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NCT03739866 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Lenacapavir Administered Subcutaneously in Human Immunodeficiency Virus (HIV) -1 Infected Adults
A Phase 1 study of HIV-1-infection, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 53
- Enrollment target
- 12
- Study locations
NCT03739866 is a Phase 1 study of HIV-1-infection that has completed, run by Gilead Sciences. The registered enrollment target is 53 participants, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (85% lower). The trial reports 12 study locations across 4 states.
The verdict
NCT03739866, a Phase 1 study of HIV-1-infection, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 53 participants
- Enrollment target
- 12
- Study locations
Study 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 Studied
Interventions
- DRUG Placebo
- DRUG TAF
- DRUG Lenacapavir
- DRUG B/F/TAF
Study Locations (12)
California
- Ruane Clinical Research Group, Inc. - Los Angeles
- Mills Clinical Research - Los Angeles
- One Community - Sacramento
- The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Center - Torrance
Texas
- AIDS Arms, Inc., DBA Prism Health North Texas - Dallas
- North Texas Infectious Diseases Consultants, P.A. - Dallas
- Tarrant County Infectious Disease Associates - Fort Worth
- The Crofoot Research Center, INC (dba Gordon E. Crofoot MD PA) - Houston
Florida
- Midway Immunology and Research Center - Ft. Pierce
- Orlando Immunology Center PA - Orlando
- Triple O Research Institute, P.A. - West Palm Beach
Michigan
- Be Well Medical Center - Berkley
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2018-11-26 |
| Est. Completion | 2020-06-15 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03739866
The ClinicalTrials.gov registry entry for NCT03739866 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (85% lower). The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT03739866 reports 12 study locations spanning 4 distinct geographic areas - top geographies include California, Texas, Florida.
Frequently Asked Questions
What is clinical trial NCT03739866 about?
NCT03739866 is a clinical study titled "Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Lenacapavir Administered Subcutaneously in Human Immunodeficiency Virus (HIV) -1 Infected Adults". 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...
What is the current status of trial NCT03739866?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2018-11-26. Estimated completion is 2020-06-15.
What conditions does trial NCT03739866 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT03739866?
The interventions under investigation include: Placebo (DRUG), TAF (DRUG), Lenacapavir (DRUG), B/F/TAF (DRUG).
Who is sponsoring clinical trial NCT03739866?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03739866 being conducted?
This trial has 12 study locations across California, Florida, Michigan, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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