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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: Completed Phase 1 study of HIV-1-infection, sponsored by Gilead Sciences.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Maximum reduction is defined as the minimum of change from baseline in plasma HIV-1 RNA (i.e. smallest change in HIV-RNA from baseline).
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 |
What the finished NCT03739866 record still lists
NCT03739866 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (85% lower).
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 lists 12 locations in 4 states (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.
Learn More About Clinical Trials
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Where NCT03739866's enrollment target sits among peer trials
53 48th of 71 higher than 24 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1-infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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