Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Lenacapavir Administered Subcutaneously in Human Immunodeficiency Virus (HIV) -1 Infected Adults
Status:Completed
Phase:I
Principal Investigator(s):
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 U=U
Study Design:Double-blind, Placebo-controlled, Randomized
Arms and Assigned Interventions
DescriptionExperimental: 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 DeliverySubcutaneous, Tablet
ARMsExperimental
DescriptionExperimental: 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 DeliverySubcutaneous, Tablet
ARMsExperimental
DescriptionExperimental: 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 DeliverySubcutaneous, Tablet
ARMsExperimental
DescriptionExperimental: 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 DeliverySubcutaneous, Tablet
ARMsExperimental
DescriptionExperimental: 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 DeliverySubcutaneous, Tablet
ARMsExperimental
Official Code:
NCT03739866
Trial Sponsors:
Gilead
Start Date
End Date
November 26, 2018
June 15, 2020
Enrollment:53
Age range:
18 Years ↔
65 Years
Population:Cisgender Men