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Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With Other Antiretroviral Agents in People Living With HIV

NCT04143594 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2024-10-02

Study results available
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Summary

The primary objective of this study is to evaluate the efficacy of lenacapavir (formerly GS-6207) containing regimens in people living with human immunodeficiency virus (HIV) (PLWH).

Conditions

Interventions

DRUG

Oral Lenacapavir

Tablets administered without regard to food

DRUG

F/TAF

Tablets administered without regard to food

DRUG

Subcutaneous Lenacapavir

Administered in the abdomen via subcutaneous injections

DRUG

TAF

Tablets administered without regard to food

DRUG

BIC

Tablets administered without regard to food

DRUG

B/F/TAF

Tablets administered without regard to food

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-22
Primary Completion
2021-10-05
Completion
2023-09-19
FDA Drug
Yes

Countries

  • United States
  • Dominican Republic
  • Puerto Rico

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 NCT04143594 on ClinicalTrials.gov