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NCT06970223
A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIV
Phase 1 trial testing Cabotegravir long-acting in HIV Infections in 65 participants. Participants enrolled and being followed up; not accepting new ones.
15 July 2025
Quick facts
| Lead sponsor | ViiV Healthcare |
|---|---|
| Phase | Phase 1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 65 |
| Start date | 22 April 2025 |
| Primary completion | 15 July 2025 |
| Estimated completion | 10 July 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Cabotegravir long-acting — full drug profile →
- Lenacapavir long-acting — full drug profile →
Conditions studied
- HIV Infections — all drugs for HIV Infections →
Sponsor
ViiV Healthcare — full company profile →
Who can join
18 and older, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06970223
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Cabotegravir long-acting
Trials testing the same drug.
- NCT06807736 — PrEPared to Choose (PtC) is an Implementation Study of the Delivery of Cabotegravir Long-acting, an Injectable Pre-expos · recruiting
Other recruiting trials for HIV Infections
Currently open trials in the same condition.
- NCT07225530 — Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR) · NA · recruiting
- NCT07202546 — A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) · Phase 2 · recruiting
- NCT06694753 — Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participants Without HIV and in Overall · Phase 1 · recruiting
- NCT07235852 — Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention · NA · recruiting
- NCT06665646 — Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Ad · Phase 1 · recruiting
Other ViiV Healthcare trials
Trials by the same sponsor.
- NCT07393659 — A Continued Access Study for Participants Transitioning From ViiV Healthcare-sponsored or ViiV Healthcare-collaborative · Phase 3 · not yet recruiting
- NCT07525544 — A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants · Phase 1 · not yet recruiting
- NCT07275606 — A Study to Investigate Cabotegravir for Neonates Exposed to HIV-1 · Phase 1, PHASE2 · not yet recruiting
- NCT07202546 — A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) · Phase 2 · recruiting
- NCT07053384 — A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Vir · Phase 1 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06970223 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by ViiV Healthcare
- Last refreshed: 28 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06970223.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing