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Pharmacokinetics, Safety, and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR) in Adolescents

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01721109
First received: November 1, 2012
Last updated: February 24, 2017
Last verified: February 2017
Results First Received: February 24, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Acquired Immunodeficiency Syndrome
HIV Infections
Intervention: Drug: EVG/COBI/FTC/TDF

  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
Participants were enrolled at study sites in the United States, South Africa, and Thailand. The first participant was screened on 06 December 2012. The last Week 48 study visit occurred on 22 October 2015.

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

Reporting Groups
  Description
EVG/COBI/FTC/TDF Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; EVG/COBI/FTC/TDF) (150/150/200/300 mg) single-tablet regiment (STR) administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase.

Participant Flow for 2 periods

Period 1:   Main Phase
    EVG/COBI/FTC/TDF
STARTED   50 
COMPLETED   49 
NOT COMPLETED   1 
Non-Compliance with Study Drug                1 

Period 2:   Extension Phase
    EVG/COBI/FTC/TDF
STARTED   40 [1] 
COMPLETED   3 [2] 
NOT COMPLETED   37 
Non-Compliance with Study Drug                2 
Still on Study                35 
[1] Only 40 participants entered the optional extension phase.
[2] Participants turned 18 years old or the study drug became commercially available in their country.



  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.
Safety Analysis Set: all participants who received at least 1 dose of study drug.

Reporting Groups
  Description
EVG/COBI/FTC/TDF EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase

Baseline Measures
   EVG/COBI/FTC/TDF 
Overall Participants Analyzed 
[Units: Participants]
 50 
Age 
[Units: Years]
Mean (Standard Deviation)
 15  (1.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      15  30.0% 
Male      35  70.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
Asian   14 
Black   34 
White   1 
Other   1 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
Hispanic or Latino   2 
Not Hispanic or Latino   47 
Not Permitted   1 
Region of Enrollment 
[Units: Participants]
 
United States   14 
South Africa   22 
Thailand   14 
HIV-1 RNA 
[Units: Log10 copies/mL]
Mean (Standard Deviation)
 4.60  (0.551) 
HIV-1 RNA Category 
[Units: Participants]
Count of Participants
 
≤ 100,000 copies/mL   40 
> 100,000 copies/mL   10 
CD4 Cell Count 
[Units: cells/µL]
Mean (Standard Deviation)
 399  (127.6) 
CD4 Cell Count Category 
[Units: Participants]
Count of Participants
 
≤ 199 cells/µL   2 
200 ≥ and ≤ 349 cells/µL   16 
350 ≥ and ≤ 499 cells/µL   22 
≥ 500 cells/µL   10 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   For Part A, Pharmacokinetic (PK) Parameter: AUCtau of EVG   [ Time Frame: Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10 ]

2.  Primary:   For Part B, Incidence of Treatment-Emergent Serious Adverse Events (SAEs) and All Treatment-Emergent Adverse Events (AEs)   [ Time Frame: Up to Week 48 plus 30 days ]

3.  Secondary:   For Part A, PK Parameter: Ctau of EVG, FTC, Tenofovir (TFV), and COBI   [ Time Frame: Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10 ]

4.  Secondary:   For Part A, PK Parameter: Cmax of EVG, FTC, TFV, and COBI   [ Time Frame: Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10 ]

5.  Secondary:   For Part A, PK Parameter: AUCtau of FTC, TFV, and COBI   [ Time Frame: Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10 ]

6.  Secondary:   For Part B, Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24 and 48 as Defined by the FDA Snapshot Analysis   [ Time Frame: Weeks 24 and 48 ]

7.  Secondary:   For Part B, Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Weeks 24 and 48 as Defined by the FDA Snapshot Analysis   [ Time Frame: Weeks 24 and 48 ]

8.  Secondary:   Change From Baseline in Plasma log10 HIV-1 RNA at Weeks 24 and 48   [ Time Frame: Baseline; Weeks 24 and 48 ]

9.  Secondary:   Change From Baseline in CD4+ Cell Count at Weeks 24 and 48   [ Time Frame: Baseline; Weeks 24 and 48 ]

10.  Secondary:   Change From Baseline in CD4 Percentage at Weeks 24 and 48   [ Time Frame: Baseline; Weeks 24 and 48 ]


  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
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  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: Clinical Trial Disclosures
Organization: Gilead Sciences
e-mail: ClinicalTrialDisclosures@gilead.com


Publications of Results:
Gaur A, Fourie J, Chokephaibulkit K, Bekker L-G, Yin X, Custodio J, Bennett S, Cheng A, Quirk E. Pharmacokinetics, Efficacy and Safety of an Integrase Inhibitor-Based Single-Tablet Regimen in HIV-Infected Treatment-Naïve Adolescents. 21st Conference on Retroviruses and Opportunistic Infections (CROI). March 2014. Boston, MA, USA
Chokephaibulkit K, Gaur A, Fourie J, Bekker L-G, Shao Y, Custodio J, Bennett S, Cheng A, Quirk E. Safety and Efficacy of the Integrase Inhibitor-Based Stribild Single-Tablet Regimen in HIV-Infected Adolescents Through 24 Weeks of Treatment. 20th International AIDS Conference. July 2014. Melbourne, Australia
Porter DP, Bennett S, Quirk E, Miller MD, White KL. Lack of Emergent Resistance in HIV-1-Infected Adolescents on Elvitegravir-Based STRs. 22nd Conference on Retroviruses and Opportunistic Infections (CROI). February 2015. Seattle, WA, USA
Kizito H, Gaur A, Prasitsuebsai W, Rakhmanina N, Chokephaibulkit K, Fourie J, Bekker LG, Shao Y, Bennett S, Quirk E. Changes in renal laboratory markers and bone mineral density in treatment-naïve HIV-1-infected adolescents initiating INSTI-based single-tablet regimens containing tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF). 8th IAS Conference on HIV Pathogenesis, Treatment & Prevention. July 2015. Vancouver, Canada


Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01721109     History of Changes
Other Study ID Numbers: GS-US-236-0112
2015-000313-40 ( EudraCT Number )
Study First Received: November 1, 2012
Results First Received: February 24, 2017
Last Updated: February 24, 2017