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Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Lenacapavir Administered Subcutaneously in Human Immunodeficiency Virus (HIV) -1 Infected Adults
NCT03739866 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03739866 reports 12 study locations spanning 4 distinct geographic areas — top geographies include California, Texas, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03739866?
The interventions under investigation include: Placebo (DRUG), TAF (DRUG), Lenacapavir (DRUG), B/F/TAF (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03739866?
This trial is sponsored by Gilead Sciences, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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