Study Details - Gilead Clinical Trials

OVERVIEW

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 (DISCOVER)

PROTOCOL 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.

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

true

Medical Condition

Pre-Exposure Prophylaxis of HIV-1 Infection

Gender

Men and Transgender Women

Date

September 2016 - January 2019

Study Type

INTERVENTIONAL

Study Phase

PHASE3

Product

F/TAF, F/TDF, F/TAF Placebo, F/TDF Placebo

Eligibility Information

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

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.

Locations

Locations (93)

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

Aurora, Colorado, United States, 80045

Denver, Colorado, United States, 80209

New Haven, Connecticut, United States, 06510

Washington, District of Columbia, United States, 20009

Washington, District of Columbia, United States, 20036

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, 33407

Atlanta, Georgia, United States, 30308

Atlanta, Georgia, United States, 30309

Atlanta, Georgia, United States, 30312

Macon, Georgia, United States, 31201

Chicago, Illinois, United States, 60612

Chicago, Illinois, United States, 60613

New Orleans, Louisiana, United States, 70119

Boston, Massachusetts, United States, 02215

Springfield, Massachusetts, United States, 01105

Berkley, Michigan, United States, 48072

Detroit, Michigan, United States, 48202

Minneapolis, Minnesota, United States, 55415

Las Vegas, Nevada, United States, 89104

Somers Point, New Jersey, United States, 08244

Santa Fe, New Mexico, United States, 87505

Bronx, New York, United States, 10467

New York, New York, United States, 10029

New York, New York, United States, 10032

New York, New York, United States, 10037

Chapel Hill, North Carolina, United States, 27599-7215

Huntersville, North Carolina, United States, 28078

Cleveland, Ohio, United States, 44109

Philadelphia, Pennsylvania, United States, 19107

Austin, Texas, United States, 78705

Dallas, Texas, United States, 75208

Dallas, Texas, United States, 75246

Houston, Texas, United States, 77098

Seattle, Washington, United States, 98101

Seattle, Washington, United States, 98104

Milwaukee, Wisconsin, United States, 53226

Graz, Austria, 8051

Vienna, Austria, 1090

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

Hvidovre, Region Hovedstaden, Denmark, 2650

Aarhus N, Region Midtjylland, Denmark, 8200

Copenhagen, RegionH, Denmark, 2100

Odense, Denmark, 5000

Nice, Alpe Maritimes, France, 6202

Marseille, Provence, France, 13006

Paris, Provence, France, 75020

Paris cedex 10, France, 75475

Munich, Bavaria, Germany, 81675

Berlin, Germany, 10439

Berlin, Germany, 10777

Frankfurt, Germany, 60596

Dublin 7, Dublin, Ireland, D07 A8NN

Dublin, Ireland, 8

Milan, Italy, 20127

Roma, Italy, 00149

Amsterdam, Netherlands

Badalona, Barcelona, Spain, 08907

Barcelona, Spain, 08015

Madrid, Spain, 28010

Vigo, Spain, 36312

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