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Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Adolescents

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: NCT02276612
Recruitment Status : Completed
First Posted : October 28, 2014
Results First Posted : February 22, 2018
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV
Intervention Drug: E/C/F/TAF
Enrollment 60
Recruitment Details Participants were enrolled at study sites in South Africa and the United States. The first participant was screened on 03 December 2014. The last study visit occurred on 23 October 2017.
Pre-assignment Details 68 participants were screened.
Arm/Group Title E/C/F/TAF (12 - 17 Years of Age) E/C/F/TAF (≥ 18 Years of Age)
Hide Arm/Group Description

Participants 12 - 17 years of age received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 48 weeks.

Following completion of 48 weeks of treatment, eligible participants 12 - 17 years of age received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food during the open-label extension phase.

Participants 18 years of age or older received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.

Following completion of 48 weeks of treatment, eligible participants ≥ 18 years of age received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food during the open-label extension phase.

Note: Participants from Gilead Study GS-US-162-0112 were allowed to roll over into this Study GS-US-292-1515 even if they were 18 years or older at the time of screening.

Period Title: Overall Study
Started 50 10
Completed 46 10
Not Completed 4 0
Reason Not Completed
Death             1             0
Pregnancy             1             0
Withdrew Consent             1             0
Lost to Follow-up             1             0
Arm/Group Title E/C/F/TAF (12 - 17 Years of Age) E/C/F/TAF (≥ 18 Years of Age) Total
Hide Arm/Group Description E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older Total of all reporting groups
Overall Number of Baseline Participants 50 10 60
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 10 participants 60 participants
15  (1.6) 19  (1.2) 16  (2.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 10 participants 60 participants
Female
32
  64.0%
3
  30.0%
35
  58.3%
Male
18
  36.0%
7
  70.0%
25
  41.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 10 participants 60 participants
Hispanic or Latino
1
   2.0%
0
   0.0%
1
   1.7%
Not Hispanic or Latino
49
  98.0%
10
 100.0%
59
  98.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 10 participants 60 participants
Black
49
  98.0%
9
  90.0%
58
  96.7%
White
1
   2.0%
0
   0.0%
1
   1.7%
Other
0
   0.0%
1
  10.0%
1
   1.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 10 participants 60 participants
United States
8
  16.0%
0
   0.0%
8
  13.3%
South Africa
42
  84.0%
10
 100.0%
52
  86.7%
HIV-1 RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 10 participants 60 participants
< 50 copies/mL
49
  98.0%
9
  90.0%
58
  96.7%
≥ 50 copies/mL
1
   2.0%
1
  10.0%
2
   3.3%
CD4 Cell Count  
Mean (Standard Deviation)
Unit of measure:  cells/µL
Number Analyzed 50 participants 10 participants 60 participants
753  (222.5) 776  (179.9) 757  (214.8)
CD4 Percentage  
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 50 participants 10 participants 60 participants
34.3  (6.72) 35.9  (6.53) 34.6  (6.66)
1.Primary Outcome
Title Incidence of Treatment-Emergent Serious Adverse Events
Hide Description The percentage of participants experiencing any treatment-emergent serious adverse event was summarized.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Arm/Group Title E/C/F/TAF (12 - 17 Years of Age) E/C/F/TAF (≥ 18 Years of Age)
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age
E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older
Overall Number of Participants Analyzed 50 10
Measure Type: Number
Unit of Measure: percentage of participants
4.0 0
2.Primary Outcome
Title Incidence of Treatment-Emergent Adverse Events
Hide Description The percentage of participants experiencing any treatment-emergent adverse event was summarized.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Arm/Group Title E/C/F/TAF (12 - 17 Years of Age) E/C/F/TAF (≥ 18 Years of Age)
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age
E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older
Overall Number of Participants Analyzed 50 10
Measure Type: Number
Unit of Measure: percentage of participants
92.0 100.0
3.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 24 (FDA-defined Snapshot Analysis)
Hide Description The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Arm/Group Title E/C/F/TAF (12 - 17 Years of Age) E/C/F/TAF (≥ 18 Years of Age)
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age
E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older
Overall Number of Participants Analyzed 50 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
96.0
(86.3 to 99.5)
100.0
(69.2 to 100.0)
4.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 48 (FDA-defined Snapshot Analysis)
Hide Description The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
Arm/Group Title E/C/F/TAF (12 - 17 Years of Age) E/C/F/TAF (≥ 18 Years of Age)
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age
E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older
Overall Number of Participants Analyzed 50 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
90.0
(78.2 to 96.7)
100.0
(69.2 to 100.0)
5.Secondary Outcome
Title Change From Baseline in CD4 Cell Count at Week 24
Hide Description [Not Specified]
Time Frame Baseline; Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with on-treatment data were analyzed.
Arm/Group Title E/C/F/TAF (12 - 17 Years of Age) E/C/F/TAF (≥ 18 Years of Age)
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age
E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older
Overall Number of Participants Analyzed 50 10
Mean (Standard Deviation)
Unit of Measure: cells/µL
-72  (189.8) -85  (245.9)
6.Secondary Outcome
Title Change From Baseline in CD4 Cell Count at Week 48
Hide Description [Not Specified]
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with on-treatment data were analyzed.
Arm/Group Title E/C/F/TAF (12 - 17 Years of Age) E/C/F/TAF (≥ 18 Years of Age)
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age
E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older
Overall Number of Participants Analyzed 48 10
Mean (Standard Deviation)
Unit of Measure: cells/µL
-43  (201.1) -41  (143.0)
7.Secondary Outcome
Title Change From Baseline in CD4 Percentage at Week 24
Hide Description [Not Specified]
Time Frame Baseline; Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with on-treatment data were analyzed.
Arm/Group Title E/C/F/TAF (12 - 17 Years of Age) E/C/F/TAF (≥ 18 Years of Age)
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age
E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older
Overall Number of Participants Analyzed 50 10
Mean (Standard Deviation)
Unit of Measure: percentage
-0.6  (5.46) -0.6  (5.46)
8.Secondary Outcome
Title Change From Baseline in CD4 Percentage at Week 48
Hide Description [Not Specified]
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with on-treatment data were analyzed.
Arm/Group Title E/C/F/TAF (12 - 17 Years of Age) E/C/F/TAF (≥ 18 Years of Age)
Hide Arm/Group Description:
E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age
E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older
Overall Number of Participants Analyzed 48 10
Mean (Standard Deviation)
Unit of Measure: percentage
-0.1  (3.95) -1.1  (7.29)
Time Frame Up to 128 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
 
Arm/Group Title E/C/F/TAF (12 - 17 Years of Age) E/C/F/TAF (≥ 18 Years of Age)
Hide Arm/Group Description

E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 12 - 17 years of age.

Following completion of 48 weeks of treatment, eligible participants 12 - 17 years of age received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food during the open-label extension phase.

E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks in participants 18 years of age or older.

Following completion of 48 weeks of treatment, eligible participants ≥ 18 years of age received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food during the open-label extension phase.

All-Cause Mortality
E/C/F/TAF (12 - 17 Years of Age) E/C/F/TAF (≥ 18 Years of Age)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/50 (2.00%)   0/10 (0.00%) 
Hide Serious Adverse Events
E/C/F/TAF (12 - 17 Years of Age) E/C/F/TAF (≥ 18 Years of Age)
Affected / at Risk (%) Affected / at Risk (%)
Total   3/50 (6.00%)   0/10 (0.00%) 
Gastrointestinal disorders     
Vomiting  1  1/50 (2.00%)  0/10 (0.00%) 
General disorders     
Electrocution  1  1/50 (2.00%)  0/10 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  1/50 (2.00%)  0/10 (0.00%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
E/C/F/TAF (12 - 17 Years of Age) E/C/F/TAF (≥ 18 Years of Age)
Affected / at Risk (%) Affected / at Risk (%)
Total   42/50 (84.00%)   10/10 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  3/50 (6.00%)  0/10 (0.00%) 
Lymphadenopathy  1  1/50 (2.00%)  1/10 (10.00%) 
Neutropenia  1  3/50 (6.00%)  0/10 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  2/50 (4.00%)  1/10 (10.00%) 
Abdominal pain upper  1  3/50 (6.00%)  1/10 (10.00%) 
Anal fissure  1  0/50 (0.00%)  1/10 (10.00%) 
Constipation  1  2/50 (4.00%)  1/10 (10.00%) 
Diarrhoea  1  7/50 (14.00%)  2/10 (20.00%) 
Vomiting  1  8/50 (16.00%)  1/10 (10.00%) 
General disorders     
Axillary pain  1  0/50 (0.00%)  1/10 (10.00%) 
Chest pain  1  0/50 (0.00%)  1/10 (10.00%) 
Malaise  1  2/50 (4.00%)  1/10 (10.00%) 
Pain  1  0/50 (0.00%)  1/10 (10.00%) 
Infections and infestations     
Acarodermatitis  1  3/50 (6.00%)  0/10 (0.00%) 
Bronchitis  1  3/50 (6.00%)  0/10 (0.00%) 
Gastroenteritis  1  2/50 (4.00%)  1/10 (10.00%) 
Herpes simplex  1  0/50 (0.00%)  1/10 (10.00%) 
Lower respiratory tract infection  1  3/50 (6.00%)  0/10 (0.00%) 
Oral herpes  1  1/50 (2.00%)  2/10 (20.00%) 
Otitis media  1  2/50 (4.00%)  1/10 (10.00%) 
Pharyngitis  1  3/50 (6.00%)  0/10 (0.00%) 
Sinusitis  1  3/50 (6.00%)  1/10 (10.00%) 
Sinusitis bacterial  1  0/50 (0.00%)  1/10 (10.00%) 
Tonsillitis  1  0/50 (0.00%)  1/10 (10.00%) 
Upper respiratory tract infection  1  11/50 (22.00%)  6/10 (60.00%) 
Urinary tract infection  1  4/50 (8.00%)  0/10 (0.00%) 
Viral upper respiratory tract infection  1  7/50 (14.00%)  0/10 (0.00%) 
Injury, poisoning and procedural complications     
Thermal burn  1  3/50 (6.00%)  0/10 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  0/50 (0.00%)  1/10 (10.00%) 
Aspartate aminotransferase increased  1  0/50 (0.00%)  1/10 (10.00%) 
Blood creatine phosphokinase increased  1  0/50 (0.00%)  1/10 (10.00%) 
Bone density decreased  1  2/50 (4.00%)  1/10 (10.00%) 
Vitamin D decreased  1  7/50 (14.00%)  0/10 (0.00%) 
Weight decreased  1  1/50 (2.00%)  1/10 (10.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  4/50 (8.00%)  1/10 (10.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/50 (2.00%)  1/10 (10.00%) 
Muscle spasms  1  3/50 (6.00%)  0/10 (0.00%) 
Pain in extremity  1  1/50 (2.00%)  1/10 (10.00%) 
Nervous system disorders     
Dizziness  1  3/50 (6.00%)  0/10 (0.00%) 
Headache  1  6/50 (12.00%)  2/10 (20.00%) 
Reproductive system and breast disorders     
Dysmenorrhoea  1  3/50 (6.00%)  0/10 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/50 (0.00%)  1/10 (10.00%) 
Cough  1  12/50 (24.00%)  5/10 (50.00%) 
Nasal obstruction  1  3/50 (6.00%)  3/10 (30.00%) 
Oropharyngeal pain  1  0/50 (0.00%)  1/10 (10.00%) 
Skin and subcutaneous tissue disorders     
Acne  1  6/50 (12.00%)  0/10 (0.00%) 
Pruritus  1  1/50 (2.00%)  1/10 (10.00%) 
Rash  1  5/50 (10.00%)  0/10 (0.00%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
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.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Disclosures & Data Transparency
Organization: Gilead Sciences
Phone: 1-833-445-3230
EMail: GileadClinicalTrials@gilead.com
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02276612    
Other Study ID Numbers: GS-US-292-1515
2014-002673-11 ( EudraCT Number )
First Submitted: October 24, 2014
First Posted: October 28, 2014
Results First Submitted: January 25, 2018
Results First Posted: February 22, 2018
Last Update Posted: November 19, 2018