Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy
Public ClinicalTrials.gov record NCT07682961. 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 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Switching to Long-acting Antiretroviral Therapy of Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab in Combination With the Capsid Inhibitor Lenacapavir Twice-Yearly Versus Cabotegravir and Rilpivirine Every 8 Weeks in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The goal of this clinical study is to compare how effective a long-acting injectable treatment of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) versus (CAB) and rilpivirine (RPV) injections given every 8 weeks in adults with HIV-1 whose virus is well controlled on daily oral treatment, after 1 year (52 weeks) of the treatment. The primary objective of this study are to evaluate the efficacy of switching to the regimen of LEN, TAB, and ZAB versus switching to CAB and RPV in virologically suppressed people with HIV-1 (PWH) as determined by the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52.
Study identification
- NCT ID
- NCT07682961
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 590 participants
Conditions and interventions
Conditions
Interventions
- Lenacapavir Drug
- Lenacapavir Tablet Drug
- Teropavimab Drug
- Zinlirvimab Drug
- Cabotegravir Drug
- Rilpivirine Drug
Drug
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
- Jul 13, 2026
- Primary completion
- Feb 28, 2029
- Completion
- Feb 28, 2033
- Last update posted
- Aug 13, 2026
2026 – 2033
United States locations
- U.S. sites
- 16
- U.S. states
- 8
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Optimus Medical Group | San Francisco | California | 94102 | Recruiting |
| Midland Florida Clinical Research Center, LLC | DeLand | Florida | 32720 | Recruiting |
| CAN Community Health Fort Lauderdale | Fort Lauderdale | Florida | 33316 | Recruiting |
| Midway Immunology and Research Center | Ft. Pierce | Florida | 34982 | Recruiting |
| CAN Community Health Miami Gardens | Miami Gardens | Florida | 33055 | Recruiting |
| BLISS Health Inc. | Orlando | Florida | 32803 | Recruiting |
| MOORE Clinical Research, Inc d/b/a TrueBlue Clinical Research | Tampa | Florida | 33614 | Recruiting |
| Triple O Research Institute, P.A. | West Palm Beach | Florida | 33407 | Recruiting |
| Atlantic Clinical Research Institute | West Palm Beach | Florida | 33409 | Recruiting |
| Atlanta ID Group, PC | Atlanta | Georgia | 30309 | Recruiting |
| Chatham County Health Department | Savannah | Georgia | 31401 | Recruiting |
| Be Well Medical Center | Berkley | Michigan | 48072 | Recruiting |
| KC CARE Health Center | Kansas City | Missouri | 64111 | Recruiting |
| North Texas Infectious Diseases Consultants, P.A. | Dallas | Texas | 75246 | Recruiting |
| Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID) | Annandale | Virginia | 22003 | Recruiting |
| TribalMed PLLC | Seattle | Washington | 98104 | Recruiting |
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 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07682961, 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 Aug 13, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07682961 live on ClinicalTrials.gov.