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A Pilot Study Assessing the Integrase Inhibitor GSK1349572 in HIV-infected Persons With Virus Resistant to Raltegravir

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ClinicalTrials.gov Identifier: NCT00950859
Recruitment Status : Completed
First Posted : August 3, 2009
Results First Posted : October 21, 2013
Last Update Posted : December 4, 2015
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Infection, Human Immunodeficiency Virus
Interventions Drug: GSK1349572 (Cohort I)
Drug: GSK1349572 (Cohort II)
Enrollment 51

Recruitment Details Participants recruited initially to Cohort I and subsequently to Cohort II. Recruitment to Cohort I was closed 9 months before recruitment to Cohort II was opened. Recruitment was not randomized.
Pre-assignment Details  
Arm/Group Title Cohort I (DTG 50 mg OD) Cohort II (DTG 50 mg BID)
Hide Arm/Group Description Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD). Participants received DTG 50 mg twice a day (BID).
Period Title: Overall Study
Started 27 24
Completed 11 14
Not Completed 16 10
Reason Not Completed
Adverse Event             3             3
Insufficient Viral Load Response             12             3
Protocol Violation             1             1
Lost to Follow-up             0             3
Arm/Group Title Cohort I (DTG 50 mg OD) Cohort II (DTG 50 mg BID) Total
Hide Arm/Group Description Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD). Participants received DTG 50 mg twice a day (BID). Total of all reporting groups
Overall Number of Baseline Participants 27 24 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Years Number Analyzed 27 participants 24 participants 51 participants
48
(19 to 61)
47
(33 to 68)
47
(19 to 68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 24 participants 51 participants
Female
2
   7.4%
6
  25.0%
8
  15.7%
Male
25
  92.6%
18
  75.0%
43
  84.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants 24 participants 51 participants
African American/African Heritage 3 5 8
White-Arabic/North African Heritage 1 1 2
White-White/Caucasian/European Heritage 23 18 41
1.Primary Outcome
Title Number of Participants Who Achieved HIV-1 RNA <400 Copies (c)/Milliliter (mL) or at Least 0.7 log10 c/mL Below Their Baseline Value at Day 11
Hide Description The number of participants who acheived Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <400 c/mL or at least 0.7 log10 c/mL below their Baseline value at Day 11 was assessed. The last observation was carried forward if a participant had missed the Day 11 visit. The Baseline observation was carried forward if a participant had discontinued the treatment before Day 11. Blood samples for assessment of HIV-1 RNA levels were collected at Baseline and Day 11.
Time Frame Baseline (Day 1) and Day 11
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Exposed (ITT-E) Population: all participants who received at least one dose of study medication and who had at least one post-Baseline measure of plasma HIV-1 RNA.
Arm/Group Title Cohort I (DTG 50 mg OD) Cohort II (DTG 50 mg BID)
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
Participants received DTG 50 mg twice a day (BID).
Overall Number of Participants Analyzed 27 24
Measure Type: Number
Unit of Measure: Participants
21 23
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort I (DTG 50 mg OD)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of participants
Estimated Value 78
Confidence Interval (2-Sided) 95%
58 to 91
Estimation Comments The estimated value represents the percentage of participants with HIV-1 RNA <400 c/mL or at least 0.7 log10 c/mL below their Baseline value at Day 11.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort II (DTG 50 mg BID)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of participants
Estimated Value 96
Confidence Interval 95%
79 to 100
Estimation Comments The estimated value represents the percentage of participants with HIV-1 RNA <400 c/mL or at least 0.7 log10 c/mL below their Baseline value at Day 11.
2.Secondary Outcome
Title Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion
Hide Description Mean change from Baseline in Plasma HIV-1 RNA was assessed on Day 6 to 8, Day 11, and Weeks 4, 12, 24, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, and 264 using data of the observed cases. Study Day 1 was considered as Baseline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline; Day 6 to 8; Day 11; Weeks 4, 12, 24, 48, 72, 96, from 108 every 12 weeks up to study completion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Only those participants available at the indicated time points were analyzed (represented by n=X, X in the category titles).
Arm/Group Title Cohort I (DTG 50 mg OD) Cohort II (DTG 50 mg BID)
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
Participants received DTG 50 mg twice a day (BID).
Overall Number of Participants Analyzed 27 24
Mean (Standard Deviation)
Unit of Measure: Log10 copies/mL
Day 6 to 8, n=27, 24 -1.31  (0.71) -1.40  (0.43)
Day 11, n=27, 24 -1.45  (0.77) -1.76  (0.53)
Week 4, n=26, 24 -1.82  (1.03) -2.06  (0.78)
Week 12, n=22, 24 -1.94  (1.14) -2.30  (0.93)
Week 24, n=18, 22 -1.99  (1.08) -2.50  (0.81)
Week 48, n=15, 20 -2.02  (1.07) -2.63  (0.78)
Week 72, n=14, 18 -2.10  (1.03) -2.71  (0.82)
Week 96, n=13, 15 -2.06  (1.13) -2.58  (0.77)
Week 108, n= 13, 17 -1.95  (1.20) -2.69  (0.82)
Week 120, n= 11, 17 -2.09  (1.15) -2.67  (0.85)
Week 132, n= 11, 17 -1.83  (1.01) -2.66  (0.86)
Week 144, n= 12, 15 -2.08  (1.29) -2.62  (0.94)
Week 156, n= 12, 15 -2.04  (1.36) -2.65  (0.77)
Week 168, n= 11, 14 -1.77  (1.26) -2.72  (0.89)
Week 180, n= 11, 10 -1.76  (1.11) -2.56  (0.82)
Week 192, n= 9, 7 -1.87  (1.16) -2.51  (0.98)
Week 204, n= 10, 6 -1.76  (1.21) -2.35  (0.71)
Week 216, n= 9, 6 -1.61  (1.08) -2.35  (0.71)
Week 228, n= 6, 4 -1.79  (1.08) -2.33  (0.90)
Week 240, n= 7, 0 -1.63  (1.13) NA [1]   (NA)
Week 252, n= 4, 0 -1.72  (1.07) NA [1]   (NA)
Week 264, n= 1, 0 -2.90 [2]   (NA) NA [1]   (NA)
[1]
Since 0 participants were analyzed, no data to present.
[2]
As only 1 participant was analyzed; therefore, no SD to present.
3.Secondary Outcome
Title Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.
Hide Description The number of participants with plasma HIV-1 RNA <400 c/mL or <50 c/mL was assessed at Weeks 4, 12, 24, 48, 72, and 96 per the Food and Drug Administration's Time to Loss of Virological Response (TLOVR) algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason.
Time Frame Baseline; Weeks 4, 12, 24, 48, 72, and 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title Cohort I (DTG 50 mg OD) Cohort II (DTG 50 mg BID)
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
Participants received DTG 50 mg twice a day (BID).
Overall Number of Participants Analyzed 27 24
Measure Type: Number
Unit of Measure: Participants
Baseline, <50 c/mL 0 0
Week 4, <50 c/mL 9 12
Week 12, <50 c/mL 13 16
Week 24, <50 c/mL 11 19
Week 48, <50 c/mL 9 17
Week 72, <50 c/mL 8 NA [1] 
Week 96, <50 c/mL 7 NA [1] 
Baseline, <400 c/mL 0 0
Week 4, <400 c/mL 16 17
Week 12, <400 c/mL 16 20
Week 24, <400 c/mL 14 20
Week 48, <400 c/mL 13 18
Week 72, <400 c/mL 12 NA [2] 
Week 96, <400 c/mL 10 NA [2] 
[1]
As of the data cut-off, Week 48 is the last time point which all participants in Cohort II would have had opportunity to reach if they had not discontinued prematurely. Only data to Week 48 were therefore analyzed using TLOVR.
[2]
As of the data cut-off, Week 48 is the last time point which all participants in Cohort II would have had opportunity to reach if they had not discontinued prematurely. Only data to Week 48 were therefore analysed using TLOVR.
4.Secondary Outcome
Title Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion
Hide Description The number of participants with plasma HIV-1 RNA <400 c/mL or <50 c/mL was assessed at Weeks 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, and 264 using data of observed cases. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame From Week 48 every 12 weeks up to study completion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title Cohort I (DTG 50 mg OD) Cohort II (DTG 50 mg BID)
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
Participants received DTG 50 mg twice a day (BID).
Overall Number of Participants Analyzed 27 24
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 48, <50 c/mL, n=15, 20 60 80
Week 60, <50 c/mL, n=13, 18 69 94
Week 72, <50 c/mL, n=14, 18 64 78
Week 84, <50 c/mL, n=14, 18 57 78
Week 96, <50 c/mL, n=13, 15 54 87
Week 108, <50 c/mL, n=13, 17 54 88
Week 120, <50 c/mL, n=11, 17 55 88
Week 132, <50 c/mL, n=11, 17 55 82
Week 144, <50 c/mL, n=12, 15 58 87
Week 156, <50 c/mL, n=12, 15 67 93
Week 168, <50 c/mL, n=11, 14 64 86
Week 180, <50 c/mL, n=11, 10 64 100
Week 192, <50 c/mL, n= 9, 7 67 100
Week 204, <50 c/mL, n= 10, 6 50 100
Week 216, <50 c/mL, n= 9, 6 56 100
Week 228, <50 c/mL, n=6, 4 67 100
Week 240, <50 c/mL, n=7,0 57 NA [1] 
Week 252, <50 c/mL, n=4, 0 50 NA [1] 
Week 264, <50 c/mL, n=1, 0 100 NA [1] 
Week 48, <400 c/mL, n=15, 20 73 95
Week 60,<400 c/mL, n=13, 18 92 100
Week 72,<400 c/mL, n=14, 18 79 100
Week 84,<400 c/mL, n=14, 18 71 94
Week 96,<400 c/mL, n=13, 15 85 100
Week 108,<400 c/mL, n=13,17 85 100
Week 120,<400 c/mL, n=11, 17 82 94
Week 132,<400 c/mL, n=11,17 82 94
Week 144,<400 c/mL, n=12, 15 83 93
Week 156,<400 c/mL, n=12, 15 75 100
Week 168,<400 c/mL, n=11, 14 82 100
Week 180,<400 c/mL, n=11, 10 73 100
Week 192,<400 c/mL, n=9, 7 78 100
Week 204,<400 c/mL, n=10, 6 70 100
Week 216,<400 c/mL, n=9, 6 56 100
Week 228,<400 c/mL, n=6, 4 67 100
Week 240,<400 c/mL, n=7, 0 71 NA [1] 
Week 252,<400 c/mL, n=4, 0 50 NA [1] 
Week 264,<400 c/mL, n=1, 0 100 NA [1] 
[1]
Since 0 participants were analyzed, no value to present.
