ClinicalTrials.gov
ClinicalTrials.gov Menu

Two Part Study to Evaluate Pharmacokinetics, Safety, and Antiviral Activity of Elvitegravir Administered With a PI/r Background Regimen for ARV Treatment-Experienced Pediatric Participants

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: NCT01923311
Recruitment Status : Terminated
First Posted : August 15, 2013
Results First Posted : July 11, 2018
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Acquired Immune Deficiency Syndrome (AIDS)
HIV Infections
Interventions: Drug: EVG
Drug: Background regimen

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled at study sites in North America, Europe, Asia, and Africa. The first participant was screened on 26 August 2013. The last study visit occurred on 03 November 2017.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

48 participants were screened.

The study was discontinued after enrollment of only Cohort 1, Part B and Cohort 2, Part A. The study close-out was triggered by the voluntary withdrawal of single-agent Vitekta® sale based solely on low utilization of the product, and was not a result of any ongoing or new safety issue.


Reporting Groups
  Description
Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL Elvitegravir (EVG) 50 mg, or 85 mg, or 150 mg tablet administered once daily (QD) for at least 48 weeks, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following ritonavir (RTV) boosted-protease inhibitors (PI/r): lopinavir/r (Kaletra; LPV/r), atazanavir/r (ATV/r), darunavir/r (DRV/r), tipranavir/r (TPV/r), or fosamprenavir/r (FPV/r). Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG.
Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.).

Participant Flow:   Overall Study
    Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL   Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL
STARTED   17   14 
COMPLETED   0   13 
NOT COMPLETED   17   1 
Pregnancy                1                0 
Investigator's Discretion                1                0 
Non-Compliance with Study Drug                2                1 
Withdrew Consent                1                0 
Study Terminated by Sponsor                12                0 



  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.
Safety Analysis Set: all participants who were enrolled into the study and received at least 1 dose of study drug.

Reporting Groups
  Description
Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL EVG 50 mg, or 85 mg, or 150 mg tablet administered QD for at least 48 weeks with the option to continue receiving EVG after Week 48 in the extension phase, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.). After Week 48, participants were given the opportunity to continue receiving EVG in an extension phase, during which they attended study visits every 12 weeks, until they reached 18 years of age and EVG was commercially available for use in adults in the country in which they were enrolled; the age-appropriate EVG formulation became commercially available in the country in which they were enrolled; or Gilead elected to terminate the development of EVG.
Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL EVG 50 mg, or 85 mg tablet administered QD for 10 days, based on body weight and dependent on the coadministered background regimen. (Background regimen may consist of the following PI/r: LPV/r, ATV/r, DRV/r, TPV/r, or FPV/r. Use of additional antiretrovirals in background therapy was allowed.)
Total Total of all reporting groups

Baseline Measures
   Age 6 to < 18 Years With Screening HIV-1 RNA > 1000 Copies/mL   Age 6 to < 12 Years With Screening HIV-1 RNA < 50 Copies/mL   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   14   31 
Age 
[Units: Years]
Mean (Standard Deviation)
 14  (2.9)   9  (2.2)   12  (3.8) 
Age, Customized 
[Units: Participants]
Count of Participants
     
Age 6 to < 12 Years   2   14   16 
Age 12 to < 18 Years   15   0   15 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      11  64.7%      6  42.9%      17  54.8% 
Male      6  35.3%      8  57.1%      14  45.2% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Asian      5  29.4%      2  14.3%      7  22.6% 
Black      11  64.7%      10  71.4%      21  67.7% 
White      0   0.0%      2  14.3%      2   6.5% 
Other      1   5.9%      0   0.0%      1   3.2% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      1   7.1%      1   3.2% 
Not Hispanic or Latino      17 100.0%      13  92.9%      30  96.8% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   1   7   8 
Italy   1   0   1 
South Africa   7   0   7 
Uganda   3   3   6 
Thailand   5   2   7 
Spain   0   2   2 
HIV-1 RNA 
[Units: Log10 copies/mL]
Mean (Standard Deviation)
 4.21  (0.802)   1.33  (0.204)   2.91  (1.576) 
HIV-1 RNA Category 
[Units: Participants]
Count of Participants
     
< 50 copies/mL      0   0.0%      13  92.9%      13  41.9% 
≥ 50 to ≤ 1000 copies/mL      3  17.6%      1   7.1%      4  12.9% 
> 1000 to ≤ 100000 copies/mL      13  76.5%      0   0.0%      13  41.9% 
> 100000 copies/mL      1   5.9%      0   0.0%      1   3.2% 
Cluster of differentiation (CD4) Cell Count 
[Units: cells/uL]
Mean (Standard Deviation)
 356.6  (249.45)   810.8  (303.29)   561.7  (354.74) 
Cluster of differentiation (CD4) Cell Count Category 
[Units: Participants]
Count of Participants
     
< 50 cells/uL      0   0.0%      0   0.0%      0   0.0% 
≥ 50 to < 200 cells/uL      6  35.3%      1   7.1%      7  22.6% 
≥ 200 to < 350 cells/uL      3  17.6%      0   0.0%      3   9.7% 
≥ 350 to < 500 cells/uL      4  23.5%      0   0.0%      4  12.9% 
≥ 500 cells/uL      4  23.5%      13  92.9%      17  54.8% 
Cluster of differentiation (CD4) Percentage 
[Units: Percentage (%)]
Mean (Standard Deviation)
 17.8  (9.60)   35.5  (9.11)   25.8  (12.85) 
Type of PI in Background Regimen (Excluding Ritonavir) 
[Units: Participants]
Count of Participants
     
atazanavir      8  47.1%      1   7.1%      9  29.0% 
darunavir      3  17.6%      0   0.0%      3   9.7% 
lopinavir      6  35.3%      13  92.9%      19  61.3% 


  Outcome Measures

1.  Primary:   Pharmacokinetic (PK) Parameter: AUCtau of EVG   [ Time Frame: Predose and up to 12 hours postdose on Day 10 ]

2.  Primary:   Pharmacokinetic (PK) Parameter: Cmax of EVG at Day 10   [ Time Frame: Predose and up to 12 hours postdose on Day 10 ]

3.  Primary:   Percentage of Participants Experiencing Treatment-emergent Adverse Events   [ Time Frame: Baseline up to the last dose date plus 30 days (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years Screening HIV-1 RNA < 50 copies/mL) ]

4.  Primary:   Percentage of Participants Experiencing Laboratory Abnormalities   [ Time Frame: Baseline up to the last dose date plus 30 days (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years Screening HIV-1 RNA < 50 copies/mL) ]

5.  Secondary:   Pharmacokinetic (PK) Parameter: Ctau of EVG   [ Time Frame: Predose and up to 12 hours postdose on Day 10 ]

6.  Secondary:   Pharmacokinetic (PK) Parameter: CL/F of EVG   [ Time Frame: Predose and up to 12 hours postdose on Day 10 ]

7.  Secondary:   Pharmacokinetic (PK) Parameter: Vz/F of EVG   [ Time Frame: Predose and up to 12 hours postdose on Day 10 ]

8.  Secondary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the FDA Snapshot Algorithm   [ Time Frame: Week 24 ]

9.  Secondary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA Snapshot Algorithm   [ Time Frame: Week 48 ]

10.  Secondary:   Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24 as Defined by the FDA Snapshot Algorithm   [ Time Frame: Week 24 ]

11.  Secondary:   Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48 as Defined by the FDA Snapshot Algorithm   [ Time Frame: Week 48 ]

12.  Secondary:   Change From Baseline in Plasma Log₁₀ HIV-1 RNA at Week 24   [ Time Frame: Baseline to Week 24 ]

13.  Secondary:   Change From Baseline in Plasma Log₁₀ HIV-1 RNA at Week 48   [ Time Frame: Baseline to Week 48 ]

14.  Secondary:   Change From Baseline in CD4 Cell Count at Week 24   [ Time Frame: Baseline to Week 24 ]

15.  Secondary:   Change From Baseline in CD4 Cell Count at Week 48   [ Time Frame: Baseline to Week 48 ]

16.  Secondary:   Change From Baseline in CD4 Percentage at Week 24   [ Time Frame: Baseline to Week 24 ]

17.  Secondary:   Change From Baseline in CD4 Percentage at Week 48   [ Time Frame: Baseline to Week 48 ]

18.  Secondary:   Tanner Stage Evaluation by Sex at Week 24   [ Time Frame: Week 24 ]

19.  Secondary:   Tanner Stage Evaluation by Sex at Week 48   [ Time Frame: Week 48 ]

20.  Secondary:   Age of First Menses   [ Time Frame: Baseline through end of study (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years with Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years with Screening HIV-1 RNA < 50 copies/mL) ]

21.  Secondary:   Palatability of Oral Suspension Formulation of EVG in Appropriate Age Group   [ Time Frame: Up to Week 48 ]

22.  Secondary:   Adherence to EVG   [ Time Frame: Baseline up to the last dose date (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years Screening HIV-1 RNA < 50 copies/mL) ]


  Serious Adverse Events


  Other Adverse Events


  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.


  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.


Results Point of Contact:  
Name/Title: Gilead Clinical Study Information Center
Organization: Gilead Sciences
phone: 1-833-445-3230 (GILEAD-0)
e-mail: GileadClinicalTrials@gilead.com



Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01923311     History of Changes
Other Study ID Numbers: GS-US-183-0160
2013-001969-16 ( EudraCT Number )
First Submitted: August 9, 2013
First Posted: August 15, 2013
Results First Submitted: April 24, 2018
Results First Posted: July 11, 2018
Last Update Posted: July 11, 2018