Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Lenacapavir Administered Subcutaneously in Human Immunodeficiency Virus (HIV) -1 Infected Adults
Completed · Phase 1 · Has a placebo group
Conditions studied: HIV-1 Infection
In brief
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.
Key facts
- Study ID
- NCT03739866
- Run by
- Gilead Sciences
- People needed
- 53
- Starts
- 2018-11-26
- Expected to finish
- 2020-06-15
- Last updated by the study team
- 2021-04-09
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Ruane Clinical Research Group, Inc. — Los Angeles, California, United States
- Mills Clinical Research — Los Angeles, California, United States
- One Community — Sacramento, California, United States
- The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States
- Midway Immunology and Research Center — Ft. Pierce, Florida, United States
- Orlando Immunology Center PA — Orlando, Florida, United States
- Triple O Research Institute, P.A. — West Palm Beach, Florida, United States
- Be Well Medical Center — Berkley, Michigan, United States
- AIDS Arms, Inc., DBA Prism Health North Texas — Dallas, Texas, United States
- North Texas Infectious Diseases Consultants, P.A. — Dallas, Texas, United States
- Tarrant County Infectious Disease Associates — Fort Worth, Texas, United States
- The Crofoot Research Center, INC (dba Gordon E. Crofoot MD PA) — Houston, Texas, United States
Full record on ClinicalTrials.gov
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