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A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
NCT05418868 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Cabotegravir 200 mg/mL
- DRUG Cabotegravir >=400 mg/mL
- DRUG Cabotegravir Formulation I
- DRUG CAB Formulation J
- DRUG rHuPH20
Study Locations (3)
Florida
- GSK Investigational Site — Orlando
Nevada
- GSK Investigational Site — Las Vegas
Texas
- GSK Investigational Site — Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2022-06-14 |
| Est. Completion | 2027-06-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05418868
The ClinicalTrials.gov registry entry for NCT05418868 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 214 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 82 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 5 interventions — of which Cabotegravir 200 mg/mL is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05418868 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Florida, Nevada, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05418868 about?
NCT05418868 is a clinical study titled "A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants". 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 singl...
What is the current status of trial NCT05418868?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 214 participants. The study started on 2022-06-14. Estimated completion is 2027-06-08.
What conditions does trial NCT05418868 study?
This clinical trial studies the following conditions: HIV Infections. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05418868?
The interventions under investigation include: Cabotegravir 200 mg/mL (DRUG), Cabotegravir >=400 mg/mL (DRUG), Cabotegravir Formulation I (DRUG), CAB Formulation J (DRUG), rHuPH20 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05418868?
This trial is sponsored by ViiV Healthcare, which has 82 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05418868 being conducted?
This trial has 3 study locations across Florida, Nevada, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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