CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 142 enrolled
Drug / intervention
ISL +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.

Search/NCT05052996
NCT05052996Phase 2Active
CompareCT.gov

A Phase 2 Randomized, Open-Label, Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV

Gilead Sciences·interventional·Posted Sep 22, 2021·Updated Feb 4, 2026

In Brief

A Phase 2 clinical trial evaluating ISL, LEN, and 2 other interventions for HIV-1 Infection. Active but no longer recruiting, targeting 142 participants across 44 sites.

Detailed Summary

The primary objective of this study is to evaluate the efficacy of oral weekly islatravir (ISL) in combination with lenacapavir (LEN) in virologically suppressed people with HIV (PWH) at Week 24.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 2Active
2022202320242025202620272028
First PostedSep 22, 2021
Enrollment StartOct 5, 2021
Primary CompletionDec 19, 2023
Study CompletionMar 1, 2028
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 4.8 years ago

Interventions

ISLdrug

Capsules administered orally without regard to food

LENdrug

Tablets administered orally without regard to food

B/F/TAFdrug

Tablets administered orally without regard to food

ISL/LEN FDCdrug

Tablets administered orally without regard to food