Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06310551 · ClinicalTrials.gov registry record · Phase 1
First Time in Human Study of Long Acting VH4524184 Formulations
A Phase 1 study of HIV Infections, sponsored by ViiV Healthcare.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 268
- Enrollment target
- 2
- Study locations
NCT06310551: Recruiting Phase 1 study of HIV Infections, sponsored by ViiV Healthcare.
NCT06310551 is a Phase 1 study of HIV Infections that is actively recruiting participants, run by ViiV Healthcare. The registered enrollment target is 268 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (40% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06310551, a Phase 1 study of HIV Infections, is actively recruiting participants, sponsored by ViiV Healthcare.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 268 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to identify 1 or more doses of parenterally administered VH4524184 that are safe, well tolerated and yield a PK drug exposure profile necessary to deliver a long-acting antiretroviral therapy for the treatment of HIV-1 infection.
Primary Outcome
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Related AE = AE assessed by the investigator as related to the study drug.
Conditions Studied
Interventions
- DRUG rHuPH20
- DRUG Oral VH4524184
- DRUG VH4524184 Formulation A SC
- DRUG Placebo Formulation A SC
- DRUG VH4524184 Formulation B SC
Study Locations (2)
Kansas
- GSK Investigational Site - Lenexa
Texas
- GSK Investigational Site - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 268 participants |
| Start Date | 2024-03-21 |
| Est. Completion | 2028-01-21 |
| Phase | Phase 1 |
What NCT06310551 shows while recruiting
NCT06310551 is an interventional study that assigns participants to a tested intervention. The registered 268 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 (40% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 5 interventions - of which rHuPH20 is the first listed.
NCT06310551 reports a single indexed study location in Kansas, Texas.
Frequently Asked Questions
What is clinical trial NCT06310551 about?
NCT06310551 is a clinical study titled "First Time in Human Study of Long Acting VH4524184 Formulations". The purpose of this study is to identify 1 or more doses of parenterally administered VH4524184 that are safe, well tolerated and yield a PK drug exposure profile necessary to deliver a long-acting antiretroviral therapy for the treatment of HIV-1 infection.
What is the current status of trial NCT06310551?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 268 participants. The study started on 2024-03-21. Estimated completion is 2028-01-21.
What conditions does trial NCT06310551 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT06310551?
The interventions under investigation include: rHuPH20 (DRUG), Oral VH4524184 (DRUG), VH4524184 Formulation A SC (DRUG), Placebo Formulation A SC (DRUG), VH4524184 Formulation B SC (DRUG).
Who is sponsoring clinical trial NCT06310551?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06310551 being conducted?
This trial has 2 study locations across Kansas, 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 NCT06310551's enrollment target sits among peer trials
268 133rd of 542 higher than 410 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
CAR-T Cells for HIV Infection
RECRUITING · Phase 1
-
A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV
RECRUITING · Phase 1
-
Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Adult Participants Who Previously Participated in HVTN 706
RECRUITING · Phase 1
-
Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics
RECRUITING · Phase 1
-
A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
RECRUITING · Phase 1
-
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of VH4011499 Compared to Placebo in Adults Without HIV
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05000632 · 268 participants · NA
Smoke Free SafeCare: Establishing a Smoke Free Home in CPS-involved Families
- NCT05797831 · 268 participants · Phase 2
Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer
- NCT05997381 · 268 participants · NA
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
- NCT06233461 · 268 participants · Phase 2
A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI