Phase IIa Dose-ranging Study of GSK1349572 in HIV-1 Infected Adults

This study has been completed.
Sponsor:
Collaborators:
Shionogi
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00708110
First received: June 30, 2008
Last updated: November 7, 2013
Last verified: August 2013
Results First Received: August 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Infection, Human Immunodeficiency Virus
Interventions: Drug: GSK1349572
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
GSK1349572 2 mg QD Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
GSK1349572 10 mg QD Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
GSK1349572 50 mg QD Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.

Participant Flow:   Overall Study
    Placebo     GSK1349572 2 mg QD     GSK1349572 10 mg QD     GSK1349572 50 mg QD  
STARTED     7     9     9     10  
COMPLETED     7     9     9     10  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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 Participants received matching placebo tablets orally once daily (QD) for 10 days and were followed for up to 21 days.
GSK1349572 2 mg QD Participants received GSK1349572 2 milligram (mg) tablets orally QD for 10 days and were followed for up to 21 days.
GSK1349572 10 mg QD Participants received GSK1349572 10 mg tablets orally QD for 10 days and were followed for up to 21 days.
GSK1349572 50 mg QD Participants received GSK1349572 50 mg tablets orally QD for 10 days and were followed for up to 21 days.
Total Total of all reporting groups

Baseline Measures
    Placebo     GSK1349572 2 mg QD     GSK1349572 10 mg QD     GSK1349572 50 mg QD     Total  
Number of Participants  
[units: participants]
  7     9     9     10     35  
Age  
[units: Years]
Mean ± Standard Deviation
  39.6  ± 10.64     41.1  ± 10.47     39.9  ± 4.14     33.7  ± 10.45     38.4  ± 9.38  
Gender  
[units: Participants]
         
Female     0     0     0     0     0  
Male     7     9     9     10     35  
Race/Ethnicity, Customized  
[units: participants]
         
African American/African Heritage     2     2     0     3     7  
White – White/Caucasian/European Heritage     5     7     9     7     28  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Day 11   [ Time Frame: Baseline (Day 1) and Day 11 ]

2.  Primary:   Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) and Over 24 Hours (AUC[0-24]) of GSK1349572 Following Dose Administration on Day 1   [ Time Frame: Day 1 ]

3.  Primary:   Maximum Observed Plasma Concentration (Cmax) and Concentration at 24 Hours Post Dose (C24) of GSK1349572 Following Dose Administration on Day 1   [ Time Frame: Day 1 ]

4.  Primary:   Time to Maximum Observed Concentration (Tmax) and Absorption Lag Time (Tlag) of GSK1349572 Following Dose Administration on Day 1   [ Time Frame: Day 1 ]

5.  Primary:   Terminal Half-life (t1/2) of GSK1349572 Following Dose Administration on Day 1   [ Time Frame: Day 1 ]

6.  Primary:   Apparent Clearance (CL/F) of GSK1349572 Following Dose Administration on Day 1   [ Time Frame: Day 1 ]

7.  Primary:   Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) of GSK1349572 Following the Last Repeat Administration on Day 10   [ Time Frame: Day 10 ]

8.  Primary:   Pre-dose Concentration (C0), Concentration at the End of the Dosing Interval (Ctau), Minimum Observed Concentration During One Dosing Interval (Cmin), and Maximum Obsevered Plasma Concentration (Cmax) of GSK1349572 Following the Last Repeat Administration   [ Time Frame: Day 10 ]

9.  Primary:   Time to the Maximum Observed Concentration (Tmax) of GSK1349572 Following the Last Repeat Administration on Day 10   [ Time Frame: Day 10 ]

10.  Primary:   Terminal Half-life (t1/2) of GSK1349572 Following the Last Repeat Administration on Day 10   [ Time Frame: Day 10 ]

11.  Primary:   Apparent Clearance (CL/F) of GSK1349572 Following Dose Administration on Day 10   [ Time Frame: Day 10 ]

12.  Primary:   Number of Participants With Any Non-serious Adverse Event (AE) or Serious Adverse Event (SAE)   [ Time Frame: From Baseline (Day 1) until Follow-up (average of 3 study weeks) ]

13.  Primary:   Number of Participants Who Received the Indicated Concomitant Medications During the Study Period   [ Time Frame: From Baseline (Day 1) until Follow-up (average of 3 study weeks) ]

14.  Primary:   Change From Baseline in Mean Blood Pressure at Days 1, 4, 7, and 10   [ Time Frame: Baseline and Days 1, 4, 7, and 10 ]

15.  Primary:   Change From Baseline in Mean Heart Rate at Days 1, 4, 7, and 10   [ Time Frame: Baseline and Days 1, 4, 7, and 10 ]

16.  Primary:   Number of Participants With Abnormal Electrocardiogram (ECG) Findings   [ Time Frame: Screening; Days 1, 7, 10, 11; and Follow-up (up to Study Day 21) ]

17.  Primary:   Number of Participants With the Indicated Grade 3 and Grade 4 Laboratory Abnormalities   [ Time Frame: Screening; Days 1, 3, 7, and 10; and Follow-up (up to Study Day 21) ]

18.  Secondary:   Mean Change From Baseline in Plasma HIV-1 RNA to Nadir (Maximum Change) at Day 11   [ Time Frame: Baseline and Day 11 ]

19.  Secondary:   Median Change From Baseline in Plasma HIV-1 RNA to Nadir (Maximum Change) at Day 11   [ Time Frame: Baseline and Day 11 ]

20.  Secondary:   Plasma HIV-1 RNA Rate of Decline Over 10 Days   [ Time Frame: Day 1 to Day 11 ]

21.  Secondary:   Number of Participants With HIV-1 RNA <400 Copies/mL and <50 Copies/mL   [ Time Frame: Day 11 ]

22.  Secondary:   Median Change From Baseline in Plasma HIV-1 RNA Levels During the Follow-up Period (Days 11 to 21)   [ Time Frame: Baseline and Follow-up period (Days 11 to 21) ]

23.  Secondary:   Mean Change From Baseline in Plasma HIV-1 RNA Levels During the Follow-up Period (Days 11 to 21)   [ Time Frame: Baseline and Follow-up period (Days 11 to 21) ]

24.  Secondary:   Median Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count at Day 11   [ Time Frame: Baseline and Day 11 ]

25.  Secondary:   Number of Participants With the Emergence of Drug Resistance Mutations   [ Time Frame: Baseline and Day 11 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

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.


Limitations and Caveats
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
No text entered.  


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


No publications provided


Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00708110     History of Changes
Other Study ID Numbers: 111521
Study First Received: June 30, 2008
Results First Received: August 22, 2013
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration