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NCT06012136 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Suspension Injection of Investigational Capsid Inhibitors Compared to Placebo in Healthy Adults
A Phase 1 study of HIV Infections, sponsored by ViiV Healthcare.
- Active
- Registry status
- Phase 1
- Development phase
- 85
- Enrollment target
- 2
- Study locations
NCT06012136: Active Phase 1 study of HIV Infections, sponsored by ViiV Healthcare.
NCT06012136 is a Phase 1 study of HIV Infections that is active but no longer recruiting, run by ViiV Healthcare. The registered enrollment target is 85 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (81% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06012136, a Phase 1 study of HIV Infections, is active but no longer recruiting, sponsored by ViiV Healthcare.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 85 participants
- Enrollment target
- 2
- Study locations
Study Summary
The primary purpose of the study is to investigate safety and tolerability following single and multiple ascending subcutaneous (SC) and intramuscular (IM) doses of capsid inhibitors in healthy participants. The study will also describe the pharmacokinetics following single and multiple ascending SC and IM doses of capsid inhibitors in healthy participants.
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. Severity of Adverse Event will be assessed using Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS). DAIDS grading scale is used to grade the toxicity associated with injection site reactions (ISR) including injection site pain (or tenderness), erythema (or redn
Conditions Studied
Interventions
- DRUG Placebo
- DRUG VH4004280
- DRUG VH4011499
Study Locations (2)
Nevada
- GSK Investigational Site - Las Vegas
Texas
- GSK Investigational Site - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2023-08-24 |
| Est. Completion | 2026-06-09 |
| Phase | Phase 1 |
What the registry record for NCT06012136 still lists
NCT06012136 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (81% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06012136 reports a single indexed study location in Nevada, Texas.
Frequently Asked Questions
What is clinical trial NCT06012136 about?
NCT06012136 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Suspension Injection of Investigational Capsid Inhibitors Compared to Placebo in Healthy Adults". The primary purpose of the study is to investigate safety and tolerability following single and multiple ascending subcutaneous (SC) and intramuscular (IM) doses of capsid inhibitors in healthy participants. The study will also describe the pharmacokinetics following single and multiple ascending SC...
What is the current status of trial NCT06012136?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 85 participants. The study started on 2023-08-24. Estimated completion is 2026-06-09.
What conditions does trial NCT06012136 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT06012136?
The interventions under investigation include: Placebo (DRUG), VH4004280 (DRUG), VH4011499 (DRUG).
Who is sponsoring clinical trial NCT06012136?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06012136 being conducted?
This trial has 2 study locations across Nevada, 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 NCT06012136's enrollment target sits among peer trials
85 294th of 542 higher than 248 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
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