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NCT05052996 · ClinicalTrials.gov registry record · Phase 2
Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV
A Phase 2 study of HIV-1-infection, sponsored by Gilead Sciences.
- Active
- Registry status
- Phase 2
- Development phase
- 142
- Enrollment target
- 20
- Study locations
NCT05052996: Active Phase 2 study of HIV-1-infection, sponsored by Gilead Sciences.
NCT05052996 is a Phase 2 study of HIV-1-infection that is active but no longer recruiting, run by Gilead Sciences. The registered enrollment target is 142 participants, below the 349-participant average among 71 other HIV-1-infection trials with a reported enrollment target (59% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05052996, a Phase 2 study of HIV-1-infection, is active but no longer recruiting, sponsored by Gilead Sciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 142 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with the applicable study drug discontinuation status. Week 24 window was between Day 148 and 189 (inclusive). Percentages were rounded off.
Conditions Studied
Interventions
- DRUG B/F/TAF
- DRUG ISL
- DRUG LEN
- DRUG ISL/LEN FDC
Study Locations (20)
California
- Pacific Oaks Medical Group - Beverly Hills
- Ruane Clinical Research Group, Inc - Los Angeles
- Mills Clinical Research - Los Angeles
- Hoag Medical Group - Newport Beach - Newport Beach
- BIOS Clinical Research - Palm Springs
- Optimus Medical Group - San Francisco
Florida
- CAN Community Health Care, Inc. - Fort Lauderdale
- Midway Immunology and Research Center - Ft. Pierce
- JEM Research Institute - Lake Worth
- Schiff Center for Liver Diseases/University of Miami - Miami
- Floridian Clinical Research - Miami Lakes
- Orlando Immunology Center - Orlando
Georgia
- Emory University Hospital Midtown Infectious Disease Clinic - Atlanta
- Atlanta ID Group, PC - Atlanta
- Metro Infectious Disease Consultants - Decatur
- Chatham County Health Department - Savannah
Colorado
- Public Health Institute at Denver Health - Denver
- Vivent Health - Denver
District of Columbia
- Washington Health Institute - Washington D.C.
- The George Washington University Medical Faculty Associates Inc. - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2021-10-05 |
| Est. Completion | 2028-03 |
| Phase | Phase 2 |
What the registry record for NCT05052996 still lists
NCT05052996 is an interventional study that assigns participants to a tested intervention. The registered 142 participants enrollment target is mid-sized for trials with a published cap, below the 349-participant average among 71 other HIV-1-infection trials with a reported enrollment target (59% lower).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 4 interventions - of which B/F/TAF is the first listed.
NCT05052996 names 20 study sites across 5 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT05052996 about?
NCT05052996 is a clinical study titled "Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV". 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.
What is the current status of trial NCT05052996?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 142 participants. The study started on 2021-10-05. Estimated completion is 2028-03.
What conditions does trial NCT05052996 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT05052996?
The interventions under investigation include: B/F/TAF (DRUG), ISL (DRUG), LEN (DRUG), ISL/LEN FDC (DRUG).
Who is sponsoring clinical trial NCT05052996?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05052996 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05052996's enrollment target sits among peer trials
142 24th of 71 higher than 48 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1-infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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