Overview

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

Status:
Completed
Trial end date:
2020-06-15
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gilead Sciences
Treatments:
Antiviral Agents
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.