NCT03739866

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

A Phase 1b Randomized, Double-Blinded, Placebo Controlled, Multi-Cohort Study of the Safety, Pharmacokinetics, and Antiviral Activity of GS-6207 Administered Subcutaneously in HIV-1 Infected Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	Lenacapavir	Administered subcutaneously in the abdomen
DRUG	Placebo	Administered subcutaneously in the abdomen
DRUG	B/F/TAF	50/200/25 mg tablets administered orally once daily
DRUG	TAF	Tablets administered orally

Timeline

• Start date: 2018-11-26
• Primary completion: 2019-11-14
• Completion: 2020-06-15
• First posted: 2018-11-14
• Last updated: 2021-04-09
• Results posted: 2020-12-09

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study