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Evaluating the Safety, Tolerability, and Pharmacokinetics of an Investigational, Injectable HIV Medicine (GSK1265744) in HIV-Uninfected Adults

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: NCT02178800
Recruitment Status : Completed
First Posted : July 1, 2014
Results First Posted : July 5, 2018
Last Update Posted : March 13, 2020
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition HIV Infections
Interventions Drug: GSK1265744 Tablets
Drug: Injectable GSK1265744
Drug: Placebo for GSK1265744 Tablets
Drug: Injectable Placebo for GSK1265744
Enrollment 199
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1: GSK1265744 Group 2: Placebo
Hide Arm/Group Description

Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744—at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.

GSK1265744 Tablets: 30-mg tablets, taken orally

Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections

Cohort 2: 600-mg injection, administered as one IM gluteal injection

Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo—at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.

Placebo for GSK1265744 Tablets: Taken orally

Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections

Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection

Period Title: Overall Study
Started 151 48
Completed 131 [1] 42 [1]
Not Completed 20 6
[1]
Number of participants who weren't terminated at week 41
Arm/Group Title Group 1: GSK1265744 Group 2: Placebo Total
Hide Arm/Group Description

Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744—at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.

GSK1265744 Tablets: 30-mg tablets, taken orally

Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections

Cohort 2: 600-mg injection, administered as one IM gluteal injection

Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo—at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.

Placebo for GSK1265744 Tablets: Taken orally

Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections

Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection

Total of all reporting groups
Overall Number of Baseline Participants 151 48 199
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 151 participants 48 participants 199 participants
33  (11.4) 35  (11.0) 33  (11.3)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants 48 participants 199 participants
18 - 25
52
  34.4%
9
  18.8%
61
  30.7%
26 - 35
53
  35.1%
17
  35.4%
70
  35.2%
36 - 45
21
  13.9%
14
  29.2%
35
  17.6%
46 - 55
15
   9.9%
4
   8.3%
19
   9.5%
56 - 65
10
   6.6%
4
   8.3%
14
   7.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants 48 participants 199 participants
Female
100
  66.2%
32
  66.7%
132
  66.3%
Male
51
  33.8%
16
  33.3%
67
  33.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants 48 participants 199 participants
Latino
36
  23.8%
11
  22.9%
47
  23.6%
Non-hispanic Asian
3
   2.0%
2
   4.2%
5
   2.5%
Non-hispanic Black
64
  42.4%
18
  37.5%
82
  41.2%
Non-hispanic White
42
  27.8%
12
  25.0%
54
  27.1%
Non-hispanic mixed/other
6
   4.0%
5
  10.4%
11
   5.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants 48 participants 199 participants
United States
80
  53.0%
26
  54.2%
106
  53.3%
Malawi
14
   9.3%
3
   6.3%
17
   8.5%
Brazil
24
  15.9%
10
  20.8%
34
  17.1%
South Africa
33
  21.9%
9
  18.8%
42
  21.1%
1.Primary Outcome
Title Number of Participants Experiencing Any Grade 2 or Higher Clinical Adverse Events (AEs) and Laboratory Abnormalities That Occur From the Initial Injection to Week 41 Among Participants Who Receive at Least One Injection (Injectable Phase Only)
Hide Description An adverse events (AE) or laboratory abnormality can be an unfavorable or unintended sign, symptom or disease temporally associated with the use of an investigational product, whether or not considered related to the product. AE severity was graded per the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 2.0, November 2014. The outcome in this table is stratified by arm.
Time Frame Measured through Week 41
Hide Outcome Measure Data
Hide Analysis Population Description
This population includes participants who receive at least one injection in the study.
Arm/Group Title Group 1: GSK1265744 Group 2: Placebo
Hide Arm/Group Description:

Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744—at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.

GSK1265744 Tablets: 30-mg tablets, taken orally

Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections

Cohort 2: 600-mg injection, administered as one IM gluteal injection

Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo—at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.

Placebo for GSK1265744 Tablets: Taken orally

Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections

Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection

Overall Number of Participants Analyzed 134 43
Measure Type: Count of Participants
Unit of Measure: Participants
121
  90.3%
38
  88.4%
2.Primary Outcome
Title Number of Participants Who Discontinue Injectable Study Product for Reasons of Toxicity, Tolerability, or Acceptability That Occur From the Initial Injection to Week 41 Among Participants Who Receive at Least One Injection (Injectable Phase Only)
Hide Description Stratified by arm
Time Frame Measured through Week 41
Hide Outcome Measure Data
Hide Analysis Population Description
This population includes participants who received at least one injection in the study.
Arm/Group Title Group 1: GSK1265744 Group 2: Placebo
Hide Arm/Group Description:

Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744—at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.

GSK1265744 Tablets: 30-mg tablets, taken orally

Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections

Cohort 2: 600-mg injection, administered as one IM gluteal injection

Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo—at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.

Placebo for GSK1265744 Tablets: Taken orally

Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections

Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection

Overall Number of Participants Analyzed 134 43
Measure Type: Count of Participants
Unit of Measure: Participants
11
   8.2%
2
   4.7%
3.Primary Outcome
Title Plasma Drug Levels of GSK1265744 at Designated Time Points After Each Injection of 744LA (Injectable Formulation of GSK1265744)
Hide Description Geometric means and 90% prediction intervals by sex at birth and cohort are reported.
Time Frame Measured through Week 41
Hide Outcome Measure Data
Hide Analysis Population Description
PK sample size varies by visit due to reasons such as missing visits, different schedule and sample contamination.
Arm/Group Title Female, Cohort 1 Male, Cohort 1 Female, Cohort 2 Male, Cohort 2
Hide Arm/Group Description:
Female, GSK1265744 arm, Cohort 1 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,13,17,18,23,29,30,35 and 41 are measured.
Male, GSK1265744 arm, Cohort 1 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,13,17,18,23,29,30,35 and 41 are measured.
Female, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
Male, GSK1265744 arm, Cohort 2 participants who received at least one injection only. Plasma drug concentrations at Week 6, 9,10,13,17,18,21,25,26,29,33,34,37 and 41 are measured.
Overall Number of Participants Analyzed 49 25 40 20
Geometric Mean (90% Confidence Interval)
Unit of Measure: ug/ml
Week 6 Number Analyzed 49 participants 25 participants 40 participants 20 participants
1.32
(0.49 to 3.54)
2.40
(0.63 to 9.22)
1.29
(0.33 to 5.05)
2.28
(0.67 to 7.72)
Week 9 Number Analyzed 49 participants 25 participants 39 participants 20 participants
1.49
(0.53 to 4.18)
1.77
(0.70 to 4.47)
1.31
(0.38 to 4.44)
1.79
(0.93 to 3.44)
Week 10 Number Analyzed 0 participants 0 participants 39 participants 20 participants
2.56
(0.94 to 6.98)
3.58
(1.42 to 9.00)
Week 13 Number Analyzed 49 participants 25 participants 39 participants 20 participants
1.18
(0.52 to 2.69)
0.90
(0.40 to 2.01)
2.24
(0.89 to 5.65)
2.55
(1.22 to 5.33)
Week 17 Number Analyzed 49 participants 25 participants 39 participants 20 participants
0.95
(0.42 to 2.14)
0.49
(0.19 to 1.31)
1.82
(0.79 to 4.21)
1.29
(0.54 to 3.09)
Week 18 Number Analyzed 40 participants 23 participants 38 participants 20 participants
2.11
(0.94 to 4.75)
2.33
(0.72 to 7.53)
3.09
(1.32 to 7.25)
2.73
(1.03 to 7.29)
Week 21 Number Analyzed 0 participants 0 participants 38 participants 20 participants
2.74
(1.29 to 5.79)
2.07
(0.87 to 4.90)
Week 23 Number Analyzed 40 participants 23 participants 0 participants 0 participants
2.02
(0.86 to 4.74)
1.48
(0.84 to 2.59)
Week 25 Number Analyzed 0 participants 0 participants 37 participants 20 participants
2.00
(0.96 to 4.16)
1.11
(0.38 to 3.20)
Week 26 Number Analyzed 0 participants 0 participants 38 participants 20 participants
3.07
(1.30 to 7.27)
2.84
(1.24 to 6.49)
Week 29 Number Analyzed 39 participants 23 participants 38 participants 20 participants
1.37
(0.61 to 3.06)
0.78
(0.30 to 2.02)
2.68
(1.23 to 5.81)
2.17
(0.98 to 4.81)
Week 30 Number Analyzed 35 participants 23 participants 0 participants 0 participants
2.78
(1.23 to 6.28)
3.48
(1.43 to 8.48)
Week 33 Number Analyzed 0 participants 0 participants 36 participants 19 participants
2.10
(0.94 to 4.70)
1.50
(0.55 to 4.11)
Week 34 Number Analyzed 0 participants 0 participants 35 participants 19 participants
3.59
(1.50 to 8.58)
3.60
(1.48 to 8.74)
Week 35 Number Analyzed 35 participants 23 participants 0 participants 0 participants
2.41
(1.03 to 5.61)
1.85
(1.07 to 3.20)
Week 37 Number Analyzed 0 participants 0 participants 36 participants 18 participants
2.73
(1.06 to 7.06)
2.71
(1.67 to 4.40)
Week 41 Number Analyzed 36 participants 22 participants 35 participants 18 participants
1.68
(0.78 to 3.62)
0.82
(0.27 to 2.54)
2.06
(0.77 to 5.49)
1.68
(0.68 to 4.17)
4.Secondary Outcome
Title Number of Participants Experiencing Grade 2 or Higher Clinical Adverse Events (AEs) and Laboratory Abnormalities During Tail Phase
Hide Description An adverse events (AE) or laboratory abnormality can be an unfavorable or unintended sign, symptom or disease temporally associated with the use of an investigational product, whether or not considered related to the product. AE severity was graded per the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 2.0, November 2014. The outcome in this table is stratified by arm.
Time Frame Measured from 12 weeks after last injection through Week 105 for Cohort 1 and 8 weeks after last injection through Week 109 for Cohort 2
Hide Outcome Measure Data
Hide Analysis Population Description
This includes participants who entered tail phase
Arm/Group Title Group 1: GSK1265744 Group 2: Placebo
Hide Arm/Group Description:

Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744—at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.

GSK1265744 Tablets: 30-mg tablets, taken orally

Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections

Cohort 2: 600-mg injection, administered as one IM gluteal injection

Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo—at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.

Placebo for GSK1265744 Tablets: Taken orally

Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections

Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection

Overall Number of Participants Analyzed 130 42
Measure Type: Count of Participants
Unit of Measure: Participants
107
  82.3%
18
  42.9%
5.Secondary Outcome
Title Number of Participants Experiencing Grade 2 or Higher Clinical Adverse Events (AEs) and Laboratory Abnormalities Prior to Completion of the Oral Phase
Hide Description An adverse events (AE) or laboratory abnormality can be an unfavorable or unintended sign, symptom or disease temporally associated with the use of an investigational product, whether or not considered related to the product. AE severity was graded per the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 2.0, November 2014. The outcome in this table is stratified by arm.
Time Frame Measured through Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1: GSK1265744 Group 2: Placebo
Hide Arm/Group Description:

Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744—at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.

GSK1265744 Tablets: 30-mg tablets, taken orally

Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections

Cohort 2: 600-mg injection, administered as one IM gluteal injection

Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo—at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.

Placebo for GSK1265744 Tablets: Taken orally

Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections

Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection

Overall Number of Participants Analyzed 151 48
Measure Type: Count of Participants
Unit of Measure: Participants
84
  55.6%
25
  52.1%
6.Secondary Outcome
Title Number of Participants Willing to Use an Injectable Agent Such as the Study Product for HIV Prevention in the Future
Hide Description Stratified by Visit and Cohort
Time Frame Measured from week 6 through Week 30 in cohort 1 and Week 34 in cohort 2
Hide Outcome Measure Data
Hide Analysis Population Description
Sample size varies by visit due to reasons such as missing visits and different schedules.
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description:
Participants who were planned to receive IM injections of 744LA or placebo at three time points at 12 week intervals.Two sequential 400 mg gluteal injections were given at each injection visit (if not discontinued).
participants who were planned to receive IM injections of 744LA or placebo at five time points at 4 and 8 week intervals.One 600 mg gluteal injection was given at each injection visit (if not discontinued).
Overall Number of Participants Analyzed 98 78
Measure Type: Count of Participants
Unit of Measure: Participants
Week 6 Number Analyzed 98 participants 78 participants
80
  81.6%
74
  94.9%
Week 10 Number Analyzed 0 participants 77 participants
74
  96.1%
Week 18 Number Analyzed 88 participants 75 participants
81
  92.0%
73
  97.3%
Week 26 Number Analyzed 0 participants 75 participants
71
  94.7%
Week 30 Number Analyzed 77 participants 0 participants
69
  89.6%
Week 34 Number Analyzed 0 participants 70 participants
65
  92.9%
7.Secondary Outcome
Title Number of Participants With HIV Infections Through the Study Period, Stratified by Arm
Hide Description [Not Specified]
Time Frame Measured through Week 105 for Cohort 1 and Week 109 for Cohort 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1: GSK1265744 Group 2: Placebo
Hide Arm/Group Description:

Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744—at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.

GSK1265744 Tablets: 30-mg tablets, taken orally

Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections

Cohort 2: 600-mg injection, administered as one IM gluteal injection

Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo—at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.

Placebo for GSK1265744 Tablets: Taken orally

Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections

Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection

Overall Number of Participants Analyzed 151 48
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.7%
0
   0.0%
8.Secondary Outcome
Title Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period
Hide Description Week 29/31 is a combination of week 29, cohort 1 and week 33, cohort 2. The outcome in this table is stratified by arm.
Time Frame Measured through Week 77
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis sample size is different at each visit due to multiple reasons (early termination, missing data, study unblinding, etc.)
Arm/Group Title Group 1: GSK1265744 Group 2: Placebo
Hide Arm/Group Description:

Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744—at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.

GSK1265744 Tablets: 30-mg tablets, taken orally Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections Cohort 2: 600-mg injection, administered as one IM gluteal injection

Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo—at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.

Placebo for GSK1265744 Tablets: Taken orally Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection

Overall Number of Participants Analyzed 151 48
Mean (Standard Deviation)
Unit of Measure: partners
Enrollment Visit Number Analyzed 151 participants 48 participants
0.81  (0.46) 0.92  (0.65)
Week 5 Number Analyzed 134 participants 45 participants
0.84  (0.44) 0.78  (0.67)
Week 17 Number Analyzed 132 participants 43 participants
0.81  (0.54) 0.84  (0.57)
Week 29/33 Number Analyzed 125 participants 41 participants
0.85  (0.57) 0.80  (0.46)
Week 41 Number Analyzed 130 participants 42 participants
0.85  (0.66) 0.88  (0.45)
Week 53 Number Analyzed 129 participants 41 participants
0.84  (0.62) 0.83  (0.50)
Week 65 Number Analyzed 115 participants 33 participants
0.87  (0.76) 0.88  (0.48)
Week 77 Number Analyzed 110 participants 22 participants
0.84  (0.61) 0.82  (0.50)
9.Secondary Outcome
Title Number of Injectable Hormonal-contraception-using Female Participants Experiencing Grade 2 or Higher Clinical AE and Laboratory Abnormalities During Oral Phase
Hide Description An adverse events (AE) or laboratory abnormality can be an unfavorable or unintended sign, symptom or disease temporally associated with the use of an investigational product, whether or not considered related to the product. AE severity was graded per the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 2.0, November 2014. The outcome in this table is stratified by arm.
Time Frame Measured through Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
This population includes injectable hormonal-contraception-using female participants in the study
Arm/Group Title Group 1: GSK1265744 Group 2: Placebo
Hide Arm/Group Description:

Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744—at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.

GSK1265744 Tablets: 30-mg tablets, taken orally

Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections

Cohort 2: 600-mg injection, administered as one IM gluteal injection

Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo—at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.

Placebo for GSK1265744 Tablets: Taken orally

Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections

Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection

Overall Number of Participants Analyzed 34 13
Measure Type: Count of Participants
Unit of Measure: Participants
17
  50.0%
7
  53.8%
10.Secondary Outcome
Title Number of Injectable Hormonal-contraception-using Female Participants Experiencing Grade 2 or Higher Clinical AE and Laboratory Abnormalities During Injection Phase
Hide Description [Not Specified]
Time Frame Measured from first injection through 12 weeks after last injection for Cohort 1 and 8 weeks after last injection for Cohort 2
Hide Outcome Measure Data
Hide Analysis Population Description
This population includes injectable hormonal-contraception-using female participants who received at least one injection of study drug in the study
Arm/Group Title Group 1: GSK1265744 Group 2: Placebo
Hide Arm/Group Description:

Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744—at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.

GSK1265744 Tablets: 30-mg tablets, taken orally

Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections

Cohort 2: 600-mg injection, administered as one IM gluteal injection

Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo—at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.

Placebo for GSK1265744 Tablets: Taken orally

Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections

Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection

Overall Number of Participants Analyzed 32 12
Measure Type: Count of Participants
Unit of Measure: Participants
29
  90.6%
12
 100.0%
11.Secondary Outcome
Title Number of Injectable Hormonal-contraception-using Female Participants Who Discontinue Study Product for Reasons of Toxicity, Tolerability, or Acceptability During Oral Phase
Hide Description Stratified by arm
Time Frame Measured through Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
This population includes injectable hormonal-contraception-using female participants in the study
Arm/Group Title Group 1: GSK1265744 Group 2: Placebo
Hide Arm/Group Description:

Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744—at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.

GSK1265744 Tablets: 30-mg tablets, taken orally

Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections

Cohort 2: 600-mg injection, administered as one IM gluteal injection

Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo—at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.

Placebo for GSK1265744 Tablets: Taken orally

Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections

Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection

Overall Number of Participants Analyzed 34 13
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
12.Secondary Outcome
Title Number of Injectable Hormonal-contraception-using Female Participants Who Discontinue Study Product for Reasons of Toxicity, Tolerability, or Acceptability During Injection Phase
Hide Description [Not Specified]
Time Frame Measured from first injection through 12 weeks after last injection for Cohort 1 and 8 weeks after last injection for Cohort 2
Hide Outcome Measure Data
Hide Analysis Population Description
This population includes injectable hormonal-contraception-using female participants who received at least one injection of study drug in the study
Arm/Group Title Group 1: GSK1265744 Group 2: Placebo
Hide Arm/Group Description:

Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744—at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.

GSK1265744 Tablets: 30-mg tablets, taken orally

Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections

Cohort 2: 600-mg injection, administered as one IM gluteal injection

Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo—at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.

Placebo for GSK1265744 Tablets: Taken orally

Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections

Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection

Overall Number of Participants Analyzed 32 12
Measure Type: Count of Participants
Unit of Measure: Participants
3
   9.4%
0
   0.0%
13.Secondary Outcome
Title Number of Participants Who Discontinue Oral Study Product for Reasons of Toxicity, Tolerability, or Acceptability Prior to Completion of the Oral Phase
Hide Description Stratified by arm
Time Frame Measured through Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1: GSK1265744 Group 2: Placebo
Hide Arm/Group Description:

Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744—at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.

GSK1265744 Tablets: 30-mg tablets, taken orally

Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections

Cohort 2: 600-mg injection, administered as one IM gluteal injection

Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo—at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.

Placebo for GSK1265744 Tablets: Taken orally

Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections

Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection

Overall Number of Participants Analyzed 151 48
Measure Type: Count of Participants
Unit of Measure: Participants
6
   4.0%
0
   0.0%
Time Frame 41 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1: GSK1265744 Group 2: Placebo
Hide Arm/Group Description

Participants in Cohorts 1 and 2 will receive one GSK1265744 tablet orally every day from study entry through Week 4. They will then receive an injection of GSK1265744—at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.

GSK1265744 Tablets: 30-mg tablets, taken orally

Injectable GSK1265744: Cohort 1: 800-mg injection, administered as two 400-mg intramuscular (IM) gluteal injections

Cohort 2: 600-mg injection, administered as one IM gluteal injection

Participants in Cohorts 1 and 2 will receive one placebo tablet orally every day from study entry through Week 4. They will then receive an injection of placebo—at Weeks 5, 17, and 29 for participants in Cohort 1 and at Weeks 5, 9, 17, 25, and 33 for participants in Cohort 2.

Placebo for GSK1265744 Tablets: Taken orally

Injectable Placebo for GSK1265744: Cohort 1: Sodium Chloride for Injection USP, 0.9%; administered as two 400-mg IM gluteal injections

Cohort 2: Sodium Chloride for Injection USP, 0.9%; administered as one 600-mg IM gluteal injection

All-Cause Mortality
Group 1: GSK1265744 Group 2: Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/151 (0.00%)      0/48 (0.00%)    
Hide Serious Adverse Events
Group 1: GSK1265744 Group 2: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/151 (2.65%)      2/48 (4.17%)    
Ear and labyrinth disorders     
Vertigo positional *  1/151 (0.66%)  1 0/48 (0.00%)  0
Hepatobiliary disorders     
Cholelithiasis *  0/151 (0.00%)  0 1/48 (2.08%)  1
Infections and infestations     
Laryngitis bacterial *  1/151 (0.66%)  1 0/48 (0.00%)  0
Nervous system disorders     
Sensory loss *  1/151 (0.66%)  1 0/48 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous *  0/151 (0.00%)  0 1/48 (2.08%)  1
Renal and urinary disorders     
Acute kidney injury *  1/151 (0.66%)  1 0/48 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1: GSK1265744 Group 2: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   147/151 (97.35%)      48/48 (100.00%)    
Blood and lymphatic system disorders     
Anaemia *  1/151 (0.66%)  2 0/48 (0.00%)  0
Hypochromic anaemia *  1/151 (0.66%)  1 0/48 (0.00%)  0
Lymphopenia *  1/151 (0.66%)  1 0/48 (0.00%)  0
Cardiac disorders     
Bradycardia *  1/151 (0.66%)  2 0/48 (0.00%)  0
Sinus arrhythmia *  3/151 (1.99%)  3 1/48 (2.08%)  1
Sinus bradycardia *  2/151 (1.32%)  2 1/48 (2.08%)  1
Tachycardia *  0/151 (0.00%)  0 1/48 (2.08%)  2
Ear and labyrinth disorders     
Ear pain *  2/151 (1.32%)  2 3/48 (6.25%)  4
External ear inflammation *  0/151 (0.00%)  0 1/48 (2.08%)  1
Motion sickness *  1/151 (0.66%)  1 0/48 (0.00%)  0
Vertigo *  2/151 (1.32%)  2 0/48 (0.00%)  0
Eye disorders     
Conjunctivitis allergic *  2/151 (1.32%)  2 0/48 (0.00%)  0
Eye irritation *  1/151 (0.66%)  1 0/48 (0.00%)  0
Eye pruritus *  1/151 (0.66%)  1 0/48 (0.00%)  0
Night blindness *  1/151 (0.66%)  1 0/48 (0.00%)  0
Photophobia *  1/151 (0.66%)  1 0/48 (0.00%)  0
Pseudopapilloedema *  1/151 (0.66%)  1 0/48 (0.00%)  0
Vision blurred *  1/151 (0.66%)  1 0/48 (0.00%)  0
Visual impairment *  0/151 (0.00%)  0 2/48 (4.17%)  2
Gastrointestinal disorders     
Abdominal discomfort *  2/151 (1.32%)  3 0/48 (0.00%)  0
Abdominal distension *  2/151 (1.32%)  2 0/48 (0.00%)  0
Abdominal pain *  7/151 (4.64%)  9 0/48 (0.00%)  0
Abdominal pain lower *  0/151 (0.00%)  0 1/48 (2.08%)  1
Abdominal pain upper *  3/151 (1.99%)  4 1/48 (2.08%)  1
Anal fissure *  1/151 (0.66%)  2 0/48 (0.00%)  0
Chronic gastritis *  1/151 (0.66%)  1 0/48 (0.00%)  0
Constipation *  5/151 (3.31%)  6 2/48 (4.17%)  2
Defaecation urgency *  0/151 (0.00%)  0 1/48 (2.08%)  1
Diarrhoea *  13/151 (8.61%)  16 6/48 (12.50%)  10
Dry mouth *  4/151 (2.65%)  4 0/48 (0.00%)  0
Dyspepsia *  1/151 (0.66%)  1 2/48 (4.17%)  2
Faeces soft *  1/151 (0.66%)  1 0/48 (0.00%)  0
Flatulence *  2/151 (1.32%)  2 1/48 (2.08%)  1
Food poisoning *  4/151 (2.65%)  4 0/48 (0.00%)  0
Gastritis *  5/151 (3.31%)  5 0/48 (0.00%)  0
Gastrooesophageal reflux disease *  3/151 (1.99%)  3 0/48 (0.00%)  0
Haematochezia *  1/151 (0.66%)  1 0/48 (0.00%)  0
Haemorrhoids *  1/151 (0.66%)  1 0/48 (0.00%)  0
Mouth ulceration *  1/151 (0.66%)  1 0/48 (0.00%)  0
Nausea *  18/151 (11.92%)  23 5/48 (10.42%)  7
Paraesthesia oral *  0/151 (0.00%)  0 2/48 (4.17%)  2
Tongue coated *  1/151 (0.66%)  1 0/48 (0.00%)  0
Tooth impacted *  1/151 (0.66%)  1 0/48 (0.00%)  0
Toothache *  3/151 (1.99%)  3 0/48 (0.00%)  0
Trichoglossia *  1/151 (0.66%)  1 0/48 (0.00%)  0
Umbilical hernia *  1/151 (0.66%)  1 0/48 (0.00%)  0
Vomiting *  9/151 (5.96%)  14 2/48 (4.17%)  3
General disorders     
Chest pain *  5/151 (3.31%)  5 0/48 (0.00%)  0
Chills *  1/151 (0.66%)  1 0/48 (0.00%)  0
Complication associated with device *  1/151 (0.66%)  1 0/48 (0.00%)  0
Complication of device insertion *  1/151 (0.66%)  1 0/48 (0.00%)  0
Complication of device removal *  1/151 (0.66%)  1 0/48 (0.00%)  0
Fatigue *  11/151 (7.28%)  15 6/48 (12.50%)  7
Feeling hot *  1/151 (0.66%)  1 0/48 (0.00%)  0
Feeling jittery *  0/151 (0.00%)  0 1/48 (2.08%)  1
Hunger *  0/151 (0.00%)  0 1/48 (2.08%)  1
Implant site pain *  1/151 (0.66%)  1 0/48 (0.00%)  0
Induration *  2/151 (1.32%)  2 0/48 (0.00%)  0
Inflammation *  1/151 (0.66%)  1 0/48 (0.00%)  0
Influenza like illness *  15/151 (9.93%)  19 1/48 (2.08%)  1
Injection site bruising *  19/151 (12.58%)  23 2/48 (4.17%)  2
Injection site dermatitis *  1/151 (0.66%)  1 0/48 (0.00%)  0
