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NCT05418868 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
A Phase 1 study of HIV Infections, sponsored by ViiV Healthcare.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 214
- Enrollment target
- 3
- Study locations
NCT05418868: Recruiting Phase 1 study of HIV Infections, sponsored by ViiV Healthcare.
NCT05418868 is a Phase 1 study of HIV Infections that is actively recruiting participants, run by ViiV Healthcare. The registered enrollment target is 214 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (52% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05418868, a Phase 1 study of HIV Infections, is actively recruiting participants, sponsored by ViiV Healthcare.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 214 participants
- Enrollment target
- 3
- Study locations
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 |
What NCT05418868 shows while recruiting
NCT05418868 is an interventional study that assigns participants to a tested intervention. The registered 214 participants enrollment target is mid-sized for trials with a published cap, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (52% lower).
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.
NCT05418868 reports a single indexed study location in Florida, Nevada, Texas.
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.
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).
Who is sponsoring clinical trial NCT05418868?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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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 NCT05418868's enrollment target sits among peer trials
214 163rd of 542 higher than 380 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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