Study to Evaluate the Safety Tolerability and Acceptability of Long Acting Injections of the Human Immunodeficiency Virus (HIV) Integrase Inhibitor, GSK1265744, in HIV Uninfected Men (ECLAIR)
CompletedPhase 2Results postedLast updated 15 December 2017
What this trial tests
Phase 2 trial testing 744 Tablet in Infection, Human Immunodeficiency Virus in 127 participants. Completed in 23 February 2016.
Adults 18 to 65, male only, with Infection, Human Immunodeficiency Virus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Any Grade 2 or Higher Event in the Injection PhasePrimary· Up to Week 41
Clinical adverse event (AE) were graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) table for grading the severity of adult and pediatric AE Version 1.0, December 2004; Clarification August 2009. The grades were: 1 (mild)=Symptoms causing no or minimal interference with usual social and functional activities; 2 (moderate)= Symptoms causing greater than minimal interference with usual social and functional activities; 3 (severe)= Symptoms causing inability to perform usual social and functional activities; 4 (potentially life threatening): Symptoms causing inability to perf
Group
Value
95% CI
Placebo
10
Cabotegravir
75
Number of Participants Who Recieved Injection Site Reaction (ISR) Related Concomitant Medication in the Injection PhasePrimary· Up to Week 41
The concurrent medications that were consumed by participants during the injection phase were of the class nervous system, musculo-skeletal system, genito urinary systems and sex hormones, various, respiratory system, dermatologicals, alimentary tract and metabolism, sensory organs, systemic hormonal preparations, excluding sex hormones, blood and blood forming organs, cardiovascular system. The participants who took medication from any of the above class of during the injection phase (Week 5-Week 41) have been presented.
Group
Value
95% CI
Placebo
5
Cabotegravir
55
Number of Participants Who Experienced Grade 2 or Higher Laboratory Results in the Injection PhasePrimary· Up to Week 41
The severity of laboratory results was graded according to the DAIDS table for grading the severity of adult and pediatric AE Version 1.0, December 2004; Clarification August 2009. The DAIDS displays events as Grades 1-5 based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening. Data for Number of participants who experienced grade 2 or higher laboratory results in the injection phase (Week 5-Week 14) have been presented.
Activated prothrombin time/standard
Group
Value
95% CI
Placebo
1
Cabotegravir
0
Activated partial thromboplastin time
Group
Value
95% CI
Placebo
1
Cabotegravir
0
Alanine aminotransferase
Group
Value
95% CI
Placebo
0
Cabotegravir
2
Aspartate aminotransferase
Group
Value
95% CI
Placebo
0
Cabotegravir
2
Bilirubin
Group
Value
95% CI
Placebo
0
Cabotegravir
4
Carbon dioxide
Group
Value
95% CI
Placebo
0
Cabotegravir
1
Cholesterol
Group
Value
95% CI
Placebo
1
Cabotegravir
4
Creatine kinase
Group
Value
95% CI
Placebo
3
Cabotegravir
6
Number of Participants Who Had Abnormal Electrocardiogram (ECG) Findings in the Injection PhasePrimary· Up to Week 41
Full 12-lead ECGs included heart rate, PR, QRS, QT and QTc intervals. Measurements were taken from the participant following 5 minutes of rest in a semi-supine position. ECGs were performed at Week 5, Week 17, Week 29 and Week 41 in the injection phase (Week 5-Week 41). ECG abnormalities characterized as abnormal-not clinically significant (A-NCS) and abnormal-clinically significant (A-CS) upto Week 41 have been presented. There were no A-CS findings for ECG in the injection phase.
Week 5, A-NCS
Group
Value
95% CI
Placebo
6
Cabotegravir
30
Week 17, A-NCS
Group
Value
95% CI
Placebo
9
Cabotegravir
34
Week 29, A-NCS
Group
Value
95% CI
Placebo
7
Cabotegravir
27
Week 41, A-NCS
Group
Value
95% CI
Placebo
5
Cabotegravir
23
Change From Baseline in Vital Sign Assessment for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in the Injection PhasePrimary· Baseline (Week 5) to Week 41
Vital signs measurements were performed for SBP and DBP following 5 minutes of rest. Baseline was defined as the first injection at Week 5 for the injection phase. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value at Week 17, Week 29 and Week 41.
Week 17, DBP
Group
Value
95% CI
Placebo
-3.10
± 11.541
Cabotegravir
-0.74
± 7.214
Week 29, DBP
Group
Value
95% CI
Placebo
-3.75
± 12.781
Cabotegravir
0.32
± 8.283
Week 41, DBP
Group
Value
95% CI
Placebo
-1.19
± 13.692
Cabotegravir
0.01
± 9.286
Week 17, SBP
Group
Value
95% CI
Placebo
-1.52
± 14.041
Cabotegravir
-0.66
± 9.237
Week 29, SBP
Group
Value
95% CI
Placebo
2.80
± 10.904
Cabotegravir
2.62
± 10.868
Week 41, SBP,
Group
Value
95% CI
Placebo
-1.38
± 14.044
Cabotegravir
1.64
± 12.012
Change From Baseline in Vital Sign Assessment for Heart Rate (HR) in the Injection PhasePrimary· Baseline (Week 5) to Week 41
Vital signs measurements were performed for HR following 5 minutes of rest. Baseline was defined as the first injection at Week 5 for the injection phase. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value at Week 17, Week 29 and Week 41.
Week 17, HR
Group
Value
95% CI
Placebo
1.19
± 11.021
Cabotegravir
3.26
± 11.684
Week 29, HR
Group
Value
95% CI
Placebo
1.55
± 10.149
Cabotegravir
4.06
± 10.740
Week 41, HR
Group
Value
95% CI
Placebo
1.43
± 10.181
Cabotegravir
2.73
± 11.752
Number of Participant With ISR for the Injection Phase Defined by Maximum GradesPrimary· Up to Week 41
Common ISR included pain, erythema, nodules and any other ISR with greater or equal to 5 participants. The number of participants who experienced pain events by needle length, swelling events by needle length, bump events by needle length for injection phase by maximum grades have been presented for the injection phase (Week 5-Week 41).
ISR pain, Grade 1
Group
Value
95% CI
Placebo
11
Cabotegravir
31
ISR pain, Grade 2
Group
Value
95% CI
Placebo
1
Cabotegravir
37
ISR pain, Grade 3
Group
Value
95% CI
Placebo
0
Cabotegravir
18
ISR pain, Grade 4
Group
Value
95% CI
Placebo
0
Cabotegravir
0
ISR swelling, Grade 1
Group
Value
95% CI
Placebo
0
Cabotegravir
11
ISR swelling, Grade 2
Group
Value
95% CI
Placebo
0
Cabotegravir
4
ISR swelling, Grade 3
Group
Value
95% CI
Placebo
0
Cabotegravir
0
ISR swelling, Grade 4
Group
Value
95% CI
Placebo
0
Cabotegravir
0
Plasma Pharmacokinetic Assessment for Area Under the Plasma Concentration-time Curve Over the Dosing Interval [AUC(0-tau)] in the Injection PhaseSecondary· Up to Week 41
Blood samples for pharmacokinetic analysis were collected starting on the first day of the First Injection Phase prior to the injection. At each injection visit a blood sample was collected prior to the injection at Week 5, Week 17 and Week 29, 1 Week post-injection at Week 6, Week 18, and Week 30, and 12 Week post-injection at Week 17, Week 29, and Week 41. The sample collected 12 Week following each injection served as the pre-dose sample for the subsequent dosing interval. Two additional samples were collected 4 and 8 Week after the first injection (Week 9 and Week 13), and 1 additional sam
Injection 1
Group
Value
95% CI
Cabotegravir
3414.71
± 42.5
Injection 2
Group
Value
95% CI
Cabotegravir
3873.25
± 44.3
Injection 3
Group
Value
95% CI
Cabotegravir
4020.89
± 36.2
Plasma Pharmacokinetic Assessment for Concentration at the End of the Dosing Interval (Ctau) and Maximum Observed Concentration (Cmax) in the Injection PhaseSecondary· Up to Week 41
Blood samples for pharmacokinetic analysis were collected starting on the first day of the First Injection Phase prior to the injection. At each injection visit a blood sample was collected prior to the injection at Week 5, Week 17 and Week 29, 1 Week post-injection at Week 6, Week 18, and Week 30, and 12 Week post-injection at Week 17, Week 29, and Week 41. The sample collected 12 Week following each injection served as the pre-dose sample for the subsequent dosing interval. Two additional samples were collected 4 and 8 Week after the first injection (Week 9 and Week 13), and 1 additional sam
Cmax, Injection 1
Group
Value
95% CI
Cabotegravir
4.26
± 88.6
Cmax, Injection 2
Group
Value
95% CI
Cabotegravir
5.22
± 78.0
Cmax, Injection 3
Group
Value
95% CI
Cabotegravir
4.91
± 66.6
Ctau, Injection 1
Group
Value
95% CI
Cabotegravir
0.302
± 157.1
Ctau, Injection 2
Group
Value
95% CI
Cabotegravir
0.331
± 164.5
Ctau, Injection 3
Group
Value
95% CI
Cabotegravir
0.387
± 149.6
Plasma Pharmacokinetic Assessment for Time to Maximum Observed Concentration (Tmax), Apparent Terminal Phase Half-life for (t½) in the Injection PhaseSecondary· Up to Week 41
Blood samples for pharmacokinetic analysis were collected starting on the first day of the First Injection Phase prior to the injection. At each injection visit a blood sample was collected prior to the injection at Week 5, Week 17 and Week 29, 1 Week post-injection at Week 6, Week 18, and Week 30, and 12 Week post-injection at Week 17, Week 29, and Week 41. The sample collected 12 Week following each injection served as the pre-dose sample for the subsequent dosing interval. Two additional samples were collected 4 and 8 Week after the first injection (Week 9 and Week 13), and 1 additional sam
tmax, Injection 1
Group
Value
95% CI
Cabotegravir
13.14
± 11.503
tmax, Injection 2
Group
Value
95% CI
Cabotegravir
8.91
± 9.311
tmax, Injection 3
Group
Value
95% CI
Cabotegravir
9.25
± 7.579
t½ , Injection 1
Group
Value
95% CI
Cabotegravir
20.54
± 10.690
Plasma Pharmacokinetic Assessment for AUC(0-tau) by Demographic Factor Body Mass Index (BMI) and Needle Length in the Injection PhaseSecondary· Up to Week 41
The median BMI was 26 kilogram per meter square. Plasma pharmacokinetic assessments were performed for AUC (0-tau) by BMI, either above or below the median BMI (50 percent upper and lower, where upper summary included all participants with BMI greater than or equal to the median BMI of the population and lower summary included all participants with BMI below the median BMI). Assessments was also performed for AUC (0-tau) by needle length (1.5 inch and 2 inch). Needle length and BMI were correlated in that the longer needle was recommended for participants with BMI greater than 30 kilogram per
50 percent BMI lower, Injection 1
Group
Value
95% CI
Cabotegravir
4103.71
± 28.4
50 percent BMI lower, Injection 2
Group
Value
95% CI
Cabotegravir
4250.82
± 49.6
50 percent BMI lower, Injection 3
Group
Value
95% CI
Cabotegravir
4847.07
± 26.1
50 percent BMI upper, Injection 1
Group
Value
95% CI
Cabotegravir
2830.06
± 45.6
50 percent BMI upper, Injection 2
Group
Value
95% CI
Cabotegravir
3536.52
± 36.7
50 percent BMI upper, Injection 3
Group
Value
95% CI
Cabotegravir
3405.52
± 35.2
1.5 inch Injection 1
Group
Value
95% CI
Cabotegravir
3666.95
± 40.0
1.5 inch Injection 2
Group
Value
95% CI
Cabotegravir
4177.42
± 44.0
Plasma Pharmacokinetic Assessment for Ctau and Cmax by Demographic Factor BMI and Needle Length in the Injection PhaseSecondary· Up to Week 41
The median BMI was 26 kilogram per meter square. Plasma pharmacokinetic assessments were performed for Ctau and Cmax by BMI, either above or below the median BMI (50 percent upper and lower, where upper summary included all participants with BMI greater than or equal to the median BMI of the population and lower summary included all participants with BMI below the median BMI.
). Assessments was also performed for Ctau and Cmax by needle length (1.5 inch and 2 inch). Needle length and BMI were correlated in that the longer needle was recommended for participants with BMI greater than 30 kilogr
50 percent BMI lower for Cmax, Injection 1
Group
Value
95% CI
Cabotegravir
6.02
± 51.3
50 percent BMI lower for Cmax, Injection 2
Group
Value
95% CI
Cabotegravir
6.65
± 54.8
50 percent BMI lower for Cmax, Injection 3
Group
Value
95% CI
Cabotegravir
6.99
± 35.9
50 percent BMI lower for Ctau, Injection 1
Group
Value
95% CI
Cabotegravir
0.226
± 159.9
50 percent BMI lower for Ctau, Injection 2
Group
Value
95% CI
Cabotegravir
0.312
± 138.3
50 percent BMI lower for Ctau, Injection 3
Group
Value
95% CI
Cabotegravir
0.334
± 102.2
50 percent BMI upper for Cmax, Injection 1
Group
Value
95% CI
Cabotegravir
2.99
± 100.0
50 percent BMI upper for Cmax, Injection 2
Group
Value
95% CI
Cabotegravir
4.12
± 88.4
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to Week 41.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study is a Phase IIa, randomized, multi-site, two-arm, double-blinded study to evaluate the safety, tolerability, and acceptability of GSK1265744 long acting injectable formulation (744 LA) in adult male subjects. To evaluate the safety and tolerability of the injectable agent, 744 LA (800 milligrams (mg) dose administered at three time points at 12 week intervals) through Week 41 in HIV-uninfected men. Eligible participants will be randomized in a 5:1 ratio to receive 744 LA or matching placebo. Participants will receive daily oral 744 (30 mg tablets) or matching placebo for 4 weeks during the Oral Phase of the study, followed by a one week washout period. Following safety lab assessments from the Oral Phase, participants will enter the Injection Phase and receive Intramuscular (IM) injections of 744 LA or placebo at three time points at 12 week intervals. IM injections will consist of 800 mg of 744 or a matching control
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ViiV Healthcare
Last refreshed: 15 December 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02076178.