At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
Oral Lenacapavir +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1b Randomized, Blinded, Proof-of-Concept Study to Evaluate the Safety and Efficacy of Broadly Neutralizing Antibodies (bNAbs) GS-5423 and GS-2872 in Combination With Capsid Inhibitor Lenacapavir (GS-6207) in Virologically Suppressed Adults With HIV-1 Infection
In Brief
A Phase 1 clinical trial evaluating Oral Lenacapavir, Subcutaneous Lenacapavir, and 2 other interventions for HIV-1 Infection. Completed, enrolled 32 participants across 23 sites.
Detailed Summary
The primary objective of this study is to evaluate the safety and tolerability of a combination of the broadly neutralizing antibodies (bNAbs) teropavimab (formerly GS-5423) and zinlirvimab (formerly GS-2872) in combination with the HIV capsid inhibitor lenacapavir (LEN).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
First PostedMar 2021
Enrollment StartApr 2021
Primary CompletionJun 2022
Study CompletionOct 2023
TodayJul 2026
First PostedMar 23, 2021
Enrollment StartApr 8, 2021
Primary CompletionJun 9, 2022
Study CompletionOct 26, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 5.3 years ago
Interventions
Oral Lenacapavirdrug
Tablets administered without regard to food
Subcutaneous Lenacapavirdrug
Administered in the abdomen via subcutaneous injections
Teropavimabdrug
Administered intravenously
Zinlirvimabdrug
Administered intravenously