Back to resultsStudy to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection (DISCOVER)
Primary Purpose
Pre-Exposure Prophylaxis of HIV-1 Infection
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
F/TAF
F/TDF
F/TAF Placebo
F/TDF Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pre-Exposure Prophylaxis of HIV-1 Infection
Eligibility Criteria
Key Inclusion Criteria:
- Must be at high risk of sexual acquisition of HIV
- HIV-1 negative status
MSM and TGW (male at birth) who have at least one of the following:
- condomless anal intercourse with at least two unique male partners in the past 12 weeks (partners must be either HIV-infected or of unknown HIV status)
- documented history of syphilis in the past 24 weeks
- documented history of rectal gonorrhea or chlamydia in the past 24 weeks
- Adequate renal function: estimated glomerular filtration rate ≥ 60 mL/min according to the Cockcroft-Gault formula
Adequate liver and hematologic function:
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN) and total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
- Absolute neutrophil count ≥ 1000/mm^3; platelets ≥ 75,000/mm^3; hemoglobin ≥ 10 g/dL
Key Exclusion Criteria
- Grade 3 or Grade 4 proteinuria or glycosuria that is unexplained or not clinically manageable.
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
F/TAF
F/TDF
Open-label
Open-Label Extension
Arm Description
F/TAF+ F/TDF placebo for at least 96 weeks
F/TDF+ F/TAF placebo for at least 96 weeks
Once all participants have been on blinded treatment for at least 96 weeks, the study will be unblinded and participants will be offered the option to continue on open-label F/TAF treatment for 96 weeks.
Participants who remain on study at Open-label Week 96 will have the option to continue on open-label F/TAF treatment in the Open-label extension phase for 408 weeks.
Outcomes
Primary Outcome Measures
Incidence of HIV-1 Infection Per 100 Person Years (PY)
The incidence of HIV-1 infection rate per 100 PY was calculated as the number of participants who became HIV infected during the study after the first dose of study drug divided by the sum of all participants' years (where a year is 365.25 days) of follow-up while at risk of HIV infection during the study.
HIV-1 infection is defined by one or more of the following criteria of contributing HIV tests performed via central lab or local lab:
Serologic evidence of seroconversion (reactive screening HIV Antigen/Antibody or Antibody test, confirmed by reactive HIV-1/HIV-2 differentiation assay), excluding HIV vaccinated participants, or
Virologic evidence of HIV-1 infection (positive qualitative HIV-1 RNA test or any detectable quantitative HIV-1 RNA test), or
Evidence of acute HIV-1 infection (reactive p24 Antigen or positive qualitative or quantitative RNA, in the absence of reactive HIV-1 Antibody results)
Secondary Outcome Measures
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 in the Blinded Phase
Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%.
Percent Change From Baseline in Spine BMD at Week 48 in the Blinded Phase
Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%.
Percent Change From Baseline in Urine Beta-2-Microglobulin to Creatinine Ratio at Week 48 in the Blinded Phase
Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%.
For urine creatinine, value of < 1 was handled as a missing value in its summary and the calculation of related ratios.
Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48 in the Blinded Phase
Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%.
For urine creatinine, value of < 1 was handled as a missing value in its summary and the calculation of related ratios.
Number of Participants by Urine Protein (UP) and Urine Protein to Creatinine Ratio (UPCR) Categories at Week 48 in the Blinded Phase
The UPCR was only calculated when corresponding UP ≥ 4.0 mg/dL. The UPCR "≤ 200 mg/g" category includes both participants with UP < 4.0 mg/dL and participants with UPCR ≤ 200 mg/g.
Change From Baseline in Serum Creatinine at Week 48 in the Blinded Phase
Incidence of HIV-1 Infection Per 100 PY
The incidence of HIV-1 infection rate per 100 PY was calculated as the number of participants who became HIV infected during the study after the first dose of study drug divided by the sum of all participants' years (where a year is 365.25 days) of follow-up while at risk of HIV infection during the study.
HIV-1 infection is defined by one or more of the following criteria of contributing HIV tests performed via central lab or local lab:
Serologic evidence of seroconversion (reactive screening HIV Antigen/Antibody or Antibody test, confirmed by reactive HIV-1/HIV-2 differentiation assay), excluding HIV vaccinated participants, or
Virologic evidence of HIV-1 infection (positive qualitative HIV-1 RNA test or any detectable quantitative HIV-1 RNA test), or
Evidence of acute HIV-1 infection (reactive p24 Antigen or positive qualitative or quantitative RNA, in the absence of reactive HIV-1 Antibody results)
Percent Change From Baseline in Hip BMD at Week 96 in the Blinded Phase
Percent Change = Change from baseline at Week 96 visit/value at baseline * 100%.
Percent Change From Baseline in Spine BMD at Week 96 in the Blinded Phase
Percent Change = Change from baseline at Week 96 visit/value at baseline * 100%.
Percent Change From Baseline in Urine Beta-2-Microglobulin to Creatinine Ratio at Week 96 in the Blinded Phase
Percent Change = Change from baseline at Week 96 visit/value at baseline * 100%.
For urine creatinine, value of < 1 was handled as a missing value in its summary and the calculation of related ratios.
Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96 in the Blinded Phase
Percent Change = Change from baseline at Week 96 visit/value at baseline * 100%.
For urine creatinine, value of < 1 was handled as a missing value in its summary and the calculation of related ratios.
Number of Participants by UP and UPCR Categories at Week 96 in the Blinded Phase
The UPCR was only calculated when corresponding UP ≥ 4.0 mg/dL. The UPCR "≤ 200 mg/g" category includes both participants with UP < 4.0 mg/dL and participants with UPCR ≤ 200 mg/g.
Change From Baseline in Serum Creatinine at Week 96 in the Blinded Phase
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02842086
Brief Title
Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection
Acronym
DISCOVER
Official Title
A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2, 2016 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
September 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of this study is to assess the rates of HIV-1 infection in Men (MSM) and transgender women (TGW) who have sex with men and who are administered daily emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir disoproxil fumarate (F/TDF) with a minimum follow-up of 48 weeks and at least 50% of participants have 96 weeks of follow-up after randomization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Exposure Prophylaxis of HIV-1 Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
5399 (Actual)
8. Arms, Groups, and Interventions
Arm Title
F/TAF
Arm Type
Experimental
Arm Description
F/TAF+ F/TDF placebo for at least 96 weeks
Arm Title
F/TDF
Arm Type
Experimental
Arm Description
F/TDF+ F/TAF placebo for at least 96 weeks
Arm Title
Open-label
Arm Type
Experimental
Arm Description
Once all participants have been on blinded treatment for at least 96 weeks, the study will be unblinded and participants will be offered the option to continue on open-label F/TAF treatment for 96 weeks.
Arm Title
Open-Label Extension
Arm Type
Experimental
Arm Description
Participants who remain on study at Open-label Week 96 will have the option to continue on open-label F/TAF treatment in the Open-label extension phase for 408 weeks.
Intervention Type
Drug
Intervention Name(s)
F/TAF
Other Intervention Name(s)
Descovy®
Intervention Description
200/25 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
F/TDF
Other Intervention Name(s)
Truvada®
Intervention Description
200/300 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
F/TAF Placebo
Intervention Description
Tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
F/TDF Placebo
Intervention Description
Tablet administered orally once daily
Primary Outcome Measure Information:
Title
Incidence of HIV-1 Infection Per 100 Person Years (PY)
Description
The incidence of HIV-1 infection rate per 100 PY was calculated as the number of participants who became HIV infected during the study after the first dose of study drug divided by the sum of all participants' years (where a year is 365.25 days) of follow-up while at risk of HIV infection during the study.
HIV-1 infection is defined by one or more of the following criteria of contributing HIV tests performed via central lab or local lab:
Serologic evidence of seroconversion (reactive screening HIV Antigen/Antibody or Antibody test, confirmed by reactive HIV-1/HIV-2 differentiation assay), excluding HIV vaccinated participants, or
Virologic evidence of HIV-1 infection (positive qualitative HIV-1 RNA test or any detectable quantitative HIV-1 RNA test), or
Evidence of acute HIV-1 infection (reactive p24 Antigen or positive qualitative or quantitative RNA, in the absence of reactive HIV-1 Antibody results)
Time Frame
When all participants completed minimum follow-up of 48 weeks and at least 50% of the participants completed 96 weeks of follow-up after randomization or permanently discontinued from the study (maximum 125 weeks)
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 in the Blinded Phase
Description
Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%.
Time Frame
Baseline, Week 48
Title
Percent Change From Baseline in Spine BMD at Week 48 in the Blinded Phase
Description
Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%.
Time Frame
Baseline, Week 48
Title
Percent Change From Baseline in Urine Beta-2-Microglobulin to Creatinine Ratio at Week 48 in the Blinded Phase
Description
Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%.
For urine creatinine, value of < 1 was handled as a missing value in its summary and the calculation of related ratios.
Time Frame
Baseline, Week 48
Title
Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48 in the Blinded Phase
Description
Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%.
For urine creatinine, value of < 1 was handled as a missing value in its summary and the calculation of related ratios.
Time Frame
Baseline, Week 48
Title
Number of Participants by Urine Protein (UP) and Urine Protein to Creatinine Ratio (UPCR) Categories at Week 48 in the Blinded Phase
Description
The UPCR was only calculated when corresponding UP ≥ 4.0 mg/dL. The UPCR "≤ 200 mg/g" category includes both participants with UP < 4.0 mg/dL and participants with UPCR ≤ 200 mg/g.
Time Frame
Baseline, Week 48
Title
Change From Baseline in Serum Creatinine at Week 48 in the Blinded Phase
Time Frame
Baseline, Week 48
Title
Incidence of HIV-1 Infection Per 100 PY
Description
The incidence of HIV-1 infection rate per 100 PY was calculated as the number of participants who became HIV infected during the study after the first dose of study drug divided by the sum of all participants' years (where a year is 365.25 days) of follow-up while at risk of HIV infection during the study.
HIV-1 infection is defined by one or more of the following criteria of contributing HIV tests performed via central lab or local lab:
Serologic evidence of seroconversion (reactive screening HIV Antigen/Antibody or Antibody test, confirmed by reactive HIV-1/HIV-2 differentiation assay), excluding HIV vaccinated participants, or
Virologic evidence of HIV-1 infection (positive qualitative HIV-1 RNA test or any detectable quantitative HIV-1 RNA test), or
Evidence of acute HIV-1 infection (reactive p24 Antigen or positive qualitative or quantitative RNA, in the absence of reactive HIV-1 Antibody results)
Time Frame
When all participants have 96 weeks of follow-up after randomization or permanently discontinued from the study (maximum 157 weeks)
Title
Percent Change From Baseline in Hip BMD at Week 96 in the Blinded Phase
Description
Percent Change = Change from baseline at Week 96 visit/value at baseline * 100%.
Time Frame
Baseline, Week 96
Title
Percent Change From Baseline in Spine BMD at Week 96 in the Blinded Phase
Description
Percent Change = Change from baseline at Week 96 visit/value at baseline * 100%.
Time Frame
Baseline, Week 96
Title
Percent Change From Baseline in Urine Beta-2-Microglobulin to Creatinine Ratio at Week 96 in the Blinded Phase
Description
Percent Change = Change from baseline at Week 96 visit/value at baseline * 100%.
For urine creatinine, value of < 1 was handled as a missing value in its summary and the calculation of related ratios.
Time Frame
Baseline, Week 96
Title
Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96 in the Blinded Phase
Description
Percent Change = Change from baseline at Week 96 visit/value at baseline * 100%.
For urine creatinine, value of < 1 was handled as a missing value in its summary and the calculation of related ratios.
Time Frame
Baseline, Week 96
Title
Number of Participants by UP and UPCR Categories at Week 96 in the Blinded Phase
Description
The UPCR was only calculated when corresponding UP ≥ 4.0 mg/dL. The UPCR "≤ 200 mg/g" category includes both participants with UP < 4.0 mg/dL and participants with UPCR ≤ 200 mg/g.
Time Frame
Baseline, Week 96
Title
Change From Baseline in Serum Creatinine at Week 96 in the Blinded Phase
Time Frame
Baseline, Week 96
Title
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Time Frame
First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks)
Title
Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality
Time Frame
First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks)
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Men and Transgender Women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria:
Must be at high risk of sexual acquisition of HIV
HIV-1 negative status
MSM and TGW (male at birth) who have at least one of the following:
condomless anal intercourse with at least two unique male partners in the past 12 weeks (partners must be either HIV-infected or of unknown HIV status)
documented history of syphilis in the past 24 weeks
documented history of rectal gonorrhea or chlamydia in the past 24 weeks
Adequate renal function: estimated glomerular filtration rate ≥ 60 mL/min according to the Cockcroft-Gault formula
Adequate liver and hematologic function:
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN) and total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
Absolute neutrophil count ≥ 1000/mm^3; platelets ≥ 75,000/mm^3; hemoglobin ≥ 10 g/dL
Key Exclusion Criteria
Grade 3 or Grade 4 proteinuria or glycosuria that is unexplained or not clinically manageable.
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90069
Country
United States
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94103
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34982
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30312
Country
United States
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60613
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01105
Country
United States
City
Berkley
State/Province
Michigan
ZIP/Postal Code
48072
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7215
Country
United States
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
City
Graz
ZIP/Postal Code
8051
Country
Austria
City
Vienna
ZIP/Postal Code
1090
Country
Austria
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2T1
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1K2
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2l 4P9
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L5B1
Country
Canada
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
City
Hvidovre
State/Province
Region Hovedstaden
ZIP/Postal Code
2650
Country
Denmark
City
Aarhus N
State/Province
Region Midtjylland
ZIP/Postal Code
8200
Country
Denmark
City
Copenhagen
State/Province
RegionH
ZIP/Postal Code
2100
Country
Denmark
City
Odense
ZIP/Postal Code
5000
Country
Denmark
City
Nice
State/Province
Alpe Maritimes
ZIP/Postal Code
6202
Country
France
City
Marseille
State/Province
Provence
ZIP/Postal Code
13006
Country
France
City
Paris
State/Province
Provence
ZIP/Postal Code
75020
Country
France
City
Paris cedex 10
ZIP/Postal Code
75475
Country
France
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany
City
Berlin
ZIP/Postal Code
10439
Country
Germany
City
Berlin
ZIP/Postal Code
10777
Country
Germany
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
City
Dublin 7
State/Province
Dublin
ZIP/Postal Code
D07 A8NN
Country
Ireland
City
Dublin
ZIP/Postal Code
8
Country
Ireland
City
Milan
ZIP/Postal Code
20127
Country
Italy
City
Roma
ZIP/Postal Code
00149
Country
Italy
City
Amsterdam
Country
Netherlands
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
City
Barcelona
ZIP/Postal Code
08015
Country
Spain
City
Madrid
ZIP/Postal Code
28010
Country
Spain
City
Vigo
ZIP/Postal Code
36312
Country
Spain
City
Soho
State/Province
London
ZIP/Postal Code
W1D 6AQ
Country
United Kingdom
City
Whitechapel
State/Province
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH3 9HA
Country
United Kingdom
City
Brighton
State/Province
Sussex
ZIP/Postal Code
BN2 1ES
Country
United Kingdom
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
City
London
ZIP/Postal Code
E9 6SR
Country
United Kingdom
City
London
ZIP/Postal Code
SE18 4QH
Country
United Kingdom
City
London
ZIP/Postal Code
SE5 9RJ
Country
United Kingdom
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
City
London
ZIP/Postal Code
WC1E 6JB
Country
United Kingdom
City
Manchester
ZIP/Postal Code
M13 0FH
Country
United Kingdom
12. IPD Sharing Statement
Citations:
Citation
Hare B. The Phase 3 DISCOVER Study: Daily F/TAF or F/TDF for HIV Preexposure Prophylaxis [Presentation]. Conference on Retroviruses and Opportunistic Infections (CROI); 2019 04-07 March; Seattle, WA.
Results Reference
result
PubMed Identifier
32711800
Citation
Mayer KH, Molina JM, Thompson MA, Anderson PL, Mounzer KC, De Wet JJ, DeJesus E, Jessen H, Grant RM, Ruane PJ, Wong P, Ebrahimi R, Zhong L, Mathias A, Callebaut C, Collins SE, Das M, McCallister S, Brainard DM, Brinson C, Clarke A, Coll P, Post FA, Hare CB. Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. Lancet. 2020 Jul 25;396(10246):239-254. doi: 10.1016/S0140-6736(20)31065-5.
Results Reference
result
PubMed Identifier
34197772
Citation
Ogbuagu O, Ruane PJ, Podzamczer D, Salazar LC, Henry K, Asmuth DM, Wohl D, Gilson R, Shao Y, Ebrahimi R, Cox S, Kintu A, Carter C, Das M, Baeten JM, Brainard DM, Whitlock G, Brunetta JM, Kronborg G, Spinner CD; DISCOVER study team. Long-term safety and efficacy of emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV-1 pre-exposure prophylaxis: week 96 results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet HIV. 2021 Jul;8(7):e397-e407. doi: 10.1016/S2352-3018(21)00071-0. Erratum In: Lancet HIV. 2021 Dec;8(12):e734.
Results Reference
derived
PubMed Identifier
34021709
Citation
Glidden DV, Das M, Dunn DT, Ebrahimi R, Zhao Y, Stirrup OT, Baeten JM, Anderson PL. Using the adherence-efficacy relationship of emtricitabine and tenofovir disoproxil fumarate to calculate background hiv incidence: a secondary analysis of a randomized, controlled trial. J Int AIDS Soc. 2021 May;24(5):e25744. doi: 10.1002/jia2.25744.
Results Reference
derived
Links:
URL
https://www.gileadclinicaltrials.com/study/?id=GS-US-412-2055
Description
Gilead Clinical Trials Website
Learn more about this trial
Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection
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