5.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion
Hide Description Change from Baseline in CD4+ cell count was assessed at Day 11 and at Weeks 4, 12, 24, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, and 264 . Study Day 1 was considered as Baseline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time Frame Baseline; Day 11; Weeks 4, 12, 24, 48, 72, 96, from Week 108 every 12 weeks up to study completion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Only those participants available at the indicated time points were analyzed (represented by n=X in the category titles).
Arm/Group Title Cohort I (DTG 50 mg OD) Cohort II (DTG 50 mg BID)
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
Participants received DTG 50 mg twice a day (BID).
Overall Number of Participants Analyzed 27 24
Median (Full Range)
Unit of Measure: cells per cubic millimeter (mm^3)
Baseline, n=27, 24
114
(44 to 227)
202
(19 to 384)
Day 11, n=27, 24
34
(2 to 71)
14
(0 to 69)
Week 4, n=27, 24
57
(33 to 108)
35
(8 to 69)
Week 12, n= 22, 24
84
(26 to 124)
57
(8 to 103)
Week 24, n=17, 22
78
(54 to 175)
79
(17 to 147)
Week 48, n=15, 20
102
(29 to 160)
106
(45 to 245)
Week 72, n=14, 18
163
(58 to 204)
191.5
(80 to 277)
Week 96, n=13, 15
142
(75 to 202)
189
(75 to 280)
Week 108, n=13, 17
124
(68 to 249)
155
(91 to 276)
Week 120, n=11, 17
221
(62 to 306)
221
(135 to 314)
Week 132, n=11, 17
97
(26 to 303)
158
(129 to 384)
Week 144, n=12, 15
121
(28 to 284)
278
(113 to 340)
Week 156, n=12, 15
212
(64 to 378)
223
(131 to 309)
Week 168, n=11, 13
97
(-102 to 365)
271
(93 to 357)
Week 180, n=11, 10
125
(55 to 327)
224
(163 to 288)
Week 192, n=10, 7
94
(61 to 291)
343
(304 to 429)
Week 204, n=10, 6
92
(47 to 364)
264
(186 to 370)
Week 216, n=9, 6
172
(48 to 416)
252
(147 to 421)
Week 228, n=7, 3
148
(66 to 357)
417
(-12 to 633)
Week 240, n=7, 0
158
(119 to 470)
NA [1] 
(NA to NA)
Week 252, n=4, 0
157
(109 to 282)
NA [1] 
(NA to NA)
Week 264, n=1, 0
560
(560 to 560)
NA [1] 
(NA to NA)
[1]
Since 0 participants were analyzed, no data to present.
6.Secondary Outcome
Title Cmax, Cmin, and Ctau of DTG
Hide Description The maximum plasma concentration (Cmax), minimum plasma concentration (Cmin), and concentration at the end of a dosing interval (Ctau) of DTG were assessed at Day 10. Blood samples for pharmacokinetic (PK) assessments were collected at pre-dose (within 15 minutes prior to dose) and 2, 3, 4, 8, and 24 hours post-dose on Day 10 for DTG 50 mg OD and pre-dose (within 15 minutes prior to dose) and 2, 3, 4 and 8 hours post morning dose and 12 hours post evening dose for DTG 50 mg BID.
Time Frame Day 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) Parameter Population: all participants who provided at least one evaluable PK concentration
Arm/Group Title Cohort I (DTG 50 mg OD) Cohort II (DTG 50 mg BID)
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
Participants received DTG 50 mg twice a day (BID).
Overall Number of Participants Analyzed 25 23
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms per milliliter (µg/mL)
Cmax
3.04
(38%)
5.41
(40%)
Ctau
0.69
(91%)
2.72
(70%)
Cmin
0.48
(136%)
2.61
(67%)
7.Secondary Outcome
Title C0 Assessment of DTG
Hide Description The plasma DTG concentration immediately prior to dosing at steady state (C0) was assessed at Day 10, and Weeks 4 and 24. Blood samples for pharmacokinetic assessments were collected at pre-dose (within 15 minutes prior to dose).
Time Frame Day 10; Weeks 4 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
Arm/Group Title Cohort I (DTG 50 mg OD) Cohort II (DTG 50 mg BID)
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
Participants received DTG 50 mg twice a day (BID).
Overall Number of Participants Analyzed 25 23
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
C0, Day 10
0.51
(139%)
3.20
(69%)
C0, Week 4
0.57
(100%)
2.55
(63%)
C0, Week 24
0.38
(114%)
2.38
(69%)
8.Secondary Outcome
Title Tmax of DTG
Hide Description The tmax is defined as the time of occurrence of the maximum plasma concentration (Cmax). The tmax was assessed at Day 10. Blood samples for pharmacokinetic assessments were collected at pre-dose (within 15 minutes prior to dose) and 2, 3, 4, 8, and 24 hours post-dose on Day 10 for DTG 50 mg OD and pre-dose (within 15 minutes prior to dose) and 2, 3, 4 and 8 hours post morning dose and 12 hours post evening dose for DTG 50 mg BID.
Time Frame Day 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
Arm/Group Title Cohort I (DTG 50 mg OD) Cohort II (DTG 50 mg BID)
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
Participants received DTG 50 mg twice a day (BID).
Overall Number of Participants Analyzed 25 23
Median (Full Range)
Unit of Measure: Hours
2.97
(1.97 to 7.92)
2.00
(0.00 to 7.87)
9.Secondary Outcome
Title AUC0-24 Assessment of DTG
Hide Description AUC is defined as the area under the DTG concentration-time curve as a measure of drug exposure. AUC(0-24) is defined as the area under the concentration-time curve from time zero (pre-dose) to 24 hours. AUC0-24 of DTG was assessed at Day 10. Blood samples for pharmacokinetic assessments were collected at pre-dose (within 15 minutes prior to dose) and 2, 3, 4, 8, and 24 hours post-dose on Day 10 for DTG 50 mg OD and pre-dose (within 15 minutes prior to dose) and 2, 3, 4 and 8 hours post morning dose and 12 hours post evening dose for DTG 50 mg BID.
Time Frame Day 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Population
Arm/Group Title Cohort I (DTG 50 mg OD) Cohort II (DTG 50 mg BID)
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
Participants received DTG 50 mg twice a day (BID).
Overall Number of Participants Analyzed 25 23
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms*hour per milliliter (µg*hr/mL
36.46
(53%)
93.36
(50%)
10.Secondary Outcome
Title Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences
Hide Description The number of participants with post-Baseline emergent HIV-1 disease progression (Acquired immunodeficiency syndrome (AIDS) or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).
Time Frame From the day of the first dose of study drug until study completion (median 605 days for Cohort I, median 1181 days for Cohort II)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Participant may have more than one HIV associated condition. Each condition is counted only once per participant, regardless of recurrence.
Arm/Group Title Cohort I (DTG 50 mg OD) Cohort II (DTG 50 mg BID)
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
Participants received DTG 50 mg twice a day (BID).
Overall Number of Participants Analyzed 27 24
Measure Type: Number
Unit of Measure: Participants
Category B, Candidiasis, oropharyngeal 3 2
Category B, Hairy leukoplakia, oral 2 0
Category B, Herpes Zoster 2 0
Category C, Herpes simplex 1 0
Category C, Candidiasis, esophageal 0 1
Category C, Cytomegalovirus retinitis 0 1
Category C, Kaposi's sarcoma 1 0
Category C, Lymphoma, Burkitt's 0 1
Category C, Lymphoma, immunoblastic 1 0
Death, Brain mass 1 0
Death, Completed suicide 0 1
Death, Febrile bone marrow aplasia 1 0
Death, Immunoblastic lymphoma 1 0
Death, Acute pulmonary oedema 1 0
Death, Anaemia 0 1
Death, Haemochromatosis 0 1
Death, Hepatic fibrosis 0 1
Other: Cryptosporidiosis, acute intestinal 0 1
Other: leukoplasia of both side of the tongue 1 0
11.Secondary Outcome
Title Number of Participants With HIV-1 Associated Disease Progression With the Indicated Shifts to CDC Class C or Death
Hide Description The number of participants with HIV-1 disease progression (AIDS or death) was assessed per the CDC 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).
Time Frame From the day of the first dose of study drug until study completion (median 605 days for Cohort I, median 1181 days for Cohort II)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population.
Arm/Group Title Cohort I (DTG 50 mg OD) Cohort II (DTG 50 mg BID)
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
Participants received DTG 50 mg twice a day (BID).
Overall Number of Participants Analyzed 27 24
Measure Type: Number
Unit of Measure: Participants
From CDC class A to CDC class C 0 2
From CDC class B to CDC class C 0 2
From CDC class C to new CDC class C 1 0
From CDC Class A, B, or C to death 3 2
12.Secondary Outcome
Title Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion
Hide Description PDVF is defined in relation to Baseline plasma HIV-1 RNA levels: at Day 11, a decrease of <0.7 log10 c/mL unless <400 c/mL; at Weeks 8 to <16, a decrease of <1.0 log10 c/mL unless <400 c/mL or an increase of >= 1.0 log10 c/mL from nadir; and at or after Week 16, ≥400 c/mL. PDVF at Day 11 was based on a single plasma HIV-1 RNA evaluation and did not require confirmation. Confirmation testing was required for visits at or after Week 8. For the combination treatment phase, all HIV-1 RNA samples that meet a criterion for suspected PDVF must be confirmed by a second measurement performed at least 1 week but not more than 4 weeks apart from the date of the original sample.
Time Frame Day 11; Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, from Week 108 every 12 weeks up to study completion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title Cohort I (DTG 50 mg OD) Cohort II (DTG 50 mg BID)
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
Participants received DTG 50 mg twice a day (BID).
Overall Number of Participants Analyzed 27 24
Measure Type: Number
Unit of Measure: Participants
Day 11 6 1
Week 8 7 3
Week 12 9 3
Week 16 10 5
Week 20 10 5
Week 24 12 5
Week 32 12 5
Week 40 12 5
Week 48 13 5
Week 60 13 5
Week 72 14 6
Week 84 15 6
Week 96 16 6
Week 108 16 6
Week 120 16 6
Week 132 16 6
Week 144 16 7
Week 156 16 7
Week 168 16 7
Week 180 16 7
Week 192 16 7
Week 204 16 7
Week 216 17 7
Week 228 18 7
Week 240 18 NA [1] 
Week 252 18 NA [1] 
Week 264 18 NA [1] 
[1]
No data were available for analysis from Cohort II at the time points.
13.Secondary Outcome
Title Number of Participants With the Indicated Genotypic Resistance at Baseline
Hide Description At Baseline, the integrase genotypic results were used to document resistance to raltegravir (RAL) and for the allocation of participants to one of two genotypic groups according to their RAL signature mutations to ensure a broad range of sensitivity to DTG. These results were not used to pre-define subgroup for analysis.
Time Frame Baseline
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ITT-E Population
Arm/Group Title Cohort I (DTG 50 mg OD) Cohort II (DTG 50 mg BID)
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Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
Participants received DTG 50 mg twice a day (BID).
Overall Number of Participants Analyzed 27 24
Measure Type: Number
Unit of Measure: Participants
Q148 + 2 3 2
Q 148 + 1 4 8
Mixture 2 1
Y143 12 6
N155 4 6
Other 2 1
14.Secondary Outcome
Title Median Fold Change in Sensitivity to DTG by the Baseline (Day 1) IN Mutational Group
Hide Description Summary of median fold change in sensitivity to DTG by Integrase (IN) mutational group was assessed. The IN mutational group comprises of the following mutations: Q148 +2, Q148 +1, mixture (participants with virus containing more than one Y143, Q148 or N155 mutation at Day 1), Y143, N155, other (participants with virus having no mutations at codons 143, 148, or 155 at Day 1). Fold change (FC) is the fold change in 50% Inhibitory Concentration (IC50) relative to the wild-type control virus.
Time Frame Baseline (Day 1)
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ITT-E Population
Arm/Group Title Cohort I (DTG 50 mg OD) Cohort II (DTG 50 mg BID)
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Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
Participants received DTG 50 mg twice a day (BID).
Overall Number of Participants Analyzed 27 24
Median (Full Range)
Unit of Measure: Percentage
Q148 + 2, n=3, 2
21
(14 to 35)
4
(2.1 to 6.0)
Q148 + 1, n=4, 8
5.5
(3.3 to 25)
5.5
(4.1 to 8.2)
Mixture, n=2, 1
7.8
(6.5 to 9.1)
9.48
(9.48 to 9.48)
Y143, n=12, 6
1.1
(0.6 to 1.4)
1.2
(0.92 to 1.8)
N155, n=4, 6
1.8
(1.5 to 5.1)
2.3
(1.3 to 4.0)
Other, n=2, 1
1.2
(0.9 to 1.5)
0.87
(0.87 to 0.87)
15.Secondary Outcome
Title Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance
Hide Description An analysis of changes at specific amino acids in the IN coding region associated with resistance to raltegravir, elvitegravir, or DTG was performed at Day 1 and at the time of PDVF. PDVF is defined in relation to Baseline plasma HIV-1 RNA levels: at Day 11, a decrease of <0.7 log10 c/mL unless <400 c/mL; at Weeks 8 to <16, a decrease of <1.0 log10 c/mL unless <400 c/mL or an increase of >= 1.0 log10 c/mL from nadir; and at or after Week 16, ≥400 c/mL. PDVF at Day 11 was based on a single plasma HIV-1 RNA evaluation and did not require confirmation. Confirmation testing was required for visits at or after Week 8. For the combination treatment phase, all HIV-1 RNA samples that meet a criterion for suspected PDVF must be confirmed by a second measurement performed at least 1 week but not more than 4 weeks apart from the date of the original sample.
Time Frame From Baseline (Day 1) until study completion (median 605 days for Cohort I, median 1181 days for Cohort II)
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On-treatment Genotypic Resistance Population: all ITT-E participants who met the criteria for protocol-defined virological failure (PDVF)
Arm/Group Title Cohort I (DTG 50 mg OD) Cohort II (DTG 50 mg BID)
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
Participants received DTG 50 mg twice a day (BID).
Overall Number of Participants Analyzed 18 7
Measure Type: Number
Unit of Measure: Participants
Any 11 5
E138T 0 1
N155H 3 4
T97A 2 0
E92E/Q 0 1
G140S 3 0
L74I/M 1 0
Q148H 2 0
E138E/A 1 0
E138E/K 1 2
L74I/M/I 1 0
L74M 1 0
L74I 1 0
T97T/A 0 2
Q148R 1 0
S147G 3 0
E92E/V 0 1
L68L/I 1 0
16.Secondary Outcome
Title Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) Between Baseline and the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance
Hide Description The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF.The number of participants with the indicated change (ratio) in the two values at the time of PDVF is presented. PDVF is defined in relation to Baseline plasma HIV-1 RNA levels: at Day 11, a decrease of <0.7 log 10 c/mL unless <400 c/mL; at Weeks 8 to <16, a decrease of <1.0 log 10 c/mL unless <400 c/mL or an increase of >=1.0 log 10 c/mL from nadir; and at or after Week 16, ≥400 c/mL . PDVF at Day 11 was based on a single plasma HIV-1 RNA evaluation and did not require confirmation. Confirmation testing was required for visits at or after Week 8. For the combination treatment phase, all HIV-1 RNA samples that meet a criterion for suspected PDVF must be confirmed by a second measurement performed at least 1 week but not more than 4 weeks apart from the date of original sample.
Time Frame From Baseline (Day 1) until study completion (median 605 days for Cohort I, median 1181 days for Cohort II)
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Hide Analysis Population Description
PDVF Phenotypic Resistance Populations: all participants in the ITT-E Population with available on-treatment phenotypic resistance data at the time of PDVF failure. Only participants with both Baseline and PDVF time-point DTG phenotypic data were considered for analysis.
Arm/Group Title Cohort I (DTG 50 mg OD) Cohort II (DTG 50 mg BID)
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
Participants received DTG 50 mg twice a day (BID).
