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

Gilead Sciences

Status and phase

Completed

Phase 1

Conditions

HIV-1 Infection

Treatments

Drug: B/F/TAF

Drug: TAF

Drug: Lenacapavir

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03739866

GS-US-200-4072

Details and patient eligibility

About

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.

Enrollment

53 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Plasma HIV-1 RNA ≥ 5,000 copies/mL but ≤ 400,000 copies/mL and CD4+ cell count > 200 cells/mm^3
Treatment naive or experienced but CAI (for Part A only) and integrase strand transfer inhibitor (INSTI) naïve, and have not received any antiretroviral therapy (ART) within 12 weeks of screening
Screening genotype report must show sensitivity to B/F/TAF to allow its initiation on Day 10
Screening genotype report must show sensitivity to at least one agent in either non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI) class to allow its use as part of standard of care oral antiretroviral treatment in the future
Have adequate renal function (estimated glomerular filtration rate ≥ 70 mL/min)
No clinically significant abnormalities in electrocardiography (ECG) at Screening
Willing to initiate B/F/TAF on Day 10 after completion of all assessments

Key Exclusion Criteria:

Pregnant or lactating females

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

53 participants in 8 patient groups, including a placebo group

Part A: Lenacapavir 20 mg

Experimental group

Description:

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.

Treatment:

Drug: Lenacapavir

Drug: B/F/TAF

Part A: Lenacapavir 50 mg

Experimental group

Description:

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.

Treatment:

Drug: Lenacapavir

Drug: B/F/TAF

Part A: Lenacapavir 150 mg

Experimental group

Description:

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.

Treatment:

Drug: Lenacapavir

Drug: B/F/TAF

Part A: Lenacapavir 450 mg

Experimental group

Description:

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.

Treatment:

Drug: Lenacapavir

Drug: B/F/TAF

Part A: Lenacapavir 750 mg

Experimental group

Description:

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.

Treatment:

Drug: Lenacapavir

Drug: B/F/TAF

Part A: Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: B/F/TAF

Part B: TAF 200 mg

Experimental group

Description:

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.

Treatment:

Drug: B/F/TAF

Drug: TAF

Part B: TAF 600 mg

Experimental group