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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 acronym: DISCOVER
StatusTerminated
PhasePhase 3
Started2016-09-02
View on ClinicalTrials.gov ↗
Why the trial stopped
Following review of accumulated safety data from DISCOVER and real-world use of F/TAF, the sponsor determined that the long-term safety of F/TAF had been demonstrated and no further safety monitoring within the study was required.

Amendment history

2026-08-14
Active, Not Recruiting→Terminated Study Status, IPDSharing v31
Trial terminated: Following review of accumulated safety data from DISCOVER and real-world use of F/TAF, the sponsor determined that the...
Trial statusActive, Not Recruiting→Terminated
Completion dateestimated 2026-07→confirmed 2026-07-29
2026-04-14
Study Status v30
Completion date2027-09→2026-07
2025-11-06
6 amendments v24-v29
6 re-verifications since 2022-10-31, no change to tracked fields
2022-06-28
Study Status, Arms and Interventions, References, Document Section v23
Completion date2022-09→2027-09
2021-11-22
Study Status v22
Re-verified, no change to tracked fields
Show 21 earlier versions
2021-06-07
Study Status, Arms and Interventions v21
Completion date2022-12→2022-09
Study arms3→4
2020-12-21
Study Status, Contacts/Locations, References v20
Study sites93 entries, revised
city: West Palm Beach, country: United States, geoPoint: {'lat': 26.71534, 'lon': -80.05337}, state: Florida, zip: 3340133407
Publicationsdetails revised at 1 of 7 entries
2020-05-28
Study Identification, Study Status, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events v19
Completion date2021-09→2022-12
Secondary endpointsdetails revised at 3 of 15 entries
Study title+22 characters
Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenami [...]
2020-03-03
Study Status, Study Description, Study Design, Outcome Measures, References, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v18
Results first postednot stated→2020-03-17
Enrollment target5400→5399
Secondary endpoints15 entries, revised
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 in the Blinded Phase in a Subset of Participants Percent Change From Baseline in Spine BMD at Week 48 in the Blinded Phase in a Subset of Participants Assessment of Renal Biomarkers at Week 48 in the Blinded Phase: Percent Change from Baseline in Urine Beta-2-Microglobulin to Creatinine Ratio Assessment of Renal Biomarkers at Week 48 in the Blinded phase: Percent Change from Baseline in Urine RBP to Creatinine Ratio Assessment of Renal Biomarkers [...] Percent Change From Baseline in Urine Beta-2-Microglobulin to Creatinine Ra [...] [...]
Primary endpoints1 entry, revised
Incidence of HIV-1 infectionInfection perPer 100 Person Years (PY)
Publications6 to 7 entries
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.
2019-08-15
Study Status v17
Completion date2021-07→2021-09
2019-02-08
Study Status, Contacts/Locations v16
Primary completion dateestimated 2019-02→confirmed 2019-01-31
Study sites93 entries, revised
city: New York, country: United States, geoPoint: {'lat': 40.71427, 'lon': -74.00597}, state: New York, zip: 1006510032
2018-10-15
Study Status, Study Description, Outcome Measures v15
Primary completion date2019-05→2019-02
Completion date2020-09→2021-07
Secondary endpoints14 to 15 entries
Incidence of HIV-1 Infection per 100 PY
2018-05-30
Study Status, Study Description, Arms and Interventions, Outcome Measures v14
Primary completion date2019-02→2019-05
Secondary endpoints15 to 14 entries
PercentAssessment Change From Baseline inof Renal Biomarkers of Urine Retinol-Binding Protein (RBP) to Creatinine Ratio at Week 48 in the Blinded Phase: Percent Change Fromfrom Baseline in Renal Biomarkers ofUrine Beta-2-Microglobulin to Creatinine Ratio Assessment of Renal Biomarkers at Week 48 in the Blinded phase: Percent Change from Baseline in Urine RBP to Creatinine Ratio Assessment of Renal Biomarkers at Week 48 in the Blinded Phase Percent: Change From Baseline in Renal BiomarkersDistribution of UP and Urine Protein- to- Creatinine Ratio (UPCR) at Week 48 in the Blinded PhaseCategories [...]
Primary endpoints1 entry, revised
Incidence of SeroconversionsHIV-1 infection per 100 Person Years (PY) as Defined by the HIV-1 RNA by Polymerase Chain Reaction (PCR)
2018-01-10
Study Status, Contacts/Locations v13
Study sites94→93
2017-07-11
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v12
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 5000→confirmed 5400
Study sites97→94
2017-06-28
Study Status v11
Re-verified, no change to tracked fields
2017-05-30
Study Status, Contacts/Locations v10
Study sites88→97
2017-05-02
Study Status, Contacts/Locations v9
Study sites98→88
2017-04-05
Study Status, Eligibility v8
Re-verified, no change to tracked fields
2017-03-21
Study Status, Contacts/Locations v7
Study sites98 entries, revised
city: Fort Lauderdale, contacts: [{'email': 'ann@therafirst.com', 'phone': '954-564-4222', 'role': 'CONTACT'}], country: United States, geoPoint: {'lat': 26.12231, 'lon': [...] lorida, status: RECRUITING, zip: 33308 city: Fort Lauderdale, contacts: [{'email': 'verne@grichmond.com', 'phone': '954-524-2250', 'phoneExt': '211', 'role': 'CONTACT'}], country: United States, geoPoint: {'lat': 26.12231, 'lon': [...] , state: Florida, status: RECRUITING, zip: 33316 city: Miami, contacts: [{'email': 'ttanner@med.miami.edu', 'phone': '305-243-4668', 'role': 'CONTACT'}, {'phone': '(305)-243-5621', 'role': 'CONTACT'}], [...] [...]
2017-03-06
Study Identification, Study Status, Eligibility v6
Start date2016-09→2016-09-02
Eligibility criteria-538 characters
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 a [...] story of rectal gonorrhea or chlamydia in the past 24 weeks No suspected or known active, serious infection(s) Adequate renal function: estimated glomerular filtration rat [...] /dL, or normal direct bilirubin Absolute neutrophil count ≥ 15001000/mm^3; platelets within≥ normal limits75,000/mm^3; hemoglobin ≥ 10 g/dL InKey the 30 days prior to screening have not received, or during the study will not be receiving, other approved or investigational agents for treatment o [...] [...]
2017-02-23
Study Status, Contacts/Locations v5
Study sites97→98
2017-01-26
Study Status, Oversight, Contacts/Locations v4
Study sites97 entries, revised
city: Sacramento, country: United States, geoPoint: {'lat': 38.58157, 'lon': -121.4944}, state: California, status: NOT_YET_RECRUITINGRECRUITING, zip: 95817 city: Sacramento, country: United States, geoPo [...] t': 38.58157, 'lon': -121.4944}, state: California, status: NOT_YET_RECRUITINGRECRUITING, zip: 95825 city: Torrance, country: United States, geoPoin [...] ': 33.83585, 'lon': -118.34063}, state: California, status: NOT_YET_RECRUITINGRECRUITING, zip: 90502 city: Springfield, country: United States, geoP [...] 42.10148, 'lon': -72.58981}, state: Massachusetts, status: NOT_YET_RECRUITINGRECRUITING, zip: 01105 [...] [...]
2016-12-22
Study Status, Contacts/Locations v3
Study sites97 entries, revised
city: Newport Beach, country: United States, geoPoint: {'lat': 33.61891, 'lon': -117.92895}, state: California, status: NOT_YET_RECRUITINGRECRUITING, zip: 92866 city: San Francisco, country: United States, ge [...] ': 37.77493, 'lon': -122.41942}, state: California, status: NOT_YET_RECRUITINGRECRUITING, zip: 94102 city: San Francisco, country: United States, ge [...] ': 37.77493, 'lon': -122.41942}, state: California, status: NOT_YET_RECRUITINGRECRUITING, zip: 94103 city: New Haven, country: United States, geoPoi [...] ': 41.30815, 'lon': -72.92816}, state: Connecticut, status: NOT_YET_RECRUITINGRECRUITING, zip: 6 [...] [...]
2016-11-16
Study Status, Contacts/Locations v2
Study sites92→97
2016-09-16
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Completion date2020-05→2020-09
Start date2016-08→2016-09
Study sites59→92
Eligibility criteria+109 characters
[...] tional agents for treatment or prevention of HIV-1 infection (post-exposure prophylaxis (PEP), in accordance with local medical practice, is acceptable during the study) No evidence of acute viral hepatitis, and no evidence of ch [...]
2016-07-20
Original filing
Gilead Sciences
107 trials monitored
See 8 trials at risk
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.
Trial Details
NCT Number NCT02842086
Lead Sponsor Gilead Sciences
Conditions Pre-Exposure Prophylaxis of HIV-1 Infection
Enrollment 5,399 participants
Start Date 2016-09-02
Primary Completion 2019-01-31 (estimated)
Study Completion 2026-07-29 (estimated)
Updated on ClinicalTrials.gov 2026-09-08