Overall Number of Participants Analyzed 17 7
Measure Type: Number
Unit of Measure: Participants
<1 fold 3 0
1-<2 fold 4 2
2-<4 fold 1 0
4-<8 fold 1 2
>=8 fold 8 3
17.Secondary Outcome
Title Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities
Hide Description Hematology and clinical chemistry data were summarized according to Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, dated December 2004. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Potentially life-threatening. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. The Grade 3 and Grade 4 clinical chemistry toxicities included: Albumin, Alkaline Phosphatase, Amylase, Aspartate Amino Transferase, Carbon dioxide content/Bicarbonate, Creatinine, Creatinine Clearance, Hypercalcemia, Hyperglycaemia, Hyperkalemia, Hypernatremia, Hypocalcemia, Hypoglycaemia, Hypokalemia, Hyponatremia, LDL Cholesterol, Magnesium, Phosphorus inorganic, and Total Bilirubin, Alanine Amino Transferase, Calcium, Chloride, Cholesterol, Creatine Kinase, Direct Bilirubin, Glucose, High Density Lipid (HDL), Cholesterol direct, Lipase, Potassium, Sodium, Total Cholesterol, Triglycerides, Urea/Blood Urine Nitrogen.
Time Frame From start of study treatment until the end of treatment visit for each participant, up to Week 264 for Cohort I and up to Week 228 for Cohort II
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Safety Population: all participants that took at least one dose of DTG
Arm/Group Title Cohort I (DTG 50 mg OD) Cohort II (DTG 50 mg BID)
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
Participants received DTG 50 mg twice a day (BID).
Overall Number of Participants Analyzed 27 24
Measure Type: Number
Unit of Measure: Participants
Albumin, Grade 3 0 0
Albumin, Grade 4 0 0
Alkaline Phosphatase, Grade 3 0 0
Alkaline Phosphatase, Grade 4 0 0
Amylase, Grade 3 1 2
Amylase, Grade 4 1 0
Aspartate Amino Transferase, Grade 3 0 0
Aspartate Amino Transferase, Grade 4 0 0
Carbon dioxide content/Bicarbonate, Grade 3 0 0
Carbon dioxide content/Bicarbonate, Grade 4 0 0
Creatinine, Grade 3 0 0
Creatinine, Grade 4 0 0
Creatinine Clearance, estimated, Grade 3 0 0
Creatinine Clearance, estimated, Grade 4 0 0
Hypercalcemia, Grade 3 0 0
Hypercalcemia, Grade 4 0 0
Hyperglycaemia, Grade 3 0 0
Hyperglycaemia, Grade 4 0 0
Hyperkalemia, Grade 3 0 0
Hyperkalemia, Grade 4 0 0
Hypernatremia, Grade 3 1 0
Hypernatremia, Grade 4 0 0
Hypocalcemia, Grade 3 0 0
Hypocalcemia, Grade 4 0 0
Hypoglycaemia, Grade 3 1 0
Hypoglycaemia, Grade 4 0 1
Hypokalemia, Grade 3 0 0
Hypokalemia, Grade 4 0 0
Hyponatremia, Grade 3 0 0
Hyponatremia, Grade 4 0 0
LDL Cholesterol, Grade 3 2 1
LDL Cholesterol, Grade 4 0 0
Magnesium, Grade 3 0 0
Magnesium, Grade 4 0 0
Phosphorus inorganic, Grade 3 4 3
Phosphorus inorganic, Grade 4 0 0
Total Bilirubin, Grade 3 0 2
Total Bilirubin, Grade 4 0 1
Alanine Amino Transferase ,Grade 3 0 1
Alanine Amino Transferase ,Grade 4 0 0
Calcium,Grade 3 0 0
Calcium,Grade 4 0 0
Chloride,Grade 3 0 0
Chloride,Grade 4 0 0
Cholesterol,Grade 3 1 1
Cholesterol,Grade 4 0 0
Creatine Kinase,Grade 3 0 0
Creatine Kinase,Grade 4 0 0
Direct Bilirubin,Grade 3 0 0
Direct Bilirubin,Grade 4 0 0
Glucose,Grade 3 1 0
Glucose,Grade 4 0 1
HDL Cholesterol direct,Grade 3 0 0
HDL Cholesterol direct,Grade 4 0 0
Lipase,Grade 3 2 3
Lipase,Grade 4 1 1
Potassium,Grade 3 0 0
Potassium,Grade 4 0 0
Sodium,Grade 3 1 0
Sodium,Grade 4 0 0
Total Cholesterol/HDLratio, Grade 3 0 0
Total Cholesterol/HDLratio, Grade 4 0 0
Triglycerides,Grade 3 0 2
Triglycerides,Grade 4 0 0
Urea/BUN,Grade 3 0 0
Urea/BUN,Grade 4 0 0
18.Secondary Outcome
Title Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities
Hide Description Hematology and clinical chemistry data were summarized according to Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, dated December 2004. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Potentially life-threatening. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. The Grade 3 and Grade 4 hematological toxicities included: Hemoglobin, Platelet Count, Total Neutrophils, and White Blood Cell count.
Time Frame From start of study treatment until the end of treatment visit for each participant, up to Week 264 for Cohort I and up to Week 228 for Cohort II
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Safety Population: all participants that took at least one dose of DTG
Arm/Group Title Cohort I (DTG 50 mg OD) Cohort II (DTG 50 mg BID)
Hide Arm/Group Description:
Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
Participants received DTG 50 mg twice a day (BID).
Overall Number of Participants Analyzed 27 24
Measure Type: Number
Unit of Measure: Participants
Hemoglobin, Grade 3 0 1
Hemoglobin, Grade 4 0 0
Platelet count, Grade 3 0 0
Platelet count, Grade 4 0 0
Total Neutrophils, Grade 3 0 0
Total Neutrophils, Grade 4 0 2
White Blood Cell count, Grade 3 0 0
White Blood Cell, Grade 4 0 1
Time Frame SAEs, non-serious AEs and laboratory toxicities were collected from start of study treatment until the end of treatment visit for each participant, up to Week 264 for Cohort I and up to Week 228 for Cohort II.
Adverse Event Reporting Description SAEs and non-serious AEs were collected in the Safety Population, comprised of all participants that took at least one dose of DTG.
 
Arm/Group Title Cohort I (DTG 50 mg OD) Cohort II (DTG 50 mg BID)
Hide Arm/Group Description Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD). Participants received DTG 50 mg twice a day (BID).
All-Cause Mortality
Cohort I (DTG 50 mg OD) Cohort II (DTG 50 mg BID)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort I (DTG 50 mg OD) Cohort II (DTG 50 mg BID)
Affected / at Risk (%) Affected / at Risk (%)
Total   10/27 (37.04%)   11/24 (45.83%) 
Blood and lymphatic system disorders     
Anaemia  1  0/27 (0.00%)  1/24 (4.17%) 
Febrile bone marrow aplasia  1  1/27 (3.70%)  0/24 (0.00%) 
Febrile neutropenia  1  0/27 (0.00%)  1/24 (4.17%) 
Cardiac disorders     
Coronary artery disease  1  0/27 (0.00%)  2/24 (8.33%) 
Acute myocardial infarction  1  0/27 (0.00%)  1/24 (4.17%) 
Left ventricular dysfunction  1  0/27 (0.00%)  1/24 (4.17%) 
Endocrine disorders     
Hyperthyroidism  1  1/27 (3.70%)  0/24 (0.00%) 
Thyroiditis  1  1/27 (3.70%)  0/24 (0.00%) 
Eye disorders     
Dacryostenosis acquired  1  1/27 (3.70%)  0/24 (0.00%) 
Gastrointestinal disorders     
Anogenital dysplasia  1  1/27 (3.70%)  0/24 (0.00%) 
Diarrhoea  1  0/27 (0.00%)  1/24 (4.17%) 
General disorders     
Chest discomfort  1  0/27 (0.00%)  1/24 (4.17%) 
Hepatobiliary disorders     
Hepatic fibrosis  1  0/27 (0.00%)  1/24 (4.17%) 
Hepatic cirrhosis  1  0/27 (0.00%)  1/24 (4.17%) 
Infections and infestations     
Gastroenteritis viral  1  0/27 (0.00%)  1/24 (4.17%) 
Neurosyphilis  1  1/27 (3.70%)  0/24 (0.00%) 
Pneumonia  1  0/27 (0.00%)  1/24 (4.17%) 
Respiratory tract infection  1  0/27 (0.00%)  1/24 (4.17%) 
Staphylococcal abscess  1  0/27 (0.00%)  1/24 (4.17%) 
Metabolism and nutrition disorders     
Diabetes mellitus  1  0/27 (0.00%)  1/24 (4.17%) 
Haemochromatosis  1  0/27 (0.00%)  1/24 (4.17%) 
Hypoalbuminaemia  1  0/27 (0.00%)  1/24 (4.17%) 
Hypokalaemia  1  0/27 (0.00%)  1/24 (4.17%) 
Body fat disorder  1  1/27 (3.70%)  0/24 (0.00%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis  1  1/27 (3.70%)  0/24 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Central nervous system lymphoma  1  0/27 (0.00%)  1/24 (4.17%) 
Immunoblastic lymphoma  1  1/27 (3.70%)  0/24 (0.00%) 
Uterine leiomyoma  1  1/27 (3.70%)  1/24 (4.17%) 
B-cell lymphoma  1  0/27 (0.00%)  1/24 (4.17%) 
Breast cancer  1  0/27 (0.00%)  1/24 (4.17%) 
Nervous system disorders     
Brain mass  1  1/27 (3.70%)  0/24 (0.00%) 
Demyelinating polyneuropathy  1  0/27 (0.00%)  1/24 (4.17%) 
Convulsion  1  0/27 (0.00%)  1/24 (4.17%) 
Psychiatric disorders     
Completed suicide  1  0/27 (0.00%)  1/24 (4.17%) 
Renal and urinary disorders     
Renal failure acute  1  1/27 (3.70%)  0/24 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/27 (3.70%)  0/24 (0.00%) 
Acute pulmonary oedema  1  1/27 (3.70%)  0/24 (0.00%) 
Vascular disorders     
Cryoglobulinaemia  1  1/27 (3.70%)  0/24 (0.00%) 
Deep vein thrombosis  1  0/27 (0.00%)  1/24 (4.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort I (DTG 50 mg OD) Cohort II (DTG 50 mg BID)
Affected / at Risk (%) Affected / at Risk (%)
Total   25/27 (92.59%)   22/24 (91.67%) 
Blood and lymphatic system disorders     
Lymphadenopathy  1  2/27 (7.41%)  4/24 (16.67%) 
Cardiac disorders     
Angina pectoris  1  0/27 (0.00%)  2/24 (8.33%) 
