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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

NCT04150068 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-03-13

Study results available
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Summary

The primary objective of this study is to evaluate the antiviral activity of lenacapavir (formerly GS-6207) administered as an add-on to a failing regimen for 14 days (functional monotherapy) in people with human immunodeficiency virus type 1 (HIV-1) (PWH) with multi-drug resistance (MDR).

Conditions

Interventions

DRUG

Oral Lenacapavir

Tablets administered without regard to food

DRUG

Oral Lenacapavir Placebo

Tablets administered without regard to food

DRUG

Subcutaneous Lenacapavir

Administered in the abdomen via subcutaneous injections

DRUG

Failing ARV Regimen

Failing antiretroviral (ARV) regimen defined by the lack of efficacy. Any combination of approved and unapproved agents that could potentially be part of the failing regimen.

DRUG

Optimized Background Regimen (OBR)

Optimized background regimen as prescribed by the Investigator

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-21
Primary Completion
2020-10-05
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Dominican Republic
  • France
  • Germany
  • Italy
  • Japan
  • South Africa
  • Spain
  • Taiwan
  • Thailand

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04150068 on ClinicalTrials.gov