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Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Lenacapavir Administered Subcutaneously in Human Immunodeficiency Virus (HIV) -1 Infected Adults

Status
Completed
Phase
I
Objective
The primary objectives of this study are:

Part A: To evaluate the short-term antiviral activity of lenacapavir (formerly GS-6207) with respect to the maximum reduction of plasma HIV-1 RNA (log10 copies/mL) from Day 1 through Day 10 compared to placebo in HIV-1 infected adults who are antiretroviral treatment naive or are experienced but capsid inhibitor (CAI) naive.

Part B: To evaluate the short-term antiviral activity of tenofovir alafenamide (TAF) with respect to the maximum reduction of plasma HIV-1 RNA (log10 copies/mL) from Day 1 through Day 10 in HIV-1 infected adult subjects who are antiretroviral treatment naïve or are experienced but without resistance to TAF.

Last updated September 30, 2021
Prevention Option(s)
Treatment
Study Design
Placebo-controlled
Randomized
Double-blind
Arms and Assigned Interventions
Description
Experimental: Part A: Lenacapavir 20 mg Participants will receive single dose of lenacapavir 20 mg on Day 1 followed by bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) as per standard-care therapy starting on Day 10 through Day 225. Drug: Lenacapavir Administered subcutaneously in the abdomen Other Name: GS-6207 Drug: B/F/TAF 50/200/25 mg tablets administered orally once daily Other Name: Biktarvy®
Mode of Delivery
Subcutaneous
Tablet
Products
Lenacapavir
ARMs
Experimental
Description
Experimental: Part A: Lenacapavir 50 mg Participants will receive single dose of lenacapavir 50 mg on Day 1 followed by B/F/TAF as per standard-care therapy starting on Day 10 through Day 225. Drug: Lenacapavir Administered subcutaneously in the abdomen Other Name: GS-6207 Drug: B/F/TAF 50/200/25 mg tablets administered orally once daily Other Name: Biktarvy®
Mode of Delivery
Subcutaneous
Tablet
Products
Lenacapavir
ARMs
Experimental
Description
Experimental: Part A: Lenacapavir 150 mg Participants will receive single dose of lenacapavir 150 mg on Day 1 followed by B/F/TAF as per standard-care therapy starting on Day 10 through Day 225. Drug: Lenacapavir Administered subcutaneously in the abdomen Other Name: GS-6207 Drug: B/F/TAF 50/200/25 mg tablets administered orally once daily Other Name: Biktarvy®
Mode of Delivery
Subcutaneous
Tablet
Products
Lenacapavir
ARMs
Experimental
Description
Experimental: Part A: Lenacapavir 450 mg Participants will receive single dose of lenacapavir 450 mg on Day 1 followed by B/F/TAF as per standard-care therapy starting on Day 10 through Day 225. Drug: Lenacapavir Administered subcutaneously in the abdomen Other Name: GS-6207 Drug: B/F/TAF 50/200/25 mg tablets administered orally once daily Other Name: Biktarvy®
Mode of Delivery
Subcutaneous
Tablet
Products
Lenacapavir
ARMs
Experimental
Description
Experimental: Part A: Lenacapavir 750 mg Participants will receive single dose of lenacapavir 750 mg on Day 1 followed by B/F/TAF as per standard-care therapy starting on Day 10 through Day 225. Drug: Lenacapavir Administered subcutaneously in the abdomen Other Name: GS-6207 Drug: B/F/TAF 50/200/25 mg tablets administered orally once daily Other Name: Biktarvy®
Mode of Delivery
Subcutaneous
Tablet
Products
Lenacapavir
ARMs
Experimental
Description
Placebo Comparator: Part A: Placebo Participants will receive single dose of placebo matched to lenacapavir on Day 1 followed by B/F/TAF as per standard-care therapy starting on Day 10 through Day 225. Drug: Placebo Administered subcutaneously in the abdomen Drug: B/F/TAF 50/200/25 mg tablets administered orally once daily Other Name: Biktarvy®
Mode of Delivery
Subcutaneous
Tablet
ARMs
Placebo Comparator
Description
Experimental: Part B: TAF 200 mg Participants will receive a single dose of TAF 200 mg on Day 1 followed by B/F/TAF as per standard-care therapy starting on Day 10 through Day 225. Drug: B/F/TAF 50/200/25 mg tablets administered orally once daily Other Name: Biktarvy® Drug: TAF Tablets administered orally
Mode of Delivery
Tablet
ARMs
Experimental
Description
Experimental: Part B: TAF 600 mg Participants will receive a single dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy starting on Day 10 through Day 225. Drug: B/F/TAF 50/200/25 mg tablets administered orally once daily Other Name: Biktarvy® Drug: TAF Tablets administered orally
Mode of Delivery
Tablet
ARMs
Experimental
Official Code
NCT03739866
Related Publications
Clinical targeting of HIV capsid protein with a long-acting small molecule
Trial Sponsors
Gilead Sciences
November 2018
June 2020
Date of Enrollment Completion
November 14, 2019
Enrollment
53
18
Years
65
Years
Population
Men
Sites

Ruane Clinical Research Group Inc.

Los Angeles
United States of America

Mills Clinical Research

Los Angeles
United States of America

One Community Health

Sacramento
United States of America

Midway Immunology and Research Center

Fort Pierce
United States of America

Orlando Immunology Center HVTN CRS

Orlando, Florida
United States of America

Triple O Research Institute, P.A.

West Palm Beach
United States of America

Be Well Medical Center

Berkley
United States of America

Prism Health North Texas, Oak Cliff Health Center

Dallas, Texas
United States of America

North Texas Infectious Diseases Consultants, P.A.

Dallas
United States of America

Gordon E. Crofoot MD

Houston, Texas
United States of America

The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Center

Torrance
United States of America

Tarrant County Infectious Disease Associates

Fort Worth
United States of America