Clinical Trials

MainTitle

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)

This study is ongoing, but not recruiting participants.
Sponsor
Gilead Sciences


Information provided by (Responsible Party)
Gilead Sciences
ClinicalTrials.gov Identifier
NCT02842086

First received: July 20, 2016
Last updated: July 11, 2017
Last Verified: July 2017
History of Changes
Purpose

Purpose

The primary objective of this study is to assess the rates of HIV-1 seroconversion 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.

Condition Intervention 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
Study Design: 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

Further study details as provided by Gilead Sciences:

Primary Outcome Measures

  • Incidence of Seroconversions per 100 Person Years (PY) as Defined by the HIV-1 RNA by Polymerase Chain Reaction (PCR) [ Time Frame: When the last participant has a minimum of 48 weeks of follow-up and at least 50% of the participants have at least 96 weeks of follow-up after randomization ]
Secondary Outcome Measures:
  • 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 ]
  • Percent Change From Baseline in Spine BMD at Week 48 in the Blinded Phase in a Subset of Participants [ Time Frame: Baseline; Week 48 ]
  • Percent Change From Baseline in Renal Biomarkers of Urine Retinol-Binding Protein (RBP) to Creatinine Ratio at Week 48 in the Blinded Phase [ Time Frame: Baseline; Week 48 ]
  • Percent Change From Baseline in Renal Biomarkers of Beta-2-Microglobulin to Creatinine Ratio at Week 48 in the Blinded Phase [ Time Frame: Baseline; Week 48 ]
  • Percent Change From Baseline in Renal Biomarkers of Urine Protein-to-Creatinine Ratio (UPCR) at Week 48 in the Blinded Phase [ Time Frame: Baseline; Week 48 ]
  • Change From Baseline in Serum Creatinine at Week 48 in the Blinded Phase [ Time Frame: Baseline; Week 48 ]
  • Incidence of Seroconversions per 100 PY as Defined by the HIV RNA-1 by PCR at the end of the Blinded Phase [ Time Frame: At least 96 weeks ]
  • Percent Change from Baseline in Hip BMD at Week 96 in the Blinded Phase in a Subset of Participants [ Time Frame: Baseline; Week 96 ]
  • Percent Change from Baseline in Spine BMD at Week 96 in the Blinded Phase in a Subset of Participants [ Time Frame: Baseline; Week 96 ]
  • Percent Change From Baseline in Renal Biomarkers of Urine RBP to Creatinine Ratio at Week 96 in the Blinded Phase [ Time Frame: Baseline; Week 96 ]
  • Percent Change From Baseline in Renal Biomarkers of Urine Beta-2-Microglobulin to Creatinine Ratio at Week 96 in the Blinded Phase [ Time Frame: Week 96 ]
  • Percent Change From Baseline in Renal Biomarkers of Urine Protein-to-Creatinine Ratio (UPCR) at Week 96 in the Blinded Phase [ Time Frame: Week 96 ]
  • Change From Baseline in Serum Creatinine at Week 96 in the Blinded Phase [ Time Frame: Week 96 ]
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: At least 144 weeks plus 30 days ]
  • Incidence of Treatment-Emergent Laboratory Toxicities [ Time Frame: At least 144 weeks plus 30 days ]

Enrollment: 5400
Study Start Date: September 2, 2016
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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.
Drug: F/TAF

200/25 mg tablet administered orally once daily

Other Name: Descovy®
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02842086

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, D.C., District of Columbia, United States, 20009
Washington, D.C., 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, 02115
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
New York, New York, United States, 10029
New York, New York, United States, 10037
New York, New York, United States, 10065
The Bronx, New York, United States, 10467
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
Vancouver, British Columbia, Canada, V6Z 2T1
Toronto, Ontario, Canada, M5G 1K2
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
Marseilles, 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
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
West Midlands, United Kingdom, B9 5SS

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director: Gilead Study Director Gilead Sciences
More Information

More Information


Responsible Party: Gilead Sciences  
ClinicalTrials.gov Identifier: NCT02842086   History of Changes  
Other Study ID Numbers: GS-US-412-2055  
  2016-001399-31  
Study First Received: July 20, 2016  
Last Updated: July 11, 2017  

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

ClinicalTrials.gov processed this data on December 08, 2017
This information is provided by ClinicalTrials.gov.