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NCT06970223 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIV
A Phase 1 study of HIV Infections, sponsored by ViiV Healthcare.
- Active
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
- 1
- Study location
NCT06970223: Active Phase 1 study of HIV Infections, sponsored by ViiV Healthcare.
NCT06970223 is a Phase 1 study of HIV Infections that is active but no longer recruiting, run by ViiV Healthcare. The registered enrollment target is 65 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06970223, a Phase 1 study of HIV Infections, is active but no longer recruiting, sponsored by ViiV Healthcare.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the tolerability and acceptability of injection site reactions (ISRs) of two long-acting (LA) injectables. Additional characteristics of the ISRs will be investigated and described as well as safety outcomes.
Primary Outcome
The analysis is performed using the 21-item perception of injection (PIN) questionnaire which includes 21 items grouped into 4 multi-item domains: 'Acceptance of ISR' scale score (2 items); 'Bother from ISR' scale score (6 items); 'Leg movement' scale score (4 items); 'Sleep' scale score (4 items); and 5 standalone items: pain during injection; anxiety before injection; anxiety after injection; willingness to be injected in the future; and overall satisfaction with mode of administration. Partic
Conditions Studied
Interventions
- DRUG Lenacapavir long-acting
- DRUG Cabotegravir long-acting
Study Locations (1)
California
- GSK Investigational Site - Long Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2025-04-22 |
| Est. Completion | 2026-07-10 |
| Phase | Phase 1 |
What the registry record for NCT06970223 still lists
NCT06970223 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (85% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Lenacapavir long-acting is the first listed.
NCT06970223 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06970223 about?
NCT06970223 is a clinical study titled "A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIV". This study will evaluate the tolerability and acceptability of injection site reactions (ISRs) of two long-acting (LA) injectables. Additional characteristics of the ISRs will be investigated and described as well as safety outcomes.
What is the current status of trial NCT06970223?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2025-04-22. Estimated completion is 2026-07-10.
What conditions does trial NCT06970223 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT06970223?
The interventions under investigation include: Lenacapavir long-acting (DRUG), Cabotegravir long-acting (DRUG).
Who is sponsoring clinical trial NCT06970223?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06970223 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06970223's enrollment target sits among peer trials
65 320th of 542 higher than 223 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections 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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