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An Operationally Seamless Phase 2/3, Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of GS-1720 in Combination With GS-4182 Versus Biktarvy in Treatment-Naive People With HIV-1
The goal of this clinical study is to learn more about the experimental drugs GS-1720 (an oral, long-acting integrase strand transfer inhibitor (INSTI)) and GS-4182 (a prodrug of Lenacapavir (LEN)); to compare the combination of GS-1720 and GS-4182 with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (Biktarvy), to see if the combination of GS-1720 and GS-4182 is safe and if it works for treating human immunodeficiency virus type 1 (HIV-1) infection in treatment-naive people with HIV-1 (PWH). This study has two phases: Phase 2 and Phase 3. The primary objectives of this study are: Phase 2: To evaluate the efficacy of oral weekly GS-1720 coadministered with GS-4182 versus continuing Biktarvy (BVY) in treatment-naive PWH at Week 24. Phase 3: To evaluate the efficacy of oral weekly GS-1720/GS-4182 fixed-dose combination (FDC) tablet regimen versus continuing BVY in treatment-naive PWH at Week 48.
View MoreAge
18 Years +
Sex
ALL
Healthy Volunteers
No
Medical Condition
HIV-1-infection
Gender
N/A
Date
October 2024 - January 2029
Study Type
INTERVENTIONAL
Study Phase
PHASE2, PHASE3
Product
GS-1720, GS-4182, Bictegravir/emtricitabine/tenofovir alafenamide, GS-1720/GS-4182 FDC, Placebo to Match BVY, Placebo to Match GS1720/GS-4182 FDC
Birmingham, Alabama, United States, 35222
Torrance, California, United States, 90502
West Hollywood, California, United States, 90046
Washington, District of Columbia, United States, 20007
DeLand, Florida, United States, 32720
Fort Pierce, Florida, United States, 34982
Miami Lakes, Florida, United States, 33016
Orlando, Florida, United States, 32803
West Palm Beach, Florida, United States, 33407
Atlanta, Georgia, United States, 30308
Macon, Georgia, United States, 31201
Newark, New Jersey, United States, 07102
New York, New York, United States, 10016
Charleston, South Carolina, United States, 29425
Bellaire, Texas, United States, 77401
Dallas, Texas, United States, 75208
Dallas, Texas, United States, 75246
Fort Worth, Texas, United States, 76104
San Antonio, Texas, United States, 78229
Spokane, Washington, United States, 99202
Montreal, Canada, H2L 4P9
Ottawa, Canada, K1H 8L6
Bonn, Germany, 53127
Hamburg, Germany, 20146
Hannover, Germany, 30625
Munchen, Germany, 81675
Gdansk, Poland, 80-172
Amadora, Portugal, 2720- 276
Lisboa, Portugal, 1649-035
Porto, Portugal, 4050
Porto, Portugal, 4200-319
San Juan, Puerto Rico, 00909
San Juan, Puerto Rico, 00935
Bucharest, Romania, 021105
Bucharest, Romania
Cluj-Napoca, Romania, 400003
Constanta, Romania, 00709
Bloemfontein, South Africa, 9301
East London, South Africa, 5217
East London, South Africa, 5241
Germiston, South Africa, 1401
Johannesburg, South Africa, 2038
KwaZulu-Natal, South Africa, 4449
Tembisa, South Africa, 1632
Barcelona, Spain, 8036
Malaga, Spain, 29010
Pontevedra, Spain, 36312
Valencia, Spain, 46015
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