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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002673-11 | EudraCT Number |
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The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) in HIV-infected virologically suppressed adolescents 12 to < 18 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E/C/F/TAF | Experimental | Treatment-experienced participants will receive open-label E/C/F/TAF for up to 48 weeks. After completion of 48 weeks of treatment, all eligible participants will be given the option to participate in an open-label extension phase to receive E/C/F/TAF until a) the participant turns 18 years old and E/C/F/TAF is commercially available for use in adults in the country the participant is enrolled, or b) E/C/F/TAF becomes commercially available for use in the participant's current age group in the country the participant is enrolled, or c) E/C/F/TAF becomes accessible to participants through an access program, or d) Gilead Sciences elects to terminate development of E/C/F/TAF in the applicable country. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E/C/F/TAF | Drug | 150/150/200/10 mg fixed-dose combination (FDC) tablet administered orally once daily with food |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Serious Adverse Events | The percentage of participants experiencing any treatment-emergent serious adverse event was summarized. | Up to Week 48 |
| Incidence of Treatment-Emergent Adverse Events | The percentage of participants experiencing any treatment-emergent adverse event was summarized. | Up to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 24 (FDA-defined Snapshot Analysis) | 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. |
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Key Inclusion Criteria:
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.
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampa | Florida | United States | ||||
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
18 months after study completion
A secured external environment with username, password, and RSA code.
68 participants were screened.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | E/C/F/TAF (12 - 17 Years of Age) | 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. |
| FG001 | E/C/F/TAF (≥ 18 Years of Age) | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | E/C/F/TAF (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 12 - 17 years of age |
| BG001 | E/C/F/TAF (≥ 18 Years of Age) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Treatment-Emergent Serious Adverse Events | The percentage of participants experiencing any treatment-emergent serious adverse event was summarized. | Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Up to Week 48 |
|
Up to 128 weeks plus 30 days
Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | E/C/F/TAF (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 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosures & Data Transparency | Gilead Sciences | 1-833-445-3230 | GileadClinicalTrials@gilead.com |
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| ID | Term |
|---|---|
| D000069545 | Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D000069547 | Cobicistat |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Week 24 |
| Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 48 (FDA-defined Snapshot Analysis) | 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. | Week 48 |
| Change From Baseline in CD4 Cell Count at Week 24 | Baseline; Week 24 |
| Change From Baseline in CD4 Cell Count at Week 48 | Baseline; Week 48 |
| Change From Baseline in CD4 Percentage at Week 24 | Baseline; Week 24 |
| Change From Baseline in CD4 Percentage at Week 48 | Baseline; Week 48 |
| Detroit |
| Michigan |
| United States |
| New York | New York | United States |
| Memphis | Tennessee | United States |
| Cape Town | South Africa |
| Johannesburg | South Africa |
| Soweto | South Africa |
| Withdrew Consent |
|
| Lost to Follow-up |
|
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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| HIV-1 RNA Category | Count of Participants | Participants |
|
| CD4 Cell Count | Mean | Standard Deviation | cells/µL |
|
| CD4 Percentage | Mean | Standard Deviation | percentage |
|
|
|
| Primary | Incidence of Treatment-Emergent Adverse Events | The percentage of participants experiencing any treatment-emergent adverse event was summarized. | Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Up to Week 48 |
|
|
|
| Secondary | Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 24 (FDA-defined Snapshot Analysis) | 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. | Full Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 24 |
|
|
|
| Secondary | Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 48 (FDA-defined Snapshot Analysis) | 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. | Full Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 48 |
|
|
|
| Secondary | Change From Baseline in CD4 Cell Count at Week 24 | Participants in the Full Analysis Set with on-treatment data were analyzed. | Posted | Mean | Standard Deviation | cells/µL | Baseline; Week 24 |
|
|
|
| Secondary | Change From Baseline in CD4 Cell Count at Week 48 | Participants in the Full Analysis Set with on-treatment data were analyzed. | Posted | Mean | Standard Deviation | cells/µL | Baseline; Week 48 |
|
|
|
| Secondary | Change From Baseline in CD4 Percentage at Week 24 | Participants in the Full Analysis Set with on-treatment data were analyzed. | Posted | Mean | Standard Deviation | percentage | Baseline; Week 24 |
|
|
|
| Secondary | Change From Baseline in CD4 Percentage at Week 48 | Participants in the Full Analysis Set with on-treatment data were analyzed. | Posted | Mean | Standard Deviation | percentage | Baseline; Week 48 |
|
|
|
| 1 |
| 50 |
| 3 |
| 50 |
| 42 |
| 50 |
| EG001 | E/C/F/TAF (≥ 18 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. 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. | 0 | 10 | 0 | 10 | 10 | 10 |
| Electrocution | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 20.0 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Axillary pain | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Acarodermatitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Sinusitis bacterial | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Bone density decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Vitamin D decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
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:
| D009930 |
| Organic Chemicals |
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |