Clinical Trials in Japan / NCT04150068
Active, not recruiting
Phase 2/3
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
NCT04150068 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
HIV-1-infection
Investigational drug(s) / intervention(s)
Oral Lenacapavir →Oral Lenacapavir PlaceboSubcutaneous Lenacapavir →Failing ARV RegimenOptimized Background Regimen (OBR)
Oral Lenacapavir: Tablets administered without regard to food
Oral Lenacapavir Placebo: Tablets administered without regard to food
Subcutaneous Lenacapavir: Administered in the abdomen via subcutaneous injections
Failing ARV Regimen: Failing antiretroviral (ARV) regimen defined by the lack of efficacy. Any combination of approved and unapproved agents that could potentially be part of the failing regimen.
Optimized Background Regimen (OBR): Optimized background regimen as prescribed by the Investigator
Study summary
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).
Eligibility
Key Inclusion Criteria:
* Adult aged ≥ 18 years (at all sites) or adolescent aged ≥ 12 and weighing ≥ 35 kg (at sites in North America and Dominican Republic)
* Currently receiving a stable failing ARV regimen for \> 8 weeks
* Have HIV-1 RNA ≥ 400 copies/mL at screening
* Have multidrug resistance (resistance to ≥2 agents from ≥3 of the 4 main classes of ARV)
* Have no more than 2 fully active ARV remaining from the 4 main classes that can be effectively combined to form a viable regimen
* Able and willing to receive an OBR together with lenacapavir
* No Hepatitis C virus (HCV) ongoing infection
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Primary outcome measure(s)
- Percentage of Participants in Cohort 1 Achieving a Reduction of ≥ 0.5 log10 Copies/mL in Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) From Baseline to the End of Functional Monotherapy Period — Baseline up to Day 1 SC Visit (14 days after the first dose of oral lencapavir) or Day 15
Trial sites (75)
| Facility | City | Region | Status |
|---|---|---|---|
| Ruane Clinical Research Group Inc | Los Angeles | California | |
| Mills Clinical Research | Los Angeles | California | |
| Eisenhower Health Center at Rimrock | Palm Springs | California | |
| One Community Health | Sacramento | California | |
| Yale University; School of Medicine | New Haven | Connecticut | |
| Washington Health Institute | Washington D.C. | District of Columbia | |
| Midland Florida Clinical Research Center, LLC | DeLand | Florida | |
| Gary J. Richmond, M.D., P.A. | Fort Lauderdale | Florida | |
| Midway Immunology and Research Center | Ft. Pierce | Florida | |
| Floridian Clinical Research | Hialeah | Florida | |
| AIDS Healthcare Foundation - South Beach | Miami Beach | Florida | |
| Orlando Immunology Center | Orlando | Florida | |
| St. Joseph's Hospital Comprehensive Research Institute | Tampa | Florida | |
| Triple O Research Institute, P.A. | West Palm Beach | Florida | |
| Emory Hospital Midtown Infectious Disease Clinic | Atlanta | Georgia | |
| Atlanta ID Group, PC | Atlanta | Georgia | |
| Chatham County Health Department | Savannah | Georgia | |
| Howard Brown Health Center | Chicago | Illinois | |
| Northstar Healthcare | Chicago | Illinois | |
| Be Well Medical Center | Berkley | Michigan | |
| Southampton Healthcare, Inc. | St Louis | Missouri | |
| New York-Presbyterian/Queens | Flushing | New York | |
| North Shore University Hospital/Division of Infectious Diseases | Manhasset | New York | |
| Jacobi Medical Center | The Bronx | New York | |
| Atrium Health- Infectious Disease Consultants | Charlotte | North Carolina | |
| Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | |
| The Miriam Hospital | Providence | Rhode Island | |
| 1265 Union Avenue, 8 East | Memphis | Tennessee | |
| Central Texas Clinical Research | Austin | Texas | |
| St Hope Foundation | Bellaire | Texas | |
| AIDS Arms, Inc. DBA Prism Health North Texas | Dallas | Texas | |
| North Texas Infectious Diseases Consultants, P.A. | Dallas | Texas | |
| The Crofoot Research Center, INC. | Houston | Texas | |
| DCOL Center for Clinical Research | Longview | Texas | |
| Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID) | Annandale | Virginia | |
| Vancouver ID Research and Care Centre Society | Vancouver | British Columbia | |
| Maple Leaf Research/Maple Leaf Medical Clinic | Toronto | Ontario | |
| Clinique de médecine urbaine du Quartier Latin | Montreal | Quebec | |
| The Ottawa Hospital | Ottawa | Canada | |
| Instituto Dominicano de Estudios Virologicos (IDEV) | Santo Domingo | Dominican Republic |
+ 35 more sites — see the full list on the official registry below.
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04150068 on ClinicalTrials.gov ↗ ← All trials in Japan