Status:
ACTIVE_NOT_RECRUITING
Study of Oral Weekly GS-1720 and GS-4182 Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed
Lead Sponsor:
Gilead Sciences
Conditions:
HIV-1-Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The goal of this clinical study is to learn more about the experimental drugs GS-1720 and GS-4182; to compare the combination of GS-1720 and GS-4182 with the current standard-of-care treatment bictegr...
Eligibility Criteria
Inclusion
- Key
- Documented plasma HIV-1 RNA \< 50 copies/mL for ≥ 24 weeks before and at screening.
- Receiving BVY for ≥ 24 weeks prior to screening.
- Key
Exclusion
- Prior use of, or exposure to LEN, GS-1720, or GS-4182.
- 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.
Key Trial Info
Start Date :
August 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
675 Patients enrolled
Trial Details
Trial ID
NCT06544733
Start Date
August 20 2024
End Date
June 1 2029
Last Update
January 5 2026
Active Locations (39)
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1
UAB 1917 Research Clinic
Birmingham, Alabama, United States, 35294
2
Pacific Oaks Medical Group
Beverly Hills, California, United States, 90211
3
Ruane Clinical Research Group
Los Angeles, California, United States, 90036
4
Mills Clinical Research
Los Angeles, California, United States, 90069