Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Lenacapavir Administered Subcutaneously in Human Immunodeficiency Virus (HIV) -1 Infected Adults
Public ClinicalTrials.gov record NCT03739866. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1b Randomized, Double-Blinded, Placebo Controlled, Multi-Cohort Study of the Safety, Pharmacokinetics, and Antiviral Activity of GS-6207 Administered Subcutaneously in HIV-1 Infected Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03739866
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 53 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 25, 2018
- Primary completion
- Nov 13, 2019
- Completion
- Jun 14, 2020
- Last update posted
- Apr 8, 2021
2018 – 2020
United States locations
- U.S. sites
- 12
- U.S. states
- 4
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ruane Clinical Research Group, Inc. | Los Angeles | California | 90036 | — |
| Mills Clinical Research | Los Angeles | California | 90069 | — |
| One Community | Sacramento | California | 95817 | — |
| The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Center | Torrance | California | 90502 | — |
| Midway Immunology and Research Center | Ft. Pierce | Florida | 34982 | — |
| Orlando Immunology Center PA | Orlando | Florida | 32803-1851 | — |
| Triple O Research Institute, P.A. | West Palm Beach | Florida | 33401 | — |
| Be Well Medical Center | Berkley | Michigan | 48072-3436 | — |
| AIDS Arms, Inc., DBA Prism Health North Texas | Dallas | Texas | 75208 | — |
| North Texas Infectious Diseases Consultants, P.A. | Dallas | Texas | 75246 | — |
| Tarrant County Infectious Disease Associates | Fort Worth | Texas | 76104 | — |
| The Crofoot Research Center, INC (dba Gordon E. Crofoot MD PA) | Houston | Texas | 77098 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03739866, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 8, 2021 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03739866 live on ClinicalTrials.gov.