to -2.01)
Absolute value, Week 84, n=11
1.59
(1.59 to 1.72)
Change from Baseline, Week 84, n=11
-3.08
(-3.89 to -1.88)
Absolute value, Week 96, n=11
1.59
(1.59 to 3.05)
Change from Baseline, Week 96, n=11
-3.08
(-3.78 to -0.55)
8.Secondary Outcome
Title Number of Participants With CSF HIV-1 RNA <50 Copies/Milliliter (c/mL) at Baseline, Week 2, and Week 16
Hide Description The antiviral activity of dolutegravir in CSF over time was measured as the number of participants with HIV-1 RNA <50 copies/milliliter (c/mL).
Time Frame Baseline, Week 2, and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
CSF Pharmacodynamic Population: all participants who received DTG and underwent lumbar puncture during the study and provided CSF HIV-1 RNA data. Only those participants available at the indicated time points were assessed.
Arm/Group Title Dolutegravir 50 mg OD
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: participants
Baseline, n=13 1
Week 2, n=12 7
Week 16, n=11 11
9.Secondary Outcome
Title Absolute Values and Change From Baseline in CSF HIV-1 RNA Levels at Week 2 and Week 16
Hide Description The antiviral activity of dolutegravir in CSF over time was measured as absolute values and change from Baseline in HIV-1 RNA levels in CSF at Week 2 and Week 16. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline, Week 2, and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
CSF Pharmacodynamic Population. Only those participants available at the indicated time points were assessed.
Arm/Group Title Dolutegravir 50 mg OD
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
Overall Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: log10 c/mL
Absolute value, Baseline, n=13
3.64
(1.46 to 5.60)
Absolute value, Week 2, n=12
0.98
(0.00 to 3.30)
Change from Baseline, Week 2, n=12
-2.19
(-3.11 to -1.29)
Absolute value, Week 16, n=11
0.00
(0.00 to 0.70)
Change from Baseline, Week 16, n=11
-3.42
(-5.60 to -1.46)
10.Secondary Outcome
Title Number of Participants With the Indicated Number of Copies of HIV-1 RNA in Both the CSF and Plasma at Baseline, Week 2, and Week 16
Hide Description The relationship between HIV-1 RNA suppression in plasma and the CSF was measured as a comparison and as a change in the number of participants in the cross tabulation of <50 copies/mL in plasma, <50 copies/mL in CSF, >=50 copies/mL in plasma, and >=50 copies/mL in CSF at Baseline, Week 2, and Week 16.
Time Frame Baseline, Week 2, and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
CSF Pharmacodynamic Population. Only those participants available at the indicated time point were assessed.
Arm/Group Title Dolutegravir 50 mg OD
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: participants
Baseline, CSF<50 c/mL, Plasma<50 c/mL, n=13 0
Baseline, CSF<50 c/mL, Plasma>=50 c/mL, n=13 1
Baseline, CSF>=50 c/mL, Plasma<50 c/mL, n=13 0
Baseline, CSF>=50 c/mL, Plasma>=50 c/mL, n=13 12
Week 2, CSF<50 c/mL, Plasma<50 c/mL, n=12 4
Week 2, CSF<50 c/mL, Plasma>=50 c/mL, n=12 3
Week 2, CSF>=50 c/mL, Plasma<50 c/mL, n=12 0
Week 2, CSF>=50 c/mL, Plasma>=50 c/mL, n=12 5
Week 16, CSF<50 c/mL, Plasma<50 c/mL, n=11 9
Week 16, CSF<50 c/mL, Plasma>=50 c/mL, n=11 2
Week 16, CSF>=50 c/mL, Plasma<50 c/mL, n=11 0
Week 16, CSF>=50 c/mL, Plasma>=50 c/mL, n=11 0
11.Secondary Outcome
Title Pearson Correlation Between CSF DTG Concentration and Absolute Values and Change From Baseline (CFB) in CSF HIV-1 RNA at Week 2, Week 16, and Overall
Hide Description The Pearson Correlation Coefficient is a measure of the correlation between CSF DTG concentrations and absolute values/changes from Baseline in CSF HIV-1 RNA at Week 2 and Week 16. CSF HIV-1 RNA is measured as log10 copies per milliliter (copies/mL).
Time Frame From Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
CSF Pharmacodynamic Population. The overall analysis combines Week 2 and Week 16 data; thus, analysis was performed on 22 data points from 11 participants.
Arm/Group Title Dolutegravir 50 mg OD
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
Overall Number of Participants Analyzed 11
Mean (90% Confidence Interval)
Unit of Measure: Pearson Correlation Coefficient
Week 2, Absolute Log10 CSF HIV-1 RNA, n=11
0.567
(0.062 to 0.841)
Week 2, CFB Log10 CSF HIV-1, n=11
0.007
(-0.518 to 0.529)
Week 16, Absolute Log10 CSF HIV-1 RNA, n=11
-0.775
(-0.924 to -0.423)
Week 16, CFB Log10 CSF HIV-1, n=11
-0.354
(-0.740 to 0.209)
Overall, Absolute Log10 CSF HIV-1 RNA, n=11
0.517
(0.193 to 0.740)
Overall, CFB Log10 CSF HIV-1, n=11
0.106
(-0.265 to 0.449)
12.Secondary Outcome
Title Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Hide Description The absolute value for CD4+ cell count (cells per millimeters cubed [mm^3]) was assessed at Baseline, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, and Week 96. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline; Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Only those participants available at the indicated time point were assessed.
Arm/Group Title Dolutegravir 50 mg OD
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
Overall Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: cells/mm^3
Absolute CD4+ cell count, Baseline, n=13
260
(152 to 863)
Absolute CD4+ cell count, Week 4, n=12
578
(374 to 903)
Absolute CD4+ cell count, Week 8, n=12
645
(364 to 1118)
Absolute CD4+ cell count, Week 12, n=12
589
(303 to 1144)
Absolute CD4+ cell count, Week 16, n=12
573
(436 to 1156)
Absolute CD4+ cell count, Week 24, n=12
634
(448 to 1339)
Absolute CD4+ cell count, Week (Wk) 36, n=11
706
(534 to 1351)
Absolute CD4+ cell count, Week 48, n=11
666
(537 to 939)
Absolute CD4+ cell count, Week 60, n=11
702
(567 to 1266)
Absolute CD4+ cell count, Week 72, n=11
823
(620 to 1315)
Absolute CD4+ cell count, Week 84, n=11
907
(512 to 1341)
Absolute CD4+ cell count, Week 96, n=11
843
(339 to 1436)
Change from Baseline CD4+ cell count, Week 4, n=12
162
(-158 to 365)
Change from Baseline CD4+ cell count, Week 8, n=12
247
(44 to 551)
Change from Baseline CD4+ cell count, Wk 12, n=12
263
(-17 to 500)
Change from Baseline CD4+ cell count, Wk 16, n=12
226
(-248 to 629)
Change from Baseline CD4+ cell count, Wk 24, n=12
264
(86 to 762)
Change from Baseline CD4+ cell count, Wk 36, n=11
480
(174 to 774)
Change from Baseline CD4+ cell count, Wk 48, n=11
311
(-80 to 541)
Change from Baseline CD4+ cell count, Wk 60, n=11
382
(5 to 708)
Change from Baseline CD4+ cell count, Wk 72, n=11
519
(260 to 651)
Change from Baseline CD4+ cell count, Wk 84, n=11
543
(94 to 792)
Change from Baseline CD4+ cell count, Wk 96, n=11
467
(-65 to 859)
13.Secondary Outcome
Title Absolute Values and Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at Weeks 4, 12, 16, 24, 48, and 96
Hide Description The absolute value for CD48+ cell count (cells per millimeters cubed [mm^3]) was assessed at Baseline, Week 4, Week 12, Week 16, Week 24, Week 48, and Week 96. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline; Weeks 4, 12, 16, 24, 48, and 96
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Only those participants available at the indicated time point were assessed.
Arm/Group Title Dolutegravir 50 mg OD
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
Overall Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: cells/mm^3
Absolute CD8+ cell count, Baseline, n=13
757
(276 to 2945)
Absolute CD8+ cell count, Week 4, n=12
874
(542 to 1984)
Absolute CD8+ cell count, Week 12, n=12
865
(419 to 1472)
Absolute CD8+ cell count, Week 16, n=12
706
(478 to 1818)
Absolute CD8+ cell count, Week 24, n=11
876
(434 to 1634)
Absolute CD8+ cell count, Week 48, n=11
708
(530 to 1318)
Absolute CD8+ cell count, Week 96, n=11
842
(249 to 1582)
Change from Baseline CD8+ cell count, Week 4, n=12
104
(-1123 to 1060)
Change from Baseline CD8+ cell count,Week 12, n=11
-53
(-1627 to 631)
Change from Baseline CD8+ cell count,Week 16, n=11
-35
(-1614 to 684)
Change from Baseline CD8+ cell count,Week 24, n=11
235
(-418 to 710)
Change from Baseline CD8+ cell count,Week 48, n=11
106
(-747 to 441)
Change from Baseline CD8+ cell count,Week 96, n=11
85
(-424 to 677)
14.Secondary Outcome
Title Number of Participants With Post-Baseline HIV-1-associated Conditions, Including Recurrences
Hide Description The number of participants who reported a new or recurrent Centers for Disease Control and Prevention (CDC) Class B or Class C condition was assessed from Baseline though the date the last participant completed Week 96 + the follow-up visit (if applicable). Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition.
Time Frame Baseline through the date the last participant completed Week 96 + follow-up visit (if applicable)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title Dolutegravir 50 mg OD
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: participants
New CDC Category B event 0
Recurring CDC Category B event 0
New CDC Category C event 0
Recurring CDC Category C event 0
15.Secondary Outcome
Title The Numbers of Participants (Par.) With Clinical Adverse Events or Laboratory Abnormalities
Hide Description An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs/SAEs. Any abnormal laboratory test result (hematology, clinical chemistry, or urinalysis) or other safety assessments (e.g., electrocardiograms [ECGs], radiological scans, vital sign measurements), including those that worsen from Baseline, and were felt to be clinically significant in the medical and scientific judgment of the investigator, were recorded as AEs or SAEs. Clinically suspected cases of hypersensitivity to ABC were also SAEs.
Time Frame Baseline (BL) through the date the last participant completed Week (W) 96 + the follow-up visit (if applicable)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least one dose of study medication. Participants were analyzed according to the actual treatments received. Participants were not excluded from this population as a result of changes to the background regimen.
Arm/Group Title Dolutegravir 50 mg OD
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: participants
Any AE 13
Clinical chemistry toxicities 12
Hematology toxicities 3
Abnormal ECG (clinically significant) 0
16.Secondary Outcome
Title Number of Participants With Treatment-emergent Genotypic and Phenotypic Resistance to DTG and Other Antiretroviral Therapy (ART)
Hide Description The number of participants with treatment-emergent genotypic and phenotypic resistance to integrase inhibitors (INIs), nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transctiptase inhibitors (NNRTIs), and protease inhibitors (PIs) was assessed.
Time Frame Baseline through the date the last participant completed Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Protocol Defined Virologic Failure (PDVF) Genotypic Population (Integrase inhibitor [IN] Results at Baseline and PDVF): The PDVF Genotypic and Phenotypic populations consisted of all participants in the ITT-E Population with available on-treatment genotypic and phenotypic resistance data, respectively, at the time of PDVF
Arm/Group Title Dolutegravir 50 mg OD
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: participants
Treatment-emergent genotypic resistance 0
Treatment-emergent phenotypic resistance 0
Time Frame Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the date the last participant completed Week 96+ follow-up visit (if applicable).
Adverse Event Reporting Description SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
 
Arm/Group Title Dolutegravir 50 mg OD
Hide Arm/Group Description Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
All-Cause Mortality
Dolutegravir 50 mg OD
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Dolutegravir 50 mg OD
Affected / at Risk (%)
Total   2/13 (15.38%) 
Hepatobiliary disorders   
Cholecystitis  1  1/13 (7.69%) 
Infections and infestations   
Pharyngitis  1  1/13 (7.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dolutegravir 50 mg OD
Affected / at Risk (%)
Total   13/13 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  1  1/13 (7.69%) 
Increased tendency to bruise  1  1/13 (7.69%) 
Eye disorders   
Eye pruritus  1  1/13 (7.69%) 
Gastrointestinal disorders   
Diarrhoea  1  4/13 (30.77%) 
Nausea  1  2/13 (15.38%) 
Abdominal distension  1  1/13 (7.69%) 
Constipation  1  1/13 (7.69%) 
Dyspepsia  1  1/13 (7.69%) 
Food poisoning  1  2/13 (15.38%) 
Gastrooesophageal reflux disease  1  1/13 (7.69%) 
Haemorrhoids  1  3/13 (23.08%) 
General disorders   
Fatigue  1  3/13 (23.08%) 
Hunger  1  1/13 (7.69%) 
Impaired healing  1  1/13 (7.69%) 
Infections and infestations   
Folliculitis  1  2/13 (15.38%) 
Pharyngitis  1  2/13 (15.38%) 
Upper respiratory tract infection  1  5/13 (38.46%) 
Anal chlamydia infection  1  1/13 (7.69%) 
Influenza  1  2/13 (15.38%) 
Oral herpes  1  2/13 (15.38%) 
Otitis externa  1  1/13 (7.69%) 
Syphilis  1  1/13 (7.69%) 
Tooth abscess  1  1/13 (7.69%) 
Acarodermatitis  1  2/13 (15.38%) 
Conjunctivitis  1  2/13 (15.38%) 
Herpes simplex  1  2/13 (15.38%) 
Oropharyngeal gonococcal infection  1  2/13 (15.38%) 
Body tinea  1  1/13 (7.69%) 
Bronchitis  1  1/13 (7.69%) 
Chlamydial infection  1  1/13 (7.69%) 
Gonorrhoea  1  1/13 (7.69%) 
Otitis media  1  1/13 (7.69%) 
Sinusitis  1  1/13 (7.69%) 
Injury, poisoning and procedural complications   
Procedural pain  1  3/13 (23.08%) 
Excoriation  1  1/13 (7.69%) 
Investigations   
Weight increased  1  1/13 (7.69%) 
Lipase increased  1  1/13 (7.69%) 
Metabolism and nutrition disorders   
Decreased appetite  1  1/13 (7.69%) 
Hyperlipidaemia  1  1/13 (7.69%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  1/13 (7.69%) 
Pain in jaw  1  1/13 (7.69%) 
Musculoskeletal pain  1  3/13 (23.08%) 
Myalgia  1  1/13 (7.69%) 
Myositis  1  1/13 (7.69%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Skin papilloma  1  1/13 (7.69%) 
Nervous system disorders   
Headache  1  7/13 (53.85%) 
Carpal tunnel syndrome  1  1/13 (7.69%) 
Paraesthesia  1  1/13 (7.69%) 
Sciatica  1  1/13 (7.69%) 
Psychiatric disorders   
Depression  1  1/13 (7.69%) 
Sleep disorder  1  1/13 (7.69%) 
Emotional disorder  1  1/13 (7.69%) 
Insomnia  1  1/13 (7.69%) 
Libido decreased  1  1/13 (7.69%) 
Renal and urinary disorders   
Pollakiuria  1  1/13 (7.69%) 
Urine flow decreased  1  1/13 (7.69%) 
Reproductive system and breast disorders   
Gynaecomastia  1  1/13 (7.69%) 
Prostatitis  1  2/13 (15.38%) 
Respiratory, thoracic and mediastinal disorders   
Sinus congestion  1  2/13 (15.38%) 
Rhinitis allergic  1  3/13 (23.08%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  1/13 (7.69%) 
Dermatitis  1  1/13 (7.69%) 
Eczema  1  1/13 (7.69%) 
Seborrhoeic dermatitis  1  1/13 (7.69%) 
Rash  1  1/13 (7.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications:
Letendre S, Mills A, Tashima K, et al. Distribution and antiviral activity in cerebrospinal fluid (CSF) of the integrase inhibitor, dolutegravir (DTG): ING116070 week 16 results. Published at: Conference on Retroviruses and Opportunistic Infections - 20th Annual; March 3-6, 2013; Atlanta, GA.
Letendre S, Mills A, Tashima K, et al. CSF penetration and antiviral activity of the integrase inhibitor, dolutegravir (DTG, GSK1349572): ING116070 week 16 results. Published at: International Symposium on Neuropsychiatry & HIV - 6th; May 9-10, 2013; Barcelona, Spain
Layout table for additonal information
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01499199    
Other Study ID Numbers: 116070
First Submitted: December 15, 2011
First Posted: December 26, 2011
Results First Submitted: August 15, 2013
Results First Posted: November 25, 2013
Last Update Posted: February 25, 2015