Ear and labyrinth disorders     
Vertigo  1  2/27 (7.41%)  0/24 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  1  8/27 (29.63%)  9/24 (37.50%) 
Abdominal pain upper  1  3/27 (11.11%)  3/24 (12.50%) 
Constipation  1  3/27 (11.11%)  2/24 (8.33%) 
Gastrooesophageal reflux disease  1  3/27 (11.11%)  2/24 (8.33%) 
Nausea  1  2/27 (7.41%)  3/24 (12.50%) 
Abdominal distension  1  2/27 (7.41%)  2/24 (8.33%) 
Abdominal pain  1  4/27 (14.81%)  0/24 (0.00%) 
Vomiting  1  2/27 (7.41%)  3/24 (12.50%) 
Defaecation urgency  1  0/27 (0.00%)  2/24 (8.33%) 
Anogenital dysplasia  1  2/27 (7.41%)  0/24 (0.00%) 
General disorders     
Pyrexia  1  3/27 (11.11%)  7/24 (29.17%) 
Asthenia  1  6/27 (22.22%)  3/24 (12.50%) 
Fatigue  1  0/27 (0.00%)  4/24 (16.67%) 
Influenza like illness  1  0/27 (0.00%)  2/24 (8.33%) 
Injection site reaction  1  0/27 (0.00%)  2/24 (8.33%) 
Oedema peripherial  1  4/27 (14.81%)  2/24 (8.33%) 
Malaise  1  0/27 (0.00%)  2/24 (8.33%) 
Immune system disorders     
Seasonal allergy  1  2/27 (7.41%)  0/24 (0.00%) 
Infections and infestations     
Bronchitis  1  6/27 (22.22%)  7/24 (29.17%) 
Rhinitis  1  0/27 (0.00%)  2/24 (8.33%) 
Sinusitis  1  0/27 (0.00%)  2/24 (8.33%) 
Upper respiratory tract infection  1  2/27 (7.41%)  5/24 (20.83%) 
Urinary tract infection  1  0/27 (0.00%)  3/24 (12.50%) 
Herpes virus infection  1  2/27 (7.41%)  0/24 (0.00%) 
Influenza  1  3/27 (11.11%)  0/24 (0.00%) 
Oral herpes  1  3/27 (11.11%)  0/24 (0.00%) 
Tooth abscess  1  0/27 (0.00%)  2/24 (8.33%) 
Nasopharyngitis  1  2/27 (7.41%)  2/24 (8.33%) 
Gastroenteritis viral  1  3/27 (11.11%)  0/24 (0.00%) 
Ear infection  1  2/27 (7.41%)  0/24 (0.00%) 
Genital herpes  1  2/27 (7.41%)  0/24 (0.00%) 
Otitis media  1  2/27 (7.41%)  0/24 (0.00%) 
Investigations     
Lipase increased  1  0/27 (0.00%)  3/24 (12.50%) 
Weight decreased  1  2/27 (7.41%)  0/24 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  2/27 (7.41%)  0/24 (0.00%) 
Hypercholesterolaemia  1  2/27 (7.41%)  0/24 (0.00%) 
Vitamin D deficiency  1  2/27 (7.41%)  0/24 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  5/27 (18.52%)  2/24 (8.33%) 
Myalgia  1  4/27 (14.81%)  0/24 (0.00%) 
Backpain  1  3/27 (11.11%)  3/24 (12.50%) 
Pain in extremity  1  0/27 (0.00%)  4/24 (16.67%) 
Osteoarthritis  1  3/27 (11.11%)  0/24 (0.00%) 
Muscle spasms  1  0/27 (0.00%)  2/24 (8.33%) 
Tendonitis  1  0/27 (0.00%)  2/24 (8.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Anogenital warts  1  0/27 (0.00%)  2/24 (8.33%) 
Nervous system disorders     
Headache  1  4/27 (14.81%)  3/24 (12.50%) 
Sciatica  1  2/27 (7.41%)  2/24 (8.33%) 
Dizziness  1  0/27 (0.00%)  2/24 (8.33%) 
Dysaesthesia  1  2/27 (7.41%)  0/24 (0.00%) 
Anxiety  1  0/27 (0.00%)  2/24 (8.33%) 
Psychiatric disorders     
Insomnia  1  5/27 (18.52%)  2/24 (8.33%) 
Depressed mood  1  0/27 (0.00%)  2/24 (8.33%) 
Depression  1  0/27 (0.00%)  2/24 (8.33%) 
Renal and urinary disorders     
Pollakiuria  1  0/27 (0.00%)  3/24 (12.50%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  5/27 (18.52%)  7/24 (29.17%) 
Sinus congestion  1  0/27 (0.00%)  4/24 (16.67%) 
Rhinorrhoea  1  0/27 (0.00%)  3/24 (12.50%) 
Dyspnoea  1  2/27 (7.41%)  2/24 (8.33%) 
Oropharyngeal pain  1  0/27 (0.00%)  3/24 (12.50%) 
Nasal congestion  1  0/27 (0.00%)  2/24 (8.33%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  3/27 (11.11%)  0/24 (0.00%) 
Hyperhidrosis  1  2/27 (7.41%)  0/24 (0.00%) 
Intertrigo  1  2/27 (7.41%)  0/24 (0.00%) 
Vascular disorders     
Hypertension  1  2/27 (7.41%)  0/24 (0.00%) 
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
Name/Title: GSK Response Center
Organization: ViiV Healthcare
Phone: 866-435-7343
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00950859     History of Changes
Other Study ID Numbers: 112961
First Submitted: July 23, 2009
First Posted: August 3, 2009
Results First Submitted: August 15, 2013
Results First Posted: October 21, 2013
Last Update Posted: December 4, 2015