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HIV-1 Capsid Inhibitor

VH4011499 for Human Immunodeficiency Virus Infection

Phase 1

Waitlist Available

Research Sponsored by ViiV Healthcare

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (day 1) and up to day 42

Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective at treating HIV-1. The study will be conducted in two parts, testing different doses of the drug.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 1) and up to day 42

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day 1) and up to day 42

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) and up to day 42 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1: Absolute values of liver panel parameters: Alanine aminotransferase (ALT), Alkaline phosphatase (ALP) and Aspartate aminotransferase (AST) (International units per Liter)

Part 1: Absolute values of liver panel parameters: Direct bilirubin, total bilirubin (Micromoles per liter)

Part 1: Area under the plasma concentration time curve from time zero to infinity (AUC[0-infinity]) following single dose administration of VH4011499

+25 more

Trial Design

7Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 3 (Single dose): Participants receiving VH4011499 (new formulation)Experimental Treatment1 Intervention

Group II: Part 2 (MAD) Non DDI cohort: Participants receiving VH4011499Experimental Treatment1 Intervention

Group III: Part 2 (MAD) Drug-Drug Interaction (DDI) cohort: Participants receiving VH4011499 + MidazolamExperimental Treatment2 Interventions

Group IV: Part 1 (SAD): Participants receiving VH4011499Experimental Treatment1 Intervention

Group V: Part 1 (SAD): Participants receiving placeboPlacebo Group1 Intervention

Group VI: Part 2 (MAD) DDI cohort: Participants receiving placebo + MidazolamPlacebo Group2 Interventions

Group VII: Part 2 (MAD) Non DDI cohort: Participants receiving placeboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VH4011499

2022

Completed Phase 1

~80

Midazolam

2018

Completed Phase 4

~1910

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ViiV HealthcareLead Sponsor

359 Previous Clinical Trials

468,470 Total Patients Enrolled

GSK Clinical TrialsStudy DirectorViiV Healthcare

3,595 Previous Clinical Trials

6,143,857 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is VH4011499 a viable option for medical treatment with minimal risk?

"Since it is only in the first phase of testing, and there has been limited data collected on safety and efficacy, VH4011499 was assessed with a score of 1."

Answered by AI

Is recruitment still available for this experiment?

"Affirmative. The details on clinicaltrials.gov point towards this trial being open for enrollment, with the initial posting occurring on May 27th 2022. Most recently updated on November 21st 2022, it is now trying to recruit 72 patients from 2 locations."

Answered by AI

How many participants are being recruited for this investigation?

"Indeed, according to clinicialtrials.gov this study is currently searching for participants. It was posted on May 27th 2022 and last updated November 21st of the same year. 72 people are needed between two sites."

Answered by AI

Does the age restriction for this clinical trial exceed twenty years?

"According to the eligibility criteria, patients can only participate if they are between 18 and 55 years old."

Answered by AI

Do I meet the criteria to partake in this medical experiment?

"This medical study is looking for 72 individuals between the age of 18 and 55 who have been diagnosed with HIV. To be considered, participants must be in good health, present two consecutive SARs-CoV-2 PCR test results indicating a negative result, weigh more than 50 kilograms (kg) and maintain body mass index (BMI) within 19-32 kg/m^2 range, not be able to bear children and give written consent prior to enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4011499 in Healthy Participants

2022. "First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4011499 in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05393271.