NCT05418868 is a Phase 1 clinical trial of Cabotegravir 200 mg/mL in HIV Infections, sponsored by ViiV Healthcare.

Who is sponsoring NCT05418868?

NCT05418868 is sponsored by ViiV Healthcare.

What drugs are being tested in NCT05418868?

Interventions in NCT05418868: Cabotegravir 200 mg/mL, Cabotegravir >=400 mg/mL, Cabotegravir Formulation I, CAB Formulation J, rHuPH20, RPV.

What condition does NCT05418868 study?

NCT05418868 studies HIV Infections.

Is NCT05418868 still recruiting?

NCT05418868 is currently recruiting now. Last updated 18 December 2025.

Last reviewed 2025-12-18 · How we verify

NCT05418868

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants

Recruiting now Phase 1 Last updated 18 December 2025

What this trial tests

Phase 1 trial testing Cabotegravir 200 mg/mL in HIV Infections in 214 participants. Currently enrolling.

Timeline

14 June 2022

Primary endpoint
8 June 2027

8 June 2027

Quick facts

Lead sponsor	ViiV Healthcare
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	214
Start date	14 June 2022
Primary completion	8 June 2027
Estimated completion	8 June 2027
Sites	3 locations across United States

Drugs / interventions tested

Cabotegravir 200 mg/mL — full drug profile →
Cabotegravir >=400 mg/mL
Cabotegravir Formulation I — full drug profile →
CAB Formulation J — full drug profile →
rHuPH20 — full drug profile →
RPV

Conditions studied

HIV Infections — all drugs for HIV Infections →

Sponsor

ViiV Healthcare — full company profile →

Who can join

Adults 18 to 55, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open-label, dose-escalation study to investigate the safety, tolerability and pharmacokinetics (PK) of single subcutaneous (SC) administration of long acting (LA) Cabotegravir (CAB) 200 milligrams per milliliter (mg/mL) with Recombinant Human Hyaluronidase PH20 (rHuPH20) (Part A), a single-dose or repeat-dose SC or intramuscular (IM) administration of LA CAB (greater than or equal to) \>=400 mg/mL (Part C), single-dose IM administration of LA CAB Formulation I (Part C Cohort C8) and LA CAB Formulation J (Part C Cohort C11), and a single-dose or repeat-dose IM administration of rilpivirine (RPV) (Part E). Part A of the study (CAB 200 mg/mL with rHuPh20) has been closed to further enrolment based on preliminary results. Part D of the study (CAB \>=400 mg/mL with rHuPH20) will not be conducted due to changes in the study design.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

From permeation enhancer to therapeutic enabler: Advances, applications, and translational perspectives in hyaluronidase-based drug delivery.
Seo Y, Sung J, Lee JY. · · 2026 · PMID 41960159 · DOI 10.1016/j.mtbio.2026.103052

Verify or expand the search:

Other trials of Cabotegravir 200 mg/mL

Trials testing the same drug.

NCT04484337 — Study to Evaluate Pharmacokinetic (PK), Safety and Tolerability of Cabotegravir (CAB) 400 Milligrams Per Milliliter (mg/ · Phase 1 · completed

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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05418868 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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: 18 December 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/NCT05418868.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing