Trial Outcomes & Findings for Pharmacokinetics, Safety, and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR) in Adolescents (NCT NCT01721109)
NCT ID: NCT01721109
Last Updated: 2018-08-17
Results Overview
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
50 participants
Primary outcome timeframe
Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10
Results posted on
2018-08-17
Participant Flow
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 study visit occurred on 29 January 2018.
56 participants were screened.
Participant milestones
| Measure |
EVG/COBI/FTC/TDF
Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) (150/150/200/300 mg) single-tablet regimen (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.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
EVG/COBI/FTC/TDF
Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) (150/150/200/300 mg) single-tablet regimen (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.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Non- Compliance with Study Drug
|
3
|
|
Overall Study
Withdrew Consent
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Pharmacokinetics, Safety, and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR) in Adolescents
Baseline characteristics by cohort
| Measure |
EVG/COBI/FTC/TDF
n=50 Participants
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
|
|---|---|
|
Age, Continuous
|
15 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
34 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Permitted
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
14 Participants
n=5 Participants
|
|
HIV-1 RNA
|
4.60 log10 copies/mL
STANDARD_DEVIATION 0.551 • n=5 Participants
|
|
HIV-1 RNA Category
≤ 100,000 copies/mL
|
40 Participants
n=5 Participants
|
|
HIV-1 RNA Category
> 100,000 copies/mL
|
10 Participants
n=5 Participants
|
|
CD4 Cell Count
|
399 cells/µL
STANDARD_DEVIATION 127.6 • n=5 Participants
|
|
CD4 Cell Count Category
≤ 199 cells/µL
|
2 Participants
n=5 Participants
|
|
CD4 Cell Count Category
200 ≥ and ≤ 349 cells/µL
|
16 Participants
n=5 Participants
|
|
CD4 Cell Count Category
350 ≥ and ≤ 499 cells/µL
|
22 Participants
n=5 Participants
|
|
CD4 Cell Count Category
≥ 500 cells/µL
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10Population: PK Substudy Analysis Set: all enrolled and treated participants from Part A who had evaluable steady-state pharmacokinetic profiles of the respective analyte of interest at the Day 10 intensive PK visit.
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Outcome measures
| Measure |
EVG/COBI/FTC/TDF
n=14 Participants
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
|
|---|---|
|
For Part A, Pharmacokinetic (PK) Parameter: AUCtau of EVG
|
31620.9 ng•h/mL
Standard Deviation 13978.07
|
PRIMARY outcome
Timeframe: Up to Week 48 plus 30 daysPopulation: Safety Analysis Set: all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
EVG/COBI/FTC/TDF
n=50 Participants
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
|
|---|---|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs) and All Treatment-Emergent Adverse Events (AEs)
SAEs
|
4 Participants
|
|
Incidence of Treatment-Emergent Serious Adverse Events (SAEs) and All Treatment-Emergent Adverse Events (AEs)
AEs
|
45 Participants
|
SECONDARY outcome
Timeframe: Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10Population: PK Substudy Analysis Set: all enrolled and treated participants from Part A who had evaluable steady-state pharmacokinetic profiles of the respective analyte of interest at the Day 10 intensive PK visit.
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Outcome measures
| Measure |
EVG/COBI/FTC/TDF
n=14 Participants
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
|
|---|---|
|
For Part A, PK Parameter: Ctau of EVG, FTC, Tenofovir (TFV), and COBI
EVG
|
579.3 ng/mL
Standard Deviation 455.20
|
|
For Part A, PK Parameter: Ctau of EVG, FTC, Tenofovir (TFV), and COBI
FTC
|
102.6 ng/mL
Standard Deviation 30.85
|
|
For Part A, PK Parameter: Ctau of EVG, FTC, Tenofovir (TFV), and COBI
TFV
|
86.6 ng/mL
Standard Deviation 23.58
|
|
For Part A, PK Parameter: Ctau of EVG, FTC, Tenofovir (TFV), and COBI
COBI
|
39.7 ng/mL
Standard Deviation 68.52
|
SECONDARY outcome
Timeframe: Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10Population: PK Substudy Analysis Set: all enrolled and treated participants from Part A who had evaluable steady-state pharmacokinetic profiles of the respective analyte of interest at the Day 10 intensive PK visit.
Cmax is defined as the maximum concentration of drug.
Outcome measures
| Measure |
EVG/COBI/FTC/TDF
n=14 Participants
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
|
|---|---|
|
For Part A, PK Parameter: Cmax of EVG, FTC, TFV, and COBI
EVG
|
2624.3 ng/mL
Standard Deviation 1239.64
|
|
For Part A, PK Parameter: Cmax of EVG, FTC, TFV, and COBI
FTC
|
2217.4 ng/mL
Standard Deviation 664.64
|
|
For Part A, PK Parameter: Cmax of EVG, FTC, TFV, and COBI
TFV
|
438.5 ng/mL
Standard Deviation 170.69
|
|
For Part A, PK Parameter: Cmax of EVG, FTC, TFV, and COBI
COBI
|
1500.4 ng/mL
Standard Deviation 975.29
|
SECONDARY outcome
Timeframe: Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10Population: PK Substudy Analysis Set: all enrolled and treated participants from Part A who had evaluable steady-state pharmacokinetic profiles of the respective analyte of interest at the Day 10 intensive PK visit.
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Outcome measures
| Measure |
EVG/COBI/FTC/TDF
n=14 Participants
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
|
|---|---|
|
For Part A, PK Parameter: AUCtau of FTC, TFV, and COBI
COBI
|
11884.8 ng•h/mL
Standard Deviation 11220.94
|
|
For Part A, PK Parameter: AUCtau of FTC, TFV, and COBI
FTC
|
15136.5 ng•h/mL
Standard Deviation 4702.06
|
|
For Part A, PK Parameter: AUCtau of FTC, TFV, and COBI
TFV
|
4450.7 ng•h/mL
Standard Deviation 1312.27
|
SECONDARY outcome
Timeframe: Weeks 24 and 48Population: Full Analysis Set: all participants who were enrolled in the study and received at least 1 dose of study drug.
Outcome measures
| Measure |
EVG/COBI/FTC/TDF
n=50 Participants
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
|
|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24 and 48 as Defined by the FDA Snapshot Analysis
Week 24
|
88.0 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24 and 48 as Defined by the FDA Snapshot Analysis
Week 48
|
88.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 24 and 48Population: Full Analysis Set: all participants who were enrolled in the study and received at least 1 dose of study drug.
Outcome measures
| Measure |
EVG/COBI/FTC/TDF
n=50 Participants
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
|
|---|---|
|
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Weeks 24 and 48 as Defined by the FDA Snapshot Analysis
Week 24
|
94.0 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Weeks 24 and 48 as Defined by the FDA Snapshot Analysis
Week 48
|
92.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 24 and 48Population: Full Analysis Set: all participants who were enrolled in the study and received at least 1 dose of study drug.
Outcome measures
| Measure |
EVG/COBI/FTC/TDF
n=50 Participants
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
|
|---|---|
|
Change From Baseline in Plasma log10 HIV-1 RNA at Weeks 24 and 48
Change at Week 24
|
-3.08 log10 copies/mL
Standard Deviation 0.922
|
|
Change From Baseline in Plasma log10 HIV-1 RNA at Weeks 24 and 48
Change at Week 48
|
-3.16 log10 copies/mL
Standard Deviation 0.705
|
SECONDARY outcome
Timeframe: Baseline; Weeks 24 and 48Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
EVG/COBI/FTC/TDF
n=49 Participants
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
|
|---|---|
|
Change From Baseline in CD4+ Cell Count at Weeks 24 and 48
Change at Week 24
|
178 cells/µL
Standard Deviation 165.4
|
|
Change From Baseline in CD4+ Cell Count at Weeks 24 and 48
Change at Week 48
|
229 cells/µL
Standard Deviation 245.3
|
SECONDARY outcome
Timeframe: Baseline; Weeks 24 and 48Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
EVG/COBI/FTC/TDF
n=49 Participants
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
|
|---|---|
|
Change From Baseline in CD4 Percentage at Weeks 24 and 48
Change at Week 24
|
7.4 percentage
Standard Deviation 4.70
|
|
Change From Baseline in CD4 Percentage at Weeks 24 and 48
Change at Week 48
|
8.1 percentage
Standard Deviation 5.34
|
Adverse Events
EVG/COBI/FTC/TDF
Serious events: 5 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EVG/COBI/FTC/TDF
n=50 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
1/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Food poisoning
|
2.0%
1/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.0%
1/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Immune reconstitution inflammatory syndrome
|
2.0%
1/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Disseminated tuberculosis
|
2.0%
1/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis shigella
|
2.0%
1/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
2.0%
1/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
2.0%
1/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Suicidal behaviour
|
2.0%
1/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.0%
1/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.0%
1/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
EVG/COBI/FTC/TDF
n=50 participants at risk
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
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
16.0%
8/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
8.0%
4/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
16.0%
8/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
6.0%
3/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
10/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
6.0%
3/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
8.0%
4/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
6.0%
3/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
8.0%
4/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oral herpes
|
6.0%
3/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oropharyngeal gonococcal infection
|
6.0%
3/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
12.0%
6/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Proctitis gonococcal
|
6.0%
3/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory tract infection viral
|
6.0%
3/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Secondary syphilis
|
6.0%
3/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Tonsillitis
|
6.0%
3/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
36.0%
18/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
6.0%
3/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
6.0%
3/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
8.0%
4/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.0%
3/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
18.0%
9/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.0%
3/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
8.0%
4/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
24.0%
12/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Acne
|
16.0%
8/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
6.0%
3/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
6.0%
3/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.0%
4/50 • Baseline up to the last dose date plus 30 days (maximum exposure: 250.7 weeks)
Safety Analysis Set: all participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER