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Virus Therapy

VH3739937 for HIV

Phase 2

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

Treatment-naïve: No Antiretrovirals (ARVs) (in combination or monotherapy) received after the diagnosis of HIV-1 infection

Body weight ≥50.0 kilogram (kg) (110 pounds [lbs]) for men and ≥45.0 kg (99 lbs) for women and BMI for all participants within the range 18.5-35.0 kilogram per meter square (kg/m^2)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 168 hours

Awards & highlights

Study Summary

This trial is testing a new drug to see if it can fight HIV in people who haven't taken any HIV meds.

Who is the study for?

This trial is for adults who have recently been diagnosed with HIV-1 and haven't started treatment. They should be healthy otherwise, able to consent, and meet specific weight and BMI criteria. Participants must not use drugs of abuse or have certain heart conditions or liver diseases, including recent myocardial infarction or hepatitis.Check my eligibility

What is being tested?

The study tests the antiviral effects of a new drug called VH3739937 in people with HIV-1 who haven't had any prior treatments. It compares this new drug against a placebo during an initial phase before starting standard combination therapy on Study Day 8.See study design

What are the potential side effects?

While the side effects are not detailed here, common ones associated with antiviral drugs may include nausea, headache, fatigue, and potential allergic reactions. The safety profile will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I haven't taken any HIV medication since my diagnosis.

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I weigh at least 110 lbs if male, or 99 lbs if female, and my BMI is between 18.5-35.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 168 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 168 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 168 hours for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Maximum Change from Baseline in Plasma HIV-1 Ribonucleic Acid (RNA)

Secondary outcome measures

Area under the concentration-time curve from zero to 24h of VH3739937 at Day 1

Area under the concentration-time curve from zero to 24h of VH379937 at steady state

Area under the concentration-time curve of VH3739937 from zero to 168h after single dose

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Participants receiving VH3739937Experimental Treatment1 Intervention

Group II: Participants receiving PlaceboPlacebo Group1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

ViiV HealthcareLead Sponsor

359 Previous Clinical Trials

468,517 Total Patients Enrolled

GSK Clinical TrialsStudy DirectorViiV Healthcare

3,595 Previous Clinical Trials

6,143,904 Total Patients Enrolled

Frequently Asked Questions

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

Are elderly individuals over the age of 75 eligible to participate in this experiment?

"The age range for participants of this study is 18 to 65. However, there are 109 trials available for those younger than the minimum and 339 specifically tailored towards adults beyond the maximum age criteria."

Answered by AI

Are there any criteria for eligibility in this experiment?

"In order to meet the inclusion criteria for this clinical trial, one must have a human immunodeficiency virus infection and be between 18-65 years of age. A total of 26 participants are being accepted into this study."

Answered by AI

How many healthcare institutions have enrolled in this experiment?

"Currently, this research is enlisting patients from 18 different medical sites. These include Miami, West Palm Beach and Newark among others. It is advisable to pick the closest location available in order to reduce necessary travel demands for enrollees."

Answered by AI

How can potential risks be mitigated for those treated with VH3739937?

"The safety rating of VH3739937, as evaluated by our Power team, is 2. This drug has gone through Phase 2 trials and thus we have some evidence to suggest that it is safe but no data on its efficacy."

Answered by AI

Does this experiment currently have space for participants?

"As detailed on clinicaltrials.gov, enrollment in this study has been closed and is no longer recruiting participants; the trial was first published October 3rd 2023 but had its last update September 22nd of that same year. Despite the fact that recruitment for this particular experiment has ceased, there are 456 other trials actively seeking enrollees at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in in Treatment-Naive Adults Living With HIV-1

2023. "A Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in in Treatment-Naive Adults Living With HIV-1". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06061081.