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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02076178
First Posted: March 3, 2014
Last Update Posted: December 15, 2017
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.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
Results First Submitted: September 28, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Infection, Human Immunodeficiency Virus
Interventions: Drug: 744 Tablet
Drug: 744 LA Injection
Drug: Placebo Tablet
Drug: Placebo Injection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted at 10 centers in United states. Participants who received study medication are being followed for 52 Weeks following their last injection while those in placebo group were followed until all participants completed Week 41. The first subject’s first visit was 27-Mar-2014 and the last subject’s last visit was 15-May-2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 205 participants were screened of which 78 participants were not randomized. The remaining 127 participants were randomized to the study treatment who entered the oral and injection phase. Out of this, one participant randomized but withdrawn consent prior to treatment.

Reporting Groups
  Description
Placebo Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received intramuscular (IM) injection of placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injection consisted of 800 mg of placebo.
Cabotegravir Eligible participants received daily oral cabotegravir 30 milligrams (mg) tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir.

Participant Flow for 2 periods

Period 1:   Oral Phase
    Placebo   Cabotegravir
STARTED   21   106 
COMPLETED   21   94 
NOT COMPLETED   0   12 
Adverse Event                0                7 
Withdrawal by Subject                0                4 
Physician Decision                0                1 

Period 2:   Injection Phase
    Placebo   Cabotegravir
STARTED   21   94 
COMPLETED   20   87 
NOT COMPLETED   1   7 
Protocol defined stopping criteria                1                0 
Withdrawal by Subject                0                3 
Physician Decision                0                3 
Lost to Follow-up                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Eligible participants received matching placebo tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving matching placebo injections [0.9 percent saline]. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injection of placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injection consisted of 800 mg of placebo.
Cabotegravir Eligible participants received daily oral cabotegravir 30 mg tablets for 4 Week during the Oral Phase of the study, followed by a 1 Week washout period, to assess for safety and tolerability prior to receiving cabotegravir injections. Following safety laboratory assessments from the Oral Phase, participants entered the Injection Phase and received IM injections of cabotegravir or placebo at 3 time points at 12 Week intervals (Week 5, Week 17, and Week 29). The IM injections consisted of 800 mg of cabotegravir.
Total Total of all reporting groups

Baseline Measures
   Placebo   Cabotegravir   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   106   127 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 21   105   126 
   33.7  (11.56)   35.1  (11.75)   34.9  (11.68) 
[1] One participant randomized but withdrawn consent prior to treatment and not included in analysis for Age, continuous.
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 21   106   127 
Female      0   0.0%      0   0.0%      0   0.0% 
Male      21 100.0%      106 100.0%      127 100.0% 
Race/Ethnicity, Customized 
[Units: Participants]
     
African American/African Heritage       
Participants Analyzed 
[Units: Participants]
 21   106   127 
African American/African Heritage   7   33   40 
American Indian or Alaska Native       
Participants Analyzed 
[Units: Participants]
 21   106   127 
American Indian or Alaska Native   0   3   3 
Asian - Central/South Asian Heritage       
Participants Analyzed 
[Units: Participants]
 21   106   127 
Asian - Central/South Asian Heritage   1   2   3 
Asian - East Asian Heritage       
Participants Analyzed 
[Units: Participants]
 21   106   127 
Asian - East Asian Heritage   1   2   3 
Asian - South East Asian Heritage       
Participants Analyzed 
[Units: Participants]
 21   106   127 
Asian - South East Asian Heritage   0   1   1 
Native Hawaiian or other Pacific Islander       
Participants Analyzed 
[Units: Participants]
 21   106   127 
Native Hawaiian or other Pacific Islander   0   1   1 
White - Arabic/North African Heritage       
Participants Analyzed 
[Units: Participants]
 21   106   127 
White - Arabic/North African Heritage   0   3   3 
White - White/Caucasian/European Heritage       
Participants Analyzed 
[Units: Participants]
 21   106   127 
White - White/Caucasian/European Heritage   12   59   71 
Unknown       
Participants Analyzed 
[Units: Participants]
 21   106   127 
Unknown   0   2   2 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Any Grade 2 or Higher Event in the Injection Phase   [ Time Frame: Up to Week 41 ]

2.  Primary:   Number of Participants Who Recieved Injection Site Reaction (ISR) Related Concomitant Medication in the Injection Phase   [ Time Frame: Up to Week 41 ]

3.  Primary:   Number of Participants Who Experienced Grade 2 or Higher Laboratory Results in the Injection Phase   [ Time Frame: Up to Week 41 ]

4.  Primary:   Number of Participants Who Had Abnormal Electrocardiogram (ECG) Findings in the Injection Phase   [ Time Frame: Up to Week 41 ]

5.  Primary:   Change From Baseline in Vital Sign Assessment for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in the Injection Phase   [ Time Frame: Baseline (Week 5) to Week 41 ]

6.  Primary:   Change From Baseline in Vital Sign Assessment for Heart Rate (HR) in the Injection Phase   [ Time Frame: Baseline (Week 5) to Week 41 ]

7.  Primary:   Number of Participant With ISR for the Injection Phase Defined by Maximum Grades   [ Time Frame: Up to Week 41 ]

8.  Secondary:   Plasma Pharmacokinetic Assessment for Area Under the Plasma Concentration-time Curve Over the Dosing Interval [AUC(0-tau)] in the Injection Phase   [ Time Frame: Up to Week 41 ]

9.  Secondary:   Plasma Pharmacokinetic Assessment for Concentration at the End of the Dosing Interval (Ctau) and Maximum Observed Concentration (Cmax) in the Injection Phase   [ Time Frame: Up to Week 41 ]

10.  Secondary:   Plasma Pharmacokinetic Assessment for Time to Maximum Observed Concentration (Tmax), Apparent Terminal Phase Half-life for (t½) in the Injection Phase   [ Time Frame: Up to Week 41 ]

11.  Secondary:   Plasma Pharmacokinetic Assessment for AUC(0-tau) by Demographic Factor Body Mass Index (BMI) and Needle Length in the Injection Phase   [ Time Frame: Up to Week 41 ]

12.  Secondary:   Plasma Pharmacokinetic Assessment for Ctau and Cmax by Demographic Factor BMI and Needle Length in the Injection Phase   [ Time Frame: Up to Week 41 ]

13.  Secondary:   Plasma Pharmacokinetic Assessment for Tmax and t½ by Demographic Factor BMI and Needle Length in the Injection Phase   [ Time Frame: Up to Week 41 ]

14.  Secondary:   Number of Participants With Severity of ISRs and ISR Symptoms for Injection Phase Defined by Grades and Needle Length   [ Time Frame: Up to Week 41 ]

15.  Secondary:   Number of Participants With AE, Grade 2-4 AE and Serious Adverse Events (SAE) in the Oral Phase   [ Time Frame: Up to Week 4 ]

16.  Secondary:   Number of Participants Who Received Concurrent Medication in Overall Study Duration   [ Time Frame: Up to Week 41 ]

17.  Secondary:   Number of Participants Who Experienced Maximum Clinical Chemistry Including Liver Chemistry and Hematology Toxicities in the Oral Phase by Grades   [ Time Frame: Up to Week 4 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The results are presented till Week 41 with cutoff date 15-May-2015.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343



Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT02076178     History of Changes
Other Study ID Numbers: 201120
First Submitted: February 27, 2014
First Posted: March 3, 2014
Results First Submitted: September 28, 2017
Results First Posted: December 15, 2017
Last Update Posted: December 15, 2017