Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance
Public ClinicalTrials.gov record NCT04150068. 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 2/3 Study to Evaluate the Safety and Efficacy of Long-Acting Capsid Inhibitor GS-6207 in Combination With an Optimized Background Regimen in Heavily Treatment Experienced People Living With HIV-1 Infection With Multidrug Resistance
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to evaluate the antiviral activity of lenacapavir (formerly GS-6207) administered as an add-on to a failing regimen for 14 days (functional monotherapy) in people with human immunodeficiency virus type 1 (HIV-1) (PWH) with multi-drug resistance (MDR).
Study identification
- NCT ID
- NCT04150068
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 72 participants
Conditions and interventions
Conditions
Interventions
- Oral Lenacapavir Drug
- Oral Lenacapavir Placebo Drug
- Subcutaneous Lenacapavir Drug
- Failing ARV Regimen Drug
- Optimized Background Regimen (OBR) Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Years and older
- 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 21, 2019 (Actual)
- Primary completion
- Oct 5, 2020 (Actual)
- Completion
- Jan 2028 (Estimated)
- Last update posted
- Oct 1, 2026
2019 – 2028
United States locations
- U.S. sites
- 35
- U.S. states
- 15
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ruane Clinical Research Group Inc | Los Angeles | California | 90036 | — |
| Mills Clinical Research | Los Angeles | California | 90069 | — |
| Eisenhower Health Center at Rimrock | Palm Springs | California | 92264 | — |
| One Community Health | Sacramento | California | 95817 | — |
| Yale University; School of Medicine | New Haven | Connecticut | 06510 | — |
| Washington Health Institute | Washington D.C. | District of Columbia | 20017 | — |
| Midland Florida Clinical Research Center, LLC | DeLand | Florida | 32720 | — |
| Gary J. Richmond, M.D., P.A. | Fort Lauderdale | Florida | 33316 | — |
| Midway Immunology and Research Center | Ft. Pierce | Florida | 34982 | — |
| Floridian Clinical Research | Hialeah | Florida | 33016 | — |
| AIDS Healthcare Foundation - South Beach | Miami Beach | Florida | 33139 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| St. Joseph's Hospital Comprehensive Research Institute | Tampa | Florida | 33614 | — |
| Triple O Research Institute, P.A. | West Palm Beach | Florida | 33401 | — |
| Emory Hospital Midtown Infectious Disease Clinic | Atlanta | Georgia | 30308 | — |
| Atlanta ID Group, PC | Atlanta | Georgia | 30309 | — |
| Chatham County Health Department | Savannah | Georgia | 31401 | — |
| Howard Brown Health Center | Chicago | Illinois | 60613 | — |
| Northstar Healthcare | Chicago | Illinois | 60657 | — |
| Be Well Medical Center | Berkley | Michigan | 48072 | — |
| Southampton Healthcare, Inc. | St Louis | Missouri | 63139 | — |
| New York-Presbyterian/Queens | Flushing | New York | 11355 | — |
| North Shore University Hospital/Division of Infectious Diseases | Manhasset | New York | 11030 | — |
| Jacobi Medical Center | The Bronx | New York | 10461 | — |
| Atrium Health- Infectious Disease Consultants | Charlotte | North Carolina | 28209 | — |
| Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| The Miriam Hospital | Providence | Rhode Island | 02906 | — |
| 1265 Union Avenue, 8 East | Memphis | Tennessee | 38163 | — |
| Central Texas Clinical Research | Austin | Texas | 78705 | — |
| St Hope Foundation | Bellaire | Texas | 77401 | — |
| AIDS Arms, Inc. DBA Prism Health North Texas | Dallas | Texas | 75215 | — |
| North Texas Infectious Diseases Consultants, P.A. | Dallas | Texas | 75246 | — |
| The Crofoot Research Center, INC. | Houston | Texas | 77098 | — |
| DCOL Center for Clinical Research | Longview | Texas | 75605 | — |
| Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID) | Annandale | Virginia | 22003 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 40 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04150068, 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 Oct 1, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04150068 live on ClinicalTrials.gov.