Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV
Public ClinicalTrials.gov record NCT05052996. 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 Randomized, Open-Label, Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to evaluate the efficacy of oral weekly islatravir (ISL) in combination with lenacapavir (LEN) in virologically suppressed people with HIV (PWH) at Week 24.
Study identification
- NCT ID
- NCT05052996
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 142 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 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
- Oct 5, 2021 (Actual)
- Primary completion
- Dec 19, 2023 (Actual)
- Completion
- Mar 2028 (Estimated)
- Last update posted
- Feb 4, 2026
2021 – 2028
United States locations
- U.S. sites
- 44
- U.S. states
- 20
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pacific Oaks Medical Group | Beverly Hills | California | 90211 | — |
| Ruane Clinical Research Group, Inc | Los Angeles | California | 90036 | — |
| Mills Clinical Research | Los Angeles | California | 90069 | — |
| Hoag Medical Group - Newport Beach | Newport Beach | California | 92663 | — |
| BIOS Clinical Research | Palm Springs | California | 92262 | — |
| Optimus Medical Group | San Francisco | California | 94102 | — |
| Public Health Institute at Denver Health | Denver | Colorado | 80204 | — |
| Vivent Health | Denver | Colorado | 80246 | — |
| Washington Health Institute | Washington D.C. | District of Columbia | 20017 | — |
| The George Washington University Medical Faculty Associates Inc. | Washington D.C. | District of Columbia | 20037 | — |
| CAN Community Health Care, Inc. | Fort Lauderdale | Florida | 33316 | — |
| Midway Immunology and Research Center | Ft. Pierce | Florida | 34982 | — |
| JEM Research Institute | Lake Worth | Florida | 33462 | — |
| Schiff Center for Liver Diseases/University of Miami | Miami | Florida | 33136 | — |
| Floridian Clinical Research | Miami Lakes | Florida | 33016 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| Emory University Hospital Midtown Infectious Disease Clinic | Atlanta | Georgia | 30308 | — |
| Atlanta ID Group, PC | Atlanta | Georgia | 30309 | — |
| Metro Infectious Disease Consultants | Decatur | Georgia | 30033 | — |
| Chatham County Health Department | Savannah | Georgia | 31401 | — |
| John A. Burns School of Medicine, University of Hawaii Clinics at Kaka'ako | Honolulu | Hawaii | 96813 | — |
| Howard Brown Health Center | Chicago | Illinois | 60613 | — |
| Northstar Healthcare | Chicago | Illinois | 60657 | — |
| Indiana CTSI Clinical Research Center | Indianapolis | Indiana | 46202 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| AccessHealth MA | Boston | Massachusetts | 02129 | — |
| Be Well Medical Center | Berkley | Michigan | 48072 | — |
| Hennepin Healthcare HCMC | New Brighton | Minnesota | 55112 | — |
| Southampton Healthcare, Inc. | St Louis | Missouri | 63139 | — |
| Huntridge Family Clinic | Las Vegas | Nevada | 89104 | — |
| ID Care | Hillsborough | New Jersey | 08844 | — |
| AXCES Research Group | Santa Fe | New Mexico | 87505 | — |
| New York-Presbyterian Queens | Flushing | New York | 11355 | — |
| Jacobi Medical Center | The Bronx | New York | 10461 | — |
| NC TraCS Institute - CTRC: University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Penn Medicine: Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Philadelphia FIGHT Community Health Centers | Philadelphia | Pennsylvania | 19107 | — |
| Central Texas Clinical Research, LLC | Austin | Texas | 78705 | — |
| AIDS Arms Inc | Dallas | Texas | 75208 | — |
| North Texas Infectious Diseases Consultants, P.A. | Dallas | Texas | 75246 | — |
| The Crofoot Research Center, INC | Houston | Texas | 77098 | — |
| Peter Shalit, M.D. | Seattle | Washington | 98104 | — |
| MultiCare Rockwood Main Clinic | Spokane | Washington | 99202 | — |
| Community Health Care | Tacoma | Washington | 98405 | — |
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 NCT05052996, 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 Feb 4, 2026 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05052996 live on ClinicalTrials.gov.