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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02881320




Registration number
NCT02881320
Ethics application status
Date submitted
23/08/2016
Date registered
26/08/2016

Titles & IDs
Public title
Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1
Scientific title
A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Adolescents and Children
Secondary ID [1] 0 0
2016-002345-39
Secondary ID [2] 0 0
GS-US-380-1474
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV-1 Infection 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - B/F/TAF (Adult Strength)
Treatment: Drugs - B/F/TAF (Low Dose)
Treatment: Drugs - B/F/TAF (TOS)
Treatment: Drugs - B/F/TAF (TOS)
Treatment: Drugs - B/F/TAF (TOS)
Treatment: Drugs - B/F/TAF (TOS)

Experimental: Cohort 1 (12 to < 18 years of age and weight = 35 kg) - * Part A: Participants will participate in an Intensive PK evaluation at Week 2 or Week 4 and continue to receive the adult strength B/F/TAF FDC through Week 48.
* Part B: Following confirmation of BIC PK data from Cohort 1 Part A, participants will receive the adult strength B/F/TAF through Week 48.

Experimental: Cohort 2 (6 to < 12 years of age and weight = 25 kg) - * Part A: Participants will participate in an Intensive PK evaluation at Week 2 or Week 4 and continue to receive the adult strength B/F/TAF FDC through Week 48.
* Part B: Following confirmation of BIC PK data from Cohort 2 Part A, participants will receive the adult strength B/F/TAF FDC through Week 48.

Experimental: Cohort 3 (= 2 years of age and weight = 14 to < 25 kg) - * Part A: Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive the low dose B/F/TAF FDC tablet through Week 48.
* Part B: Following confirmation of BIC PK data from Cohort 3 Part A, participants will receive the low dose B/F/TAF FDC tablet through Week 48.

Experimental: Cohort 4 Group 1 (= 2 years of age and weight = 14 to < 25 kg) - Due to Cohort 3 Part A Intensive PK evaluation at Week 2 with the low dose B/F/TAF FDC tablet, participants will not participate in an Intensive PK evaluation at Week 2.

Participants will receive B/F/TAF FDC tablets for oral suspension (TOS) once daily through Week 48.

Experimental: Cohort 4 Group 2 (= 1 month of age and weight = 10 to < 14 kg) - Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive B/F/TAF FDC TOS twice daily through Week 48.

Experimental: Cohort 4 Group 3 (= 1 month of age and weight = 6 to < 10 kg) - Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive B/F/TAF FDC TOS twice daily through Week 48.

Experimental: Cohort 4 Group 4 (= 1 month of age and weight = 3 to < 6 kg) - Participants will participate in an Intensive PK evaluation at Week 2 after which they will continue to receive B/F/TAF FDC TOS twice daily through Week 48.

Experimental: Open-Label Extension - Following Week 48, participants in countries where B/F/TAF is not available may have the option to receive adult strength B/F/TAF FDC, low dose B/F/TAF FDC, or B/F/TAF FDC TOS (based on age and weight) until it becomes available for use according to the participant's age and weight or the product becomes accessible to participants through an access program.


Treatment: Drugs: B/F/TAF (Adult Strength)
50/200/25 mg FDC tablets administered orally once daily without regard to food.

Treatment: Drugs: B/F/TAF (Low Dose)
30/120/15 mg FDC tablets administered orally once daily without regard to food.

Treatment: Drugs: B/F/TAF (TOS)
2 x B/F/TAF 15/60/7.5 mg (total daily dose 30/120/15 mg) FDC tablets administered orally as TOS, once daily.

Treatment: Drugs: B/F/TAF (TOS)
2 x B/F/TAF 3.75/15/1.88 mg (total daily dose 15/60/7.52 mg) FDC tablets administered orally as TOS, twice daily.

Treatment: Drugs: B/F/TAF (TOS)
1 x B/F/TAF 3.75/15/1.88 mg (total daily dose 7.5/30/3.76 mg) FDC tablets administered orally as TOS, twice daily.

Treatment: Drugs: B/F/TAF (TOS)
1 x B/F/TAF 1.88/7.5/0.94 mg (total daily dose 3.76/15/1.88 mg) FDC tablets administered orally as TOS, twice daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
PK Parameter: AUCtau of Bictegravir
Timepoint [1] 0 0
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Primary outcome [2] 0 0
PK Parameter: Ctau of Bictegravir
Timepoint [2] 0 0
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Primary outcome [3] 0 0
PK Parameter: AUClast of TAF (Cohort 4)
Timepoint [3] 0 0
Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Primary outcome [4] 0 0
PK Parameter: Cmax of TAF (Cohort 4)
Timepoint [4] 0 0
Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Primary outcome [5] 0 0
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 24
Timepoint [5] 0 0
Up to 24 weeks
Primary outcome [6] 0 0
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 24
Timepoint [6] 0 0
Up to 24 weeks
Secondary outcome [1] 0 0
Proportion of Participants with Plasma HIV-1 RNA < 50 copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Proportion of Participants with Plasma HIV-1 RNA < 50 copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
Timepoint [2] 0 0
Week 48
Secondary outcome [3] 0 0
Change from Baseline in CD4+ Cell Counts at Week 24
Timepoint [3] 0 0
Baseline, Week 24
Secondary outcome [4] 0 0
Change from Baseline in CD4+ Cell Counts at Week 48
Timepoint [4] 0 0
Baseline, Week 48
Secondary outcome [5] 0 0
Change from Baseline in CD4+ Cell Count Percentages at Week 24
Timepoint [5] 0 0
Baseline, Week 24
Secondary outcome [6] 0 0
Change from Baseline in CD4+ Cell Count Percentages at Week 48
Timepoint [6] 0 0
Baseline, Week 48
Secondary outcome [7] 0 0
PK Parameter: Tmax of Bictegravir
Timepoint [7] 0 0
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Secondary outcome [8] 0 0
PK Parameter: Cmax of Bictegravir
Timepoint [8] 0 0
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Secondary outcome [9] 0 0
PK Parameter: AUClast of Bictegravir
Timepoint [9] 0 0
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Secondary outcome [10] 0 0
PK Parameter: T1/2 of Bictegravir
Timepoint [10] 0 0
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Secondary outcome [11] 0 0
PK Parameter: Apparent Clearance (CL) of Bictegravir
Timepoint [11] 0 0
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Secondary outcome [12] 0 0
PK Parameter: Apparent Vz of Bictegravir
Timepoint [12] 0 0
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Secondary outcome [13] 0 0
PK Parameter: AUCtau of TAF and FTC
Timepoint [13] 0 0
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Secondary outcome [14] 0 0
PK Parameter: AUClast of TAF and FTC (Cohorts 1, 2, and 3)
Timepoint [14] 0 0
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose
Secondary outcome [15] 0 0
PK Parameter: AUClast of FTC (Cohorts 4)
Timepoint [15] 0 0
Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Secondary outcome [16] 0 0
PK Parameter: Cmax of TAF and FTC (Cohorts 1, 2, and 3)
Timepoint [16] 0 0
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose
Secondary outcome [17] 0 0
PK Parameter: Cmax of FTC (Cohorts 4)
Timepoint [17] 0 0
Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Secondary outcome [18] 0 0
PK Parameter: Ctau of TAF and FTC
Timepoint [18] 0 0
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Secondary outcome [19] 0 0
PK Parameter: Tmax of TAF and FTC
Timepoint [19] 0 0
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Secondary outcome [20] 0 0
PK Parameter: T1/2 of TAF and FTC
Timepoint [20] 0 0
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Secondary outcome [21] 0 0
PK Parameter: Apparent CL of TAF and FTC
Timepoint [21] 0 0
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Secondary outcome [22] 0 0
PK Parameter: Apparent Vz of TAF and FTC
Timepoint [22] 0 0
Week 2 or Week 4 for Cohorts 1 & 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, & 24 hours postdose; Week 2 for Cohort 3: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, & 24 hours post-dose; Week 2 for Cohort 4: 0 (predose) 0.5, 1, 2, 4, & 8 hours postdose
Secondary outcome [23] 0 0
Percentage of Participants Experiencing Treatment-Emergent Adverse Events Through Week 48
Timepoint [23] 0 0
Up to 48 weeks
Secondary outcome [24] 0 0
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 48
Timepoint [24] 0 0
Up to 48 weeks
Secondary outcome [25] 0 0
Acceptability of B/F/TAF Formulation at Day 1 (All Cohorts)
Timepoint [25] 0 0
Day 1
Secondary outcome [26] 0 0
Palatability of B/F/TAF Formulation at Day 1 (All Cohorts)
Timepoint [26] 0 0
Day 1
Secondary outcome [27] 0 0
Acceptability of B/F/TAF Formulation at Week 4 (All Cohorts)
Timepoint [27] 0 0
Week 4
Secondary outcome [28] 0 0
Palatability of B/F/TAF Formulation at Week 4 (All Cohorts)
Timepoint [28] 0 0
Week 4
Secondary outcome [29] 0 0
Acceptability of B/F/TAF Formulation at Week 24 (Cohort 3 and Cohort 4)
Timepoint [29] 0 0
Week 24
Secondary outcome [30] 0 0
Palatability of B/F/TAF Formulation at Week 24 (Cohort 3 and Cohort 4)
Timepoint [30] 0 0
Week 24
Secondary outcome [31] 0 0
Acceptability of B/F/TAF Formulation at Week 48 (Cohort 3 and Cohort 4)
Timepoint [31] 0 0
Week 48
Secondary outcome [32] 0 0
Palatability of B/F/TAF Formulation at Week 48 (Cohort 3 and Cohort 4)
Timepoint [32] 0 0
Week 48
Secondary outcome [33] 0 0
Acceptability of B/F/TAF Formulation at Week 1 (Cohort 4)
Timepoint [33] 0 0
Week 1
Secondary outcome [34] 0 0
Palatability of B/F/TAF Formulation at Week 1 (Cohort 4)
Timepoint [34] 0 0
Week 1
Secondary outcome [35] 0 0
Acceptability of B/F/TAF Formulation at Week 2 (Cohort 4)
Timepoint [35] 0 0
Week 2
Secondary outcome [36] 0 0
Palatability of B/F/TAF Formulation at Week 2 (Cohort 4)
Timepoint [36] 0 0
Week 2

Eligibility
Key inclusion criteria
Key

Cohort 1: HIV-1 infected adolescents (12 to < 18 years of age and screening weight = 35 kg) who are virologically suppressed for = 6 months prior to screening. Cohort 2: HIV-1 infected children (6 to < 12 years of age and screening weight = 25 kg) who are virologically suppressed for = 6 months prior to screening.

Cohort 3: HIV-1 infected children (= 2 years of age and screening weight of = 14 to < 25 kg) who are virologically suppressed for = 6 months prior to screening.

Cohort 4 Group 1: HIV-1 infected children (= 2 years of age and screening weight of = 14 to < 25 kg) who are virologically suppressed for = 6 months prior to screening and unable to swallow tablets.

* Documented plasma HIV-1 ribonucleic acid (RNA) < 50 copies/mL on a stable regimen (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is = 50 copies/mL) for = 6 months preceding the Screening visit. Unconfirmed virologic elevations of = 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable. If the lower limit of detection of the local HIV-1 RNA assay is < 50 copies/mL (eg, < 20 copies/mL), the plasma HIV-1 RNA level cannot exceed 50 copies/mL on two consecutive HIV-1 RNA tests.
* Stable antiretroviral regimen of 2 nucleoside reverse transcriptase inhibitors (NRTIs) in combination with a third agent for a minimum of 6 months prior to the screening visit. Individuals undergoing dose modifications to their antiretroviral regimen for growth or who are switching medication formulation(s) are considered to be on a stable antiretroviral regimen.
* Estimated glomerular filtration rate (eGFR) = 90 mL/min/1.73 m^2 according to the Schwartz Formula.
* No documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV), or integrase strand transfer inhibitors (INSTIs) including, but not limited to, the reverse transcriptase resistance mutations K65R and M184V/I.

Cohort 4 Group 2-4: HIV-1 infected children (= 1 month of age and screening weight of = 3 to < 14 kg) who are treatment naive or on antiretroviral (ARV) treatment for = 1 month prior to screening.

* Positive confirmatory HIV test (confirmatory nucleic acid-based testing if < 18 months of age).
* On a stable ARV regimen for = 1 month or treatment naive (Individual is considered treatment naive if ARVs were given for prevention of mother-to-child transmission but not for HIV treatment).
* For < 1 year of age, eGFR = the minimum normal values for age according to the information below using the Schwartz Formula,

* 30 mL/min/1.73 m^2 for age > 4 weeks to = 95 days.
* 39 mL/min/1.73 m^2 for age = 96 days to = 6 months.
* 49 mL/min/1.73 m^2 for age > 6 months to < 12 months.
* For = 1 year of age, eGFR = 90 mL/min/1.73 m^2 using the Schwartz Formula.
* No documented or suspected resistance to FTC, TFV, or INSTIs including, but not limited to, the reverse transcriptase resistance mutation K65R.
* For individuals < 14 kg, M184V/I AND HIV-1 RNA < 50 copies/mL will be allowed. Individuals with HIV-1 RNA > 50 copies/mL should not have FTC, TFV, or INSTI resistance mutations.
* Last dose of nevirapine (NVP) or efavirenz (EFV), if applicable, = 14 days prior to enrollment.

Note: Other protocol defined Inclusion/
Minimum age
1 Month
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/09/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
Accrual to date
Final
177
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
District of Columbia
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
South Africa
State/province [9] 0 0
Bloemfontein
Country [10] 0 0
South Africa
State/province [10] 0 0
Cape Town
Country [11] 0 0
South Africa
State/province [11] 0 0
CapeTown
Country [12] 0 0
South Africa
State/province [12] 0 0
Dundee
Country [13] 0 0
South Africa
State/province [13] 0 0
Durban
Country [14] 0 0
South Africa
State/province [14] 0 0
Johannesburg
Country [15] 0 0
South Africa
State/province [15] 0 0
Pretoria
Country [16] 0 0
South Africa
State/province [16] 0 0
Soweto
Country [17] 0 0
Thailand
State/province [17] 0 0
Bangkok
Country [18] 0 0
Thailand
State/province [18] 0 0
Khon Kaen
Country [19] 0 0
Uganda
State/province [19] 0 0
Kampala

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02881320