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NCT04484337 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate Pharmacokinetic (PK), Safety and Tolerability of Cabotegravir (CAB) 400 Milligrams Per Milliliter (mg/mL) Formulation in Healthy Adult Participants
A Phase 1 study of HIV Infections, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 138
- Enrollment target
- 5
- Study locations
NCT04484337: Completed Phase 1 study of HIV Infections, sponsored by ViiV Healthcare.
NCT04484337 is a Phase 1 study of HIV Infections that has completed, run by ViiV Healthcare. The registered enrollment target is 138 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (69% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04484337, a Phase 1 study of HIV Infections, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 138 participants
- Enrollment target
- 5
- Study locations
Study Summary
This is an active control, randomized study to investigate the safety, tolerability and PK of repeat dose administration of long-acting CAB 400 mg/mL formulation intramuscular (IM) (gluteus medius and vastus lateralis) and subcutaneous (SC) (abdominal) injections in healthy adult participants.
Primary Outcome
Blood samples were collected for Pharmacokinetic (PK) analysis of CAB. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.
Conditions Studied
Interventions
- DRUG Cabotegravir 200 mg/mL
- DRUG Cabotegravir sodium (Oral Lead In)
- DRUG Cabotegravir 400 mg/mL
- DRUG Topical non-steroidal anti-inflammatory drug
- DRUG Topical steroid
Study Locations (5)
Florida
- GSK Investigational Site - Orlando
Nevada
- GSK Investigational Site - Las Vegas
New Jersey
- GSK Investigational Site - Berlin
Texas
- GSK Investigational Site - Austin
Other
- GSK Investigational Site - Auckland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2020-07-31 |
| Est. Completion | 2023-05-05 |
| Phase | Phase 1 |
What the finished NCT04484337 record still lists
NCT04484337 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (69% 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.
NCT04484337 lists 5 locations in 5 states (Florida, Nevada, New Jersey).
Frequently Asked Questions
What is clinical trial NCT04484337 about?
NCT04484337 is a clinical study titled "Study to Evaluate Pharmacokinetic (PK), Safety and Tolerability of Cabotegravir (CAB) 400 Milligrams Per Milliliter (mg/mL) Formulation in Healthy Adult Participants". This is an active control, randomized study to investigate the safety, tolerability and PK of repeat dose administration of long-acting CAB 400 mg/mL formulation intramuscular (IM) (gluteus medius and vastus lateralis) and subcutaneous (SC) (abdominal) injections in healthy adult participants.
What is the current status of trial NCT04484337?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 138 participants. The study started on 2020-07-31. Estimated completion is 2023-05-05.
What conditions does trial NCT04484337 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT04484337?
The interventions under investigation include: Cabotegravir 200 mg/mL (DRUG), Cabotegravir sodium (Oral Lead In) (DRUG), Cabotegravir 400 mg/mL (DRUG), Topical non-steroidal anti-inflammatory drug (DRUG), Topical steroid (DRUG).
Who is sponsoring clinical trial NCT04484337?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04484337 being conducted?
This trial has 5 study locations across Florida, Nevada, New Jersey, Texas. 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 NCT04484337's enrollment target sits among peer trials
138 223rd of 542 higher than 320 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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