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Trial record 1 of 79 for:    emtricitabine and tenofovir alafenamide
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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)

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ClinicalTrials.gov Identifier: NCT02842086
Recruitment Status : Active, not recruiting
First Posted : July 22, 2016
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

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 DF (F/TDF) with a minimum follow-up of 48 weeks and at least 50% of participants have 96 weeks of follow-up after randomization.

Condition or disease Intervention/treatment Phase
Pre-Exposure Prophylaxis of HIV-1 Infection Drug: F/TAF Drug: F/TDF Drug: F/TAF Placebo Drug: F/TDF Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : September 2, 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: F/TAF
F/TAF+ F/TDF placebo for at least 96 weeks
Drug: F/TAF
200/25 mg tablet administered orally once daily
Other Name: Descovy®

Drug: F/TDF Placebo
Tablet administered orally once daily

Experimental: F/TDF
F/TDF+ F/TAF placebo for at least 96 weeks
Drug: F/TDF
200/300 mg tablet administered orally once daily
Other Name: Truvada®

Drug: F/TAF Placebo
Tablet administered orally once daily

Experimental: Open-label Extension
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 in the open-label extension for 48 weeks.
Drug: F/TAF
200/25 mg tablet administered orally once daily
Other Name: Descovy®




Primary Outcome Measures :
  1. Incidence of HIV-1 infection per 100 Person Years (PY) [ Time Frame: When all participants have a minimum follow-up of 48 weeks and at least 50% of the participants have 96 weeks of follow-up after randomization ]

    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 :
  1. Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 in the Blinded Phase in a Subset of Participants [ Time Frame: Baseline; Week 48 ]
  2. Percent Change From Baseline in Spine BMD at Week 48 in the Blinded Phase in a Subset of Participants [ Time Frame: Baseline; Week 48 ]
  3. Assessment of Renal Biomarkers at Week 48 in the Blinded Phase: Percent Change from Baseline in Urine Beta-2-Microglobulin to Creatinine Ratio [ Time Frame: Baseline; Week 48 ]
  4. Assessment of Renal Biomarkers at Week 48 in the Blinded phase: Percent Change from Baseline in Urine RBP to Creatinine Ratio [ Time Frame: Baseline; Week 48 ]
  5. Assessment of Renal Biomarkers at Week 48 in the Blinded Phase: Distribution of UP and Urine Protein to Creatinine Ratio (UPCR) Categories [ Time Frame: Baseline; Week 48 ]
  6. Change From Baseline in Serum Creatinine at Week 48 in the Blinded Phase [ Time Frame: Baseline; Week 48 ]
  7. Percent Change from Baseline in Hip BMD at Week 96 in the Blinded Phase in a Subset of Participants [ Time Frame: Baseline; Week 96 ]
  8. Percent Change from Baseline in Spine BMD at Week 96 in the Blinded Phase in a Subset of Participants [ Time Frame: Baseline; Week 96 ]
  9. Assessment of Renal Biomarkers at Week 96 in the Blinded Phase: Percent Change From Baseline in Urine Beta-2-Microglobulin to Creatinine Ratio [ Time Frame: Baseline; Week 96 ]
  10. Assessment of Renal Biomarkers at Week 96 in the Blinded Phase: Percent Change From Baseline in Urine RBP to Creatinine Ratio [ Time Frame: Week 96 ]
  11. Assessment of Renal Biomarkers at Week 96 in the Blinded Phase: Distribution of UP and UPCR categories [ Time Frame: Week 96 ]
  12. Change From Baseline in Serum Creatinine at Week 96 in the Blinded Phase [ Time Frame: Week 96 ]
  13. Incidence of Treatment-Emergent Adverse Events [ Time Frame: At least 144 weeks plus 30 days ]
  14. Incidence of Treatment-Emergent Laboratory Toxicities [ Time Frame: At least 144 weeks plus 30 days ]
  15. Incidence of HIV-1 Infection per 100 PY [ Time Frame: When all participants have 96 weeks of follow-up after randomization ]

    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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Men and Transgender Women
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842086