Injection site discomfort *  1/151 (0.66%)  1 0/48 (0.00%)  0
Injection site erythema *  10/151 (6.62%)  16 0/48 (0.00%)  0
Injection site induration *  24/151 (15.89%)  39 1/48 (2.08%)  2
Injection site nodule *  7/151 (4.64%)  9 0/48 (0.00%)  0
Injection site pain *  120/151 (79.47%)  567 11/48 (22.92%)  29
Injection site pruritus *  4/151 (2.65%)  6 0/48 (0.00%)  0
Injection site reaction *  4/151 (2.65%)  5 0/48 (0.00%)  0
Injection site swelling *  11/151 (7.28%)  17 0/48 (0.00%)  0
Injection site warmth *  3/151 (1.99%)  4 0/48 (0.00%)  0
Malaise *  2/151 (1.32%)  2 0/48 (0.00%)  0
Oedema peripheral *  3/151 (1.99%)  3 0/48 (0.00%)  0
Pain *  2/151 (1.32%)  2 1/48 (2.08%)  1
Puncture site pain *  1/151 (0.66%)  1 0/48 (0.00%)  0
Pyrexia *  9/151 (5.96%)  10 0/48 (0.00%)  0
Thirst *  1/151 (0.66%)  2 1/48 (2.08%)  1
Vessel puncture site haematoma *  1/151 (0.66%)  1 0/48 (0.00%)  0
Vessel puncture site pain *  0/151 (0.00%)  0 1/48 (2.08%)  1
Xerosis *  1/151 (0.66%)  1 0/48 (0.00%)  0
Immune system disorders     
Hypersensitivity *  3/151 (1.99%)  3 1/48 (2.08%)  1
Seasonal allergy *  1/151 (0.66%)  1 1/48 (2.08%)  1
Infections and infestations     
Acute sinusitis *  1/151 (0.66%)  1 0/48 (0.00%)  0
Bacterial vaginosis *  3/151 (1.99%)  3 2/48 (4.17%)  2
Body tinea *  6/151 (3.97%)  6 1/48 (2.08%)  1
Breast cellulitis *  1/151 (0.66%)  1 0/48 (0.00%)  0
Bronchitis *  2/151 (1.32%)  2 0/48 (0.00%)  0
Campylobacter infection *  1/151 (0.66%)  1 0/48 (0.00%)  0
Cellulitis *  1/151 (0.66%)  1 0/48 (0.00%)  0
Cervicitis *  0/151 (0.00%)  0 1/48 (2.08%)  1
Chikungunya virus infection *  2/151 (1.32%)  2 1/48 (2.08%)  1
Chlamydial infection *  2/151 (1.32%)  2 0/48 (0.00%)  0
Conjunctivitis *  7/151 (4.64%)  8 1/48 (2.08%)  1
Conjunctivitis bacterial *  2/151 (1.32%)  2 0/48 (0.00%)  0
Conjunctivitis viral *  1/151 (0.66%)  1 0/48 (0.00%)  0
Cutaneous sporotrichosis *  1/151 (0.66%)  1 0/48 (0.00%)  0
Escherichia urinary tract infection *  1/151 (0.66%)  1 0/48 (0.00%)  0
Fungal infection *  2/151 (1.32%)  2 0/48 (0.00%)  0
Fungal skin infection *  2/151 (1.32%)  2 0/48 (0.00%)  0
Furuncle *  0/151 (0.00%)  0 1/48 (2.08%)  1
Gastroenteritis *  4/151 (2.65%)  5 2/48 (4.17%)  2
Gastroenteritis viral *  6/151 (3.97%)  6 1/48 (2.08%)  1
Gastrointestinal infection *  0/151 (0.00%)  0 1/48 (2.08%)  1
Genital candidiasis *  2/151 (1.32%)  3 0/48 (0.00%)  0
Genital herpes *  1/151 (0.66%)  1 0/48 (0.00%)  0
Genital infection fungal *  1/151 (0.66%)  1 0/48 (0.00%)  0
Genitourinary tract gonococcal infection *  2/151 (1.32%)  2 0/48 (0.00%)  0
Gingivitis *  3/151 (1.99%)  3 1/48 (2.08%)  1
Groin abscess *  1/151 (0.66%)  1 0/48 (0.00%)  0
Herpes zoster *  0/151 (0.00%)  0 1/48 (2.08%)  1
Hordeolum *  1/151 (0.66%)  1 0/48 (0.00%)  0
Infected bite *  2/151 (1.32%)  2 0/48 (0.00%)  0
Infection parasitic *  2/151 (1.32%)  2 0/48 (0.00%)  0
Influenza *  10/151 (6.62%)  11 4/48 (8.33%)  5
Laryngitis bacterial *  1/151 (0.66%)  1 0/48 (0.00%)  0
Lower respiratory tract infection *  1/151 (0.66%)  1 0/48 (0.00%)  0
Malaria *  0/151 (0.00%)  0 1/48 (2.08%)  1
Mastoiditis *  1/151 (0.66%)  1 0/48 (0.00%)  0
Molluscum contagiosum *  1/151 (0.66%)  1 0/48 (0.00%)  0
Nasopharyngitis *  8/151 (5.30%)  8 4/48 (8.33%)  7
Oral herpes *  2/151 (1.32%)  2 1/48 (2.08%)  1
Oropharyngeal gonococcal infection *  1/151 (0.66%)  1 0/48 (0.00%)  0
Otitis externa *  1/151 (0.66%)  1 0/48 (0.00%)  0
Otitis media bacterial *  0/151 (0.00%)  0 1/48 (2.08%)  1
Paronychia *  0/151 (0.00%)  0 1/48 (2.08%)  1
Pelvic inflammatory disease *  2/151 (1.32%)  2 0/48 (0.00%)  0
Periorbital cellulitis *  1/151 (0.66%)  1 0/48 (0.00%)  0
Pharyngitis *  2/151 (1.32%)  2 0/48 (0.00%)  0
Pharyngitis bacterial *  3/151 (1.99%)  4 0/48 (0.00%)  0
Pneumonia bacterial *  0/151 (0.00%)  0 1/48 (2.08%)  1
Post procedural infection *  1/151 (0.66%)  2 0/48 (0.00%)  0
Postoperative wound infection *  1/151 (0.66%)  1 0/48 (0.00%)  0
Proctitis chlamydial *  1/151 (0.66%)  1 0/48 (0.00%)  0
Pyelonephritis *  1/151 (0.66%)  1 0/48 (0.00%)  0
Rhinitis *  3/151 (1.99%)  3 2/48 (4.17%)  2
Schistosomiasis *  1/151 (0.66%)  1 0/48 (0.00%)  0
Sinusitis *  5/151 (3.31%)  6 1/48 (2.08%)  1
Sinusitis bacterial *  2/151 (1.32%)  2 1/48 (2.08%)  1
Subcutaneous abscess *  2/151 (1.32%)  2 0/48 (0.00%)  0
Tinea cruris *  1/151 (0.66%)  1 0/48 (0.00%)  0
Tinea infection *  1/151 (0.66%)  1 1/48 (2.08%)  1
Tinea versicolour *  2/151 (1.32%)  2 0/48 (0.00%)  0
Tonsillitis *  3/151 (1.99%)  3 1/48 (2.08%)  1
Tonsillitis bacterial *  4/151 (2.65%)  4 1/48 (2.08%)  1
Tooth abscess *  1/151 (0.66%)  1 0/48 (0.00%)  0
Upper respiratory tract infection *  25/151 (16.56%)  41 11/48 (22.92%)  13
Upper respiratory tract infection bacterial *  10/151 (6.62%)  13 1/48 (2.08%)  1
Urethritis gonococcal *  1/151 (0.66%)  1 0/48 (0.00%)  0
Urinary tract infection *  9/151 (5.96%)  11 2/48 (4.17%)  2
Urinary tract infection bacterial *  7/151 (4.64%)  9 1/48 (2.08%)  1
Viral infection *  5/151 (3.31%)  5 2/48 (4.17%)  3
Viral pharyngitis *  5/151 (3.31%)  5 0/48 (0.00%)  0
Viral rhinitis *  6/151 (3.97%)  9 0/48 (0.00%)  0
Viral tonsillitis *  1/151 (0.66%)  2 0/48 (0.00%)  0
Viral upper respiratory tract infection *  16/151 (10.60%)  18 8/48 (16.67%)  10
Vulvovaginal candidiasis *  6/151 (3.97%)  6 1/48 (2.08%)  2
Vulvovaginal mycotic infection *  3/151 (1.99%)  4 0/48 (0.00%)  0
Vulvovaginitis *  0/151 (0.00%)  0 1/48 (2.08%)  1
Zika virus infection *  2/151 (1.32%)  2 1/48 (2.08%)  1
Injury, poisoning and procedural complications     
Arthropod bite *  2/151 (1.32%)  2 0/48 (0.00%)  0
Cartilage injury *  1/151 (0.66%)  1 0/48 (0.00%)  0
Chemical burn of skin *  1/151 (0.66%)  1 0/48 (0.00%)  0
Contusion *  6/151 (3.97%)  7 1/48 (2.08%)  1
Exposure to toxic agent *  1/151 (0.66%)  1 0/48 (0.00%)  0
Eye injury *  1/151 (0.66%)  1 0/48 (0.00%)  0
Heat illness *  0/151 (0.00%)  0 1/48 (2.08%)  1
Human bite *  1/151 (0.66%)  1 0/48 (0.00%)  0
Hypobarism *  0/151 (0.00%)  0 1/48 (2.08%)  1
Injection related reaction *  1/151 (0.66%)  1 0/48 (0.00%)  0
Injury *  0/151 (0.00%)  0 1/48 (2.08%)  1
Joint dislocation *  1/151 (0.66%)  1 0/48 (0.00%)  0
Joint injury *  2/151 (1.32%)  2 2/48 (4.17%)  2
Laceration *  1/151 (0.66%)  1 1/48 (2.08%)  1
Ligament sprain *  3/151 (1.99%)  3 1/48 (2.08%)  1
Limb injury *  3/151 (1.99%)  3 0/48 (0.00%)  0
Muscle strain *  2/151 (1.32%)  2 2/48 (4.17%)  2
Post lumbar puncture syndrome *  1/151 (0.66%)  1 0/48 (0.00%)  0
Post procedural contusion *  1/151 (0.66%)  1 0/48 (0.00%)  0
Post procedural haematoma *  0/151 (0.00%)  0 1/48 (2.08%)  1
Post procedural swelling *  1/151 (0.66%)  1 0/48 (0.00%)  0
Procedural headache *  0/151 (0.00%)  0 1/48 (2.08%)  1
Procedural pain *  4/151 (2.65%)  4 0/48 (0.00%)  0
Radius fracture *  1/151 (0.66%)  1 0/48 (0.00%)  0
Skin abrasion *  2/151 (1.32%)  4 0/48 (0.00%)  0
Soft tissue injury *  1/151 (0.66%)  2 0/48 (0.00%)  0
Tendon injury *  1/151 (0.66%)  1 0/48 (0.00%)  0
Tooth fracture *  1/151 (0.66%)  1 0/48 (0.00%)  0
Toxicity to various agents *  1/151 (0.66%)  1 0/48 (0.00%)  0
Investigations     
Alanine aminotransferase increased *  18/151 (11.92%)  26 5/48 (10.42%)  8
Amylase decreased *  1/151 (0.66%)  1 0/48 (0.00%)  0
Amylase increased *  18/151 (11.92%)  32 5/48 (10.42%)  10
Aspartate aminotransferase increased *  13/151 (8.61%)  18 3/48 (6.25%)  4
Bilirubin conjugated increased *  7/151 (4.64%)  10 1/48 (2.08%)  1
Blood alkaline phosphatase increased *  1/151 (0.66%)  1 1/48 (2.08%)  1
Blood bicarbonate decreased *  24/151 (15.89%)  43 10/48 (20.83%)  18
Blood bilirubin increased *  3/151 (1.99%)  5 3/48 (6.25%)  5
Blood calcium decreased *  9/151 (5.96%)  10 4/48 (8.33%)  8
Blood calcium increased *  5/151 (3.31%)  5 3/48 (6.25%)  3
Blood cholesterol increased *  5/151 (3.31%)  5 0/48 (0.00%)  0
Blood creatine phosphokinase increased *  25/151 (16.56%)  37 8/48 (16.67%)  14
Blood creatinine increased *  19/151 (12.58%)  33 4/48 (8.33%)  6
Blood glucose decreased *  29/151 (19.21%)  56 11/48 (22.92%)  19
Blood glucose increased *  56/151 (37.09%)  99 21/48 (43.75%)  39
Blood magnesium decreased *  18/151 (11.92%)  31 8/48 (16.67%)  11
Blood magnesium increased *  2/151 (1.32%)  2 0/48 (0.00%)  0
Blood phosphorus decreased *  25/151 (16.56%)  38 10/48 (20.83%)  17
Blood potassium decreased *  8/151 (5.30%)  11 1/48 (2.08%)  1
Blood potassium increased *  3/151 (1.99%)  3 0/48 (0.00%)  0
Blood pressure diastolic increased *  0/151 (0.00%)  0 1/48 (2.08%)  1
Blood pressure increased *  7/151 (4.64%)  9 1/48 (2.08%)  1
Blood pressure systolic increased *  0/151 (0.00%)  0 1/48 (2.08%)  1
Blood sodium decreased *  8/151 (5.30%)  9 1/48 (2.08%)  1
Blood sodium increased *  8/151 (5.30%)  11 3/48 (6.25%)  3
Blood triglycerides increased *  7/151 (4.64%)  7 1/48 (2.08%)  1
Carbon dioxide decreased *  8/151 (5.30%)  15 3/48 (6.25%)  5
Creatinine renal clearance decreased *  71/151 (47.02%)  168 21/48 (43.75%)  47
Electrocardiogram PR prolongation *  3/151 (1.99%)  4 1/48 (2.08%)  1
Electrocardiogram QT prolonged *  7/151 (4.64%)  13 3/48 (6.25%)  4
Electrocardiogram T wave inversion *  1/151 (0.66%)  1 1/48 (2.08%)  2
Electrocardiogram repolarisation abnormality *  1/151 (0.66%)  1 1/48 (2.08%)  1
Haemoglobin decreased *  6/151 (3.97%)  11 1/48 (2.08%)  3
Heart rate increased *  1/151 (0.66%)  1 0/48 (0.00%)  0
Lipase increased *  23/151 (15.23%)  34 14/48 (29.17%)  26
Low density lipoprotein increased *  9/151 (5.96%)  9 2/48 (4.17%)  2
Lymphocyte count decreased *  0/151 (0.00%)  0 1/48 (2.08%)  1
Neutrophil count decreased *  2/151 (1.32%)  3 1/48 (2.08%)  2
Platelet count decreased *  3/151 (1.99%)  3 1/48 (2.08%)  1
Protein urine *  1/151 (0.66%)  1 0/48 (0.00%)  0
Weight decreased *  2/151 (1.32%)  4 3/48 (6.25%)  4
White blood cell count decreased *  2/151 (1.32%)  2 0/48 (0.00%)  0
Metabolism and nutrition disorders     
Abnormal loss of weight *  4/151 (2.65%)  5 0/48 (0.00%)  0
Decreased appetite *  3/151 (1.99%)  3 1/48 (2.08%)  1
Diabetes mellitus *  1/151 (0.66%)  1 0/48 (0.00%)  0
Hypercholesterolaemia *  0/151 (0.00%)  0 1/48 (2.08%)  1
Hyperglycaemia *  4/151 (2.65%)  4 3/48 (6.25%)  3
Hypernatraemia *  2/151 (1.32%)  2 2/48 (4.17%)  2
Hyperphagia *  1/151 (0.66%)  1 0/48 (0.00%)  0
Hypocalcaemia *  1/151 (0.66%)  1 0/48 (0.00%)  0
Hypoglycaemia *  7/151 (4.64%)  12 1/48 (2.08%)  2
Hypokalaemia *  2/151 (1.32%)  3 1/48 (2.08%)  3
Hypomagnesaemia *  1/151 (0.66%)  2 0/48 (0.00%)  0
Hyponatraemia *  0/151 (0.00%)  0 2/48 (4.17%)  2
Hypophosphataemia *  6/151 (3.97%)  8 1/48 (2.08%)  2
Increased appetite *  3/151 (1.99%)  3 1/48 (2.08%)  1
Iron deficiency *  3/151 (1.99%)  4 0/48 (0.00%)  0
Metabolic syndrome *  1/151 (0.66%)  1 0/48 (0.00%)  0
Polydipsia *  1/151 (0.66%)  1 0/48 (0.00%)  0
Vitamin D deficiency *  2/151 (1.32%)  2 0/48 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia *  11/151 (7.28%)  13 3/48 (6.25%)  3
Arthritis *  1/151 (0.66%)  1 0/48 (0.00%)  0
Arthrofibrosis *  1/151 (0.66%)  1 0/48 (0.00%)  0
Back pain *  16/151 (10.60%)  18 3/48 (6.25%)  3
Costochondritis *  1/151 (0.66%)  1 0/48 (0.00%)  0
Exostosis *  0/151 (0.00%)  0 1/48 (2.08%)  1
Femoroacetabular impingement *  1/151 (0.66%)  1 0/48 (0.00%)  0
Intervertebral disc degeneration *  1/151 (0.66%)  1 0/48 (0.00%)  0
Joint stiffness *  1/151 (0.66%)  3 0/48 (0.00%)  0
Ligament laxity *  1/151 (0.66%)  1 0/48 (0.00%)  0
Muscle spasms *  1/151 (0.66%)  1 0/48 (0.00%)  0
Muscle tightness *  1/151 (0.66%)  1 0/48 (0.00%)  0
Muscle twitching *  1/151 (0.66%)  1 1/48 (2.08%)  2
Muscular weakness *  0/151 (0.00%)  0 1/48 (2.08%)  1
Musculoskeletal chest pain *  1/151 (0.66%)  1 0/48 (0.00%)  0
Musculoskeletal discomfort *  1/151 (0.66%)  2 0/48 (0.00%)  0
Musculoskeletal pain *  13/151 (8.61%)  14 4/48 (8.33%)  5
Musculoskeletal stiffness *  1/151 (0.66%)  1 0/48 (0.00%)  0
Myalgia *  16/151 (10.60%)  19 4/48 (8.33%)  7
Neck pain *  8/151 (5.30%)  8 0/48 (0.00%)  0
Pain in extremity *  10/151 (6.62%)  10 2/48 (4.17%)  2
Patellofemoral pain syndrome *  0/151 (0.00%)  0 1/48 (2.08%)  1
Plantar fasciitis *  1/151 (0.66%)  1 0/48 (0.00%)  0
Rotator cuff syndrome *  1/151 (0.66%)  1 0/48 (0.00%)  0
Spondylitis *  0/151 (0.00%)  0 1/48 (2.08%)  1
Synovial cyst *  0/151 (0.00%)  0 1/48 (2.08%)  1
Synovitis *  0/151 (0.00%)  0 1/48 (2.08%)  1
Tendon pain *  0/151 (0.00%)  0 1/48 (2.08%)  1
Tendonitis *  2/151 (1.32%)  2 0/48 (0.00%)  0
Tenosynovitis stenosans *  1/151 (0.66%)  1 0/48 (0.00%)  0
Torticollis *  1/151 (0.66%)  1 0/48 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma *  1/151 (0.66%)  2 0/48 (0.00%)  0
Dysplastic naevus *  0/151 (0.00%)  0 1/48 (2.08%)  1
Nervous system disorders     
Disturbance in attention *  2/151 (1.32%)  2 2/48 (4.17%)  2
Dizziness *  22/151 (14.57%)  28 5/48 (10.42%)  6
Dysgeusia *  1/151 (0.66%)  1 0/48 (0.00%)  0
Facial paralysis *  1/151 (0.66%)  1 0/48 (0.00%)  0
Headache *  53/151 (35.10%)  78 11/48 (22.92%)  13
Hypersomnia *  2/151 (1.32%)  2 0/48 (0.00%)  0
Hypoaesthesia *  7/151 (4.64%)  10 1/48 (2.08%)  1
Intracranial pressure increased *  1/151 (0.66%)  1 0/48 (0.00%)  0
Lumbar radiculopathy *  0/151 (0.00%)  0 1/48 (2.08%)  1
Migraine *  1/151 (0.66%)  1 1/48 (2.08%)  1
Nerve compression *  1/151 (0.66%)  1 0/48 (0.00%)  0
Paraesthesia *  7/151 (4.64%)  9 1/48 (2.08%)  1
Presyncope *  1/151 (0.66%)  1 0/48 (0.00%)  0
Seizure *  1/151 (0.66%)  1 0/48 (0.00%)  0
Somnolence *  3/151 (1.99%)  3 1/48 (2.08%)  1
Spinal cord compression *  1/151 (0.66%)  1 0/48 (0.00%)  0
Tension headache *  1/151 (0.66%)  1 1/48 (2.08%)  1
Tremor *  1/151 (0.66%)  1 0/48 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Vomiting in pregnancy *  0/151 (0.00%)  0 1/48 (2.08%)  1
Product Issues     
Device breakage *  1/151 (0.66%)  1 0/48 (0.00%)  0
Psychiatric disorders     
Abnormal dreams *  8/151 (5.30%)  12 4/48 (8.33%)  4
Anxiety *  4/151 (2.65%)  4 1/48 (2.08%)  1
Anxiety disorder *  0/151 (0.00%)  0 1/48 (2.08%)  1
Depressed mood *  1/151 (0.66%)  1 1/48 (2.08%)  1
Depression *  0/151 (0.00%)  0 3/48 (6.25%)  3
Initial insomnia *  0/151 (0.00%)  0 1/48 (2.08%)  1
Insomnia *  13/151 (8.61%)  18 2/48 (4.17%)  2
Irritability *  1/151 (0.66%)  1 0/48 (0.00%)  0
Libido decreased *  1/151 (0.66%)  1 0/48 (0.00%)  0
Mood altered *  1/151 (0.66%)  1 0/48 (0.00%)  0
Mood swings *  1/151 (0.66%)  1 0/48 (0.00%)  0
Sleep disorder *  1/151 (0.66%)  1 1/48 (2.08%)  1
Stress *  1/151 (0.66%)  1 0/48 (0.00%)  0
Renal and urinary disorders     
Dysuria *  1/151 (0.66%)  1 0/48 (0.00%)  0
Polyuria *  2/151 (1.32%)  2 0/48 (0.00%)  0
Proteinuria *  5/151 (3.31%)  5 0/48 (0.00%)  0
Urinary hesitation *  0/151 (0.00%)  0 1/48 (2.08%)  1
Urinary incontinence *  0/151 (0.00%)  0 1/48 (2.08%)  1
Reproductive system and breast disorders     
Balanoposthitis *  1/151 (0.66%)  1 0/48 (0.00%)  0
Breast mass *  2/151 (1.32%)  2 0/48 (0.00%)  0
Cervical dysplasia *  1/151 (0.66%)  1 1/48 (2.08%)  1
Dysfunctional uterine bleeding *  4/151 (2.65%)  4 2/48 (4.17%)  2
Dysmenorrhoea *  3/151 (1.99%)  3 0/48 (0.00%)  0
Dyspareunia *  1/151 (0.66%)  1 0/48 (0.00%)  0
Menorrhagia *  2/151 (1.32%)  3 0/48 (0.00%)  0
Metrorrhagia *  1/151 (0.66%)  2 0/48 (0.00%)  0
Oligomenorrhoea *  1/151 (0.66%)  1 0/48 (0.00%)  0
Ovarian cyst *  1/151 (0.66%)  1 0/48 (0.00%)  0
Testicular swelling *  0/151 (0.00%)  0 1/48 (2.08%)  1
Uterine haemorrhage *  0/151 (0.00%)  0 1/48 (2.08%)  1
Vaginal discharge *  5/151 (3.31%)  5 0/48 (0.00%)  0
Vulvovaginal pruritus *  2/151 (1.32%)  2 0/48 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Allergic pharyngitis *  1/151 (0.66%)  1 0/48 (0.00%)  0
Allergic sinusitis *  3/151 (1.99%)  3 0/48 (0.00%)  0
Cough *  6/151 (3.97%)  6 0/48 (0.00%)  0
Epistaxis *  2/151 (1.32%)  2 0/48 (0.00%)  0
Nasal congestion *  8/151 (5.30%)  8 4/48 (8.33%)  4
Nasal inflammation *  0/151 (0.00%)  0 1/48 (2.08%)  2
Nasal polyps *  1/151 (0.66%)  1 0/48 (0.00%)  0
Oropharyngeal pain *  5/151 (3.31%)  5 1/48 (2.08%)  1
Pharyngeal erythema *  1/151 (0.66%)  1 0/48 (0.00%)  0
Pharyngeal exudate *  1/151 (0.66%)  1 0/48 (0.00%)  0
Rhinitis allergic *  4/151 (2.65%)  5 1/48 (2.08%)  1
Rhinorrhoea *  2/151 (1.32%)  2 0/48 (0.00%)  0
Sinus congestion *  1/151 (0.66%)  1 0/48 (0.00%)  0
Sinus pain *  2/151 (1.32%)  2 0/48 (0.00%)  0
Sneezing *  1/151 (0.66%)  1 1/48 (2.08%)  1
Throat irritation *  1/151 (0.66%)  1 0/48 (0.00%)  0
Upper-airway cough syndrome *  0/151 (0.00%)  0 1/48 (2.08%)  1
Skin and subcutaneous tissue disorders     
Acne *  3/151 (1.99%)  3 1/48 (2.08%)  1
Angioedema *  2/151 (1.32%)  2 0/48 (0.00%)  0
Blister *  1/151 (0.66%)  1 0/48 (0.00%)  0
Dermatitis *  3/151 (1.99%)  3 2/48 (4.17%)  2
Dermatitis allergic *  2/151 (1.32%)  2 0/48 (0.00%)  0
Dermatitis atopic *  2/151 (1.32%)  2 0/48 (0.00%)  0
Dermatitis contact *  4/151 (2.65%)  5 0/48 (0.00%)  0
Dry skin *  2/151 (1.32%)  2 0/48 (0.00%)  0
Eczema *  2/151 (1.32%)  2 0/48 (0.00%)  0
Erythema *  2/151 (1.32%)  2 2/48 (4.17%)  3
Hyperhidrosis *  2/151 (1.32%)  2 0/48 (0.00%)  0
Intertrigo *  1/151 (0.66%)  1 0/48 (0.00%)  0
Papule *  2/151 (1.32%)  2 1/48 (2.08%)  1
Penile ulceration *  1/151 (0.66%)  1 0/48 (0.00%)  0
Photosensitivity reaction *  1/151 (0.66%)  1 0/48 (0.00%)  0
Pruritus *  4/151 (2.65%)  4 1/48 (2.08%)  1
Pruritus generalised *  3/151 (1.99%)  4 0/48 (0.00%)  0
Rash *  4/151 (2.65%)  4 1/48 (2.08%)  1
Rash erythematous *  0/151 (0.00%)  0 1/48 (2.08%)  2
Rash macular *  1/151 (0.66%)  1 0/48 (0.00%)  0
Rash maculo-papular *  3/151 (1.99%)  3 0/48 (0.00%)  0
Rash papular *  1/151 (0.66%)  1 0/48 (0.00%)  0
Rash pruritic *  3/151 (1.99%)  3 0/48 (0.00%)  0
Seborrhoea *  1/151 (0.66%)  1 0/48 (0.00%)  0
Skin erosion *  1/151 (0.66%)  1 0/48 (0.00%)  0
Skin odour abnormal *  1/151 (0.66%)  1 0/48 (0.00%)  0
Urticaria *  4/151 (2.65%)  8 2/48 (4.17%)  2
Urticaria papular *  2/151 (1.32%)  2 0/48 (0.00%)  0
Vascular disorders     
Essential hypertension *  1/151 (0.66%)  3 0/48 (0.00%)  0
Hypertension *  8/151 (5.30%)  8 0/48 (0.00%)  0
Orthostatic hypotension *  2/151 (1.32%)  2 0/48 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gordon Chau
Organization: Fred Hutch Cancer Research Center
Phone: 2066672118
EMail: gchau@fredhutch.org
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02178800    
Other Study ID Numbers: HPTN 077
11964 ( Registry Identifier: DAIDS ES )
First Submitted: June 27, 2014
First Posted: July 1, 2014
Results First Submitted: April 30, 2018
Results First Posted: July 5, 2018
Last Update Posted: March 13, 2020