Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance
← catalyst calendarSponsored by Gilead Sciences (industry) · GILD — their whole pipeline →.
Phase
Phase 2/3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
72actual
Sites
75
Countries
Canada, Dominican Republic, France +8
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2019-11-21 | actual | When the study began enrolling |
| Primary completion | 2020-10-05 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jan 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2019-11-04 | actual | When this record first appeared on the registry |
| Results posted | 2021-10-20 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-03-13 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- HIV-1-infection
Interventions
- Drug: Oral Lenacapavir — also filed as Sunlenca®, GS-6207
- Drug: Oral Lenacapavir Placebo
- Drug: Subcutaneous Lenacapavir — also filed as Sunlenca®, GS-6207
- Drug: Failing ARV Regimen
- Drug: Optimized Background Regimen (OBR)
Primary outcome
what the primary-completion date above is the date OFPercentage of Participants in Cohort 1 Achieving a Reduction of ≥ 0.5 log10 Copies/mL in Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) From Baseline to the End of Functional Monotherapy Period
measured Baseline up to Day 1 SC Visit (14 days after the first dose of oral lencapavir) or Day 15
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol: Amendment 2posted 2020-09-01 · 4.8 MB · Prot_004.pdf
Study Protocol: Amendment 5posted 2024-05-22 · 1.6 MB · Prot_005.pdf
Statistical Analysis Plan: Primary Efficacy Endpoint Analysisposted 2020-09-30 · 1.3 MB · SAP_002.pdf
Statistical Analysis Plan: Week 26 Interim Analysisposted 2021-04-19 · 2.3 MB · SAP_003.pdf
Statistical Analysis Plan: Year 2 and 3 analysisposted 2023-04-11 · 1.1 MB · SAP_006.pdf
Publications
- PMID 38085652 — cited as background
- PMID 37451297 — cited as background
- PMID 36082606 — cited as background
- PMID 35544387 — cited as background
- PMID 41459297 — cited as background
- PMID 39873394 — cited as background
- PMID 39912752 — cited as background
- PMID 39206943 — cited as background
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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