  Hide Study Locations
Locations
United States, California
Beverly Hills, California, United States, 90211
Los Angeles, California, United States, 90036
Los Angeles, California, United States, 90069
Newport Beach, California, United States, 92663
Oakland, California, United States, 94609
Sacramento, California, United States, 95817
Sacramento, California, United States, 95825
San Diego, California, United States, 92103
San Francisco, California, United States, 94102
San Francisco, California, United States, 94103
San Francisco, California, United States, 94118
Torrance, California, United States, 90502
United States, Colorado
Aurora, Colorado, United States, 80045
Denver, Colorado, United States, 80209
United States, Connecticut
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Washington, District of Columbia, United States, 20009
Washington, District of Columbia, United States, 20036
United States, Florida
Fort Lauderdale, Florida, United States, 33308
Fort Lauderdale, Florida, United States, 33316
Fort Pierce, Florida, United States, 34982
Miami, Florida, United States, 33136
Orlando, Florida, United States, 32803
Pensacola, Florida, United States, 32504
West Palm Beach, Florida, United States, 33401
United States, Georgia
Atlanta, Georgia, United States, 30308
Atlanta, Georgia, United States, 30309
Atlanta, Georgia, United States, 30312
Macon, Georgia, United States, 31201
United States, Illinois
Chicago, Illinois, United States, 60612
Chicago, Illinois, United States, 60613
United States, Louisiana
New Orleans, Louisiana, United States, 70119
United States, Massachusetts
Boston, Massachusetts, United States, 02215
Springfield, Massachusetts, United States, 01105
United States, Michigan
Berkley, Michigan, United States, 48072
Detroit, Michigan, United States, 48202
United States, Minnesota
Minneapolis, Minnesota, United States, 55415
United States, Nevada
Las Vegas, Nevada, United States, 89104
United States, New Jersey
Somers Point, New Jersey, United States, 08244
United States, New Mexico
Santa Fe, New Mexico, United States, 87505
United States, New York
Bronx, New York, United States, 10467
New York, New York, United States, 10029
New York, New York, United States, 10037
New York, New York, United States, 10065
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599-7215
Huntersville, North Carolina, United States, 28078
United States, Ohio
Cleveland, Ohio, United States, 44109
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Austin, Texas, United States, 78705
Dallas, Texas, United States, 75208
Dallas, Texas, United States, 75246
Houston, Texas, United States, 77098
United States, Washington
Seattle, Washington, United States, 98101
Seattle, Washington, United States, 98104
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53226
Austria
Graz, Austria, 8051
Vienna, Austria, 1090
Canada, British Columbia
Vancouver, British Columbia, Canada, V6Z 2T1
Canada, Ontario
Toronto, Ontario, Canada, M5G 1K2
Canada, Quebec
Montreal, Quebec, Canada, H2l 4P9
Montreal, Quebec, Canada, H2L5B1
Montréal, Quebec, Canada, H2W 1T8
Denmark
Hvidovre, Region Hovedstaden, Denmark, 2650
Aarhus N, Region Midtjylland, Denmark, 8200
Copenhagen, RegionH, Denmark, 2100
Odense, Denmark, 5000
France
Nice, Alpe Maritimes, France, 6202
Marseille, Provence, France, 13006
Paris, Provence, France, 75020
Paris cedex 10, France, 75475
Germany
Munich, Bavaria, Germany, 81675
Berlin, Germany, 10439
Berlin, Germany, 10777
Frankfurt, Germany, 60596
Ireland
Dublin 7, Dublin, Ireland, D07 A8NN
Dublin, Ireland, 8
Italy
Milan, Italy, 20127
Roma, Italy, 00149
Netherlands
Amsterdam, Netherlands
Spain
Badalona, Barcelona, Spain, 08907
Barcelona, Spain, 08015
Madrid, Spain, 28010
Vigo, Spain, 36312
United Kingdom
Soho, London, United Kingdom, W1D 6AQ
Whitechapel, London, United Kingdom, E1 1BB
Edinburgh, Scotland, United Kingdom, EH3 9HA
Brighton, Sussex, United Kingdom, BN2 1ES
Birmingham, United Kingdom, B9 5SS
London, United Kingdom, E9 6SR
London, United Kingdom, SE18 4QH
London, United Kingdom, SE5 9RJ
London, United Kingdom, W2 1NY
London, United Kingdom, WC1E 6JB
Manchester, United Kingdom, M13 0FH
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02842086     History of Changes
Other Study ID Numbers: GS-US-412-2055
2016-001399-31 ( EudraCT Number )
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Tenofovir
Emtricitabine
Infection
Communicable Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents