OVERVIEW
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 Virologically Suppressed People With HIV-1 (WONDERS1)
PROTOCOL SUMMARY
The goal of this clinical study is to learn more about the experimental drugs lepetegravir and lenacapavir pacfosacil; to compare the combination of lepetegravir and lenacapavir pacfosacil with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF, BVY), to see if the combination of lepetegravir and lenacapavir pacfosacil is safe and if it works for treating human immunodeficiency virus type 1 (HIV-1) infection. This study has two phases: Phase 2 and Phase 3. The primary objectives of this study are: Phase 2: To evaluate the efficacy of switching to oral weekly lepetegravir in combination with lenacapavir pacfosacil versus continuing BVY in virologically suppressed people with HIV-1 (PWH) at Week 24. Phase 3: To evaluate the efficacy of switching to oral weekly lepetegravir /lenacapavir pacfosacil Fixed-dose combination (FDC) tablet regimen versus continuing BVY in virologically suppressed PWH at Week 48.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
HIV-1-Infection
Gender
N/A
Date
August 2024 - January 2028
Study Type
Interventional
Study Phase
Phase 2, Phase 3
Product
Lepetegravir, Lenacapavir pacfosacil, Placebo to Match BVY, Bictegravir/emtricitabine/tenofovir alafenamide, Lepetegravir/Lenacapavir pacfosacil FDC, Placebo to Match GS1720/GS-4182 FDC
Eligibility information
Inclusion criteria
- Documented plasma HIV-1 RNA < 50 copies/mL for ≥ 24 weeks before and at screening.
- Receiving BVY for ≥ 24 weeks prior to screening.
Exclusion criteria
- Prior use of, or exposure to LEN, lepetegravir, or lenacapavir pacfosacil.
- History of virologic failure while on an integrase strand-transfer inhibitor (INSTI)-based regimen.
- Documented integrase strand-transfer inhibitor (INSTI) resistance, specifically, resistance-associated mutations (RAMs) E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene.
- Prior use of any long-acting (LA) parenteral antiretrovirals (ARV) such as monoclonal antibodies (mAbs) or broadly neutralizing antibodies (bNAbs) targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine.
- Any of the following laboratory values at screening:
- Clusters of differentiation 4 (CD4) cell count < 200 cells/mm^3 at screening
- Glomerular filtration rate < 60 mL/min according to the Modification of Diet in Renal Disease formula
- Hepatic transaminases (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 1.5 × upper limit of normal (ULN)
- Direct bilirubin > 1.5 × ULN
- Platelets count < 50,000 cells/mm^3
- Hemoglobin < 8.0 g/dL
- Active or occult hepatitis B virus (HBV) infection.
- Active hepatitis C virus (HCV).
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (39)
Pacific Oaks Medical Group
Beverly Hills, California, United States, 90211
Ruane Clinical Research Group
Los Angeles, California, United States, 90036
Mills Clinical Research
Los Angeles, California, United States, 90069
BIOS Clinical Research
Palm Springs, California, United States, 92262
UCSF Division of HIV, Infectious Diseases & Global Medicine
San Francisco, California, United States, 94110
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
Midland Florida Clinical Research Center, LLC
DeLand, Florida, United States, 32720
Midway and Immunology Research Center
Ft. Pierce, Florida, United States, 34982
AIDS Healthcare Foundation - The Kinder Medical Group
Miami, Florida, United States, 33133
Floridian Clinical Research
Miami Lakes, Florida, United States, 33016
Triple O Research Institute, P.A.
West Palm Beach, Florida, United States, 33407
Metro Infectious Disease Consultants, P.L.L.C.
Decatur, Georgia, United States, 30033
Mercer University, Department of Internal Medicine
Macon, Georgia, United States, 31201
Chatham County Health Department
Savannah, Georgia, United States, 31401
Saint Michael's Medical Center
Newark, New Jersey, United States, 07102
NYU Langone Health Vaccine Center
New York, New York, United States, 10016
Rosedale Health and Wellness
Huntersville, North Carolina, United States, 28078
Prism Health North Texas, Oak Cliff Health Center
Dallas, Texas, United States, 75215
North Texas Infectious Diseases Consultants, PA
Dallas, Texas, United States, 75246
Texas Centers for Infectious Disease Associates
Fort Worth, Texas, United States, 76104
The Crofoot Research Center, INC.
Houston, Texas, United States, 77098
DCOL Center for Clinical Research
Longview, Texas, United States, 75605
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