← Back to Search

Other

Loestrin + VH4524184 for Human Immunodeficiency Virus Infection

Phase 1

Recruiting

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 from day -28 (run-in-period) up to approximately 2 months (day 28 +/- 3 days)

Awards & highlights

Study Summary

This trial will look at how VH4524184 affects the way the body processes a specific type of birth control pill in healthy women.

Who is the study for?

This trial is for healthy adult women who are not pregnant, breastfeeding, or trying to become pregnant. Participants must be willing to take an oral contraceptive and the study drug VH4524184.Check my eligibility

What is being tested?

The study is testing whether taking a new medication called VH4524184 affects how well a common birth control pill (Loestrin) works in preventing pregnancy.See study design

What are the potential side effects?

Possible side effects may include those commonly associated with birth control pills such as nausea, headaches, mood changes, and spotting between periods. The new drug's side effects aren't detailed here.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day -28 (run-in-period) up to approximately 2 months (day 28 +/- 3 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day -28 (run-in-period) up to approximately 2 months (day 28 +/- 3 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day -28 (run-in-period) up to approximately 2 months (day 28 +/- 3 days) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

AUC0-Tau, ss of EE and NEA with coadministration with VH4524184

Area under the concentration-time curve (AUC) from time zero (pre-dose) to the end of the dosing interval at steady state (AUC0-Tau, ss) of EE and NEA without coadministration with VH4524184

Cmax for EE and NEA with coadministration with VH4524184

+1 more

Secondary outcome measures

Area under the concentration-time curve from time zero(pre-dose) to the end of the dosing interval at steady state (AUC0-Tau, ss) for VH4524184

Change from baseline of liver panel laboratory parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ASP) (International units per liter)

Change from baseline of liver panel laboratory parameters: International normalized ratio (INR) (Ratio)

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Loestrin + VH4524184Experimental Treatment2 Interventions

Eligible participants entering a run-in period of 21 days (Days -28 through -8) will receive Loestrin (EE and NEA) to stabilize on the combined OCs containing EE and NEA to synchronize the menstrual cycles of multiple participants. Participants completing the run-in period will enter Treatment Period 1 and will be administered Loestrin once daily from Days 1 to 10. On Day 11, participants will enter Treatment Period 2 and will be administered Loestrin + VH4524184 once daily from Days 11 to 20.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Loestrin

2022

Completed Phase 1

~140

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ViiV HealthcareLead Sponsor

360 Previous Clinical Trials

468,554 Total Patients Enrolled

Frequently Asked Questions

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

What is the current number of participants being recruited for this medical research study?

"Affirmative, data from clinicaltrials.gov indicates that this research study is presently in the recruitment phase. The trial was first listed on 3/6/2024 and had its most recent update on 3/7/2024. Researchers aim to enroll 25 participants at a single designated site."

Answered by AI

Has the combination of Loestrin and VH4524184 received approval from the FDA?

"The safety rating for the combination of Loestrin and VH4524184 is marked as 1 by our team at Power. This low score reflects the early Phase 1 trial stage, where only preliminary data on safety and effectiveness are available."

Answered by AI

Is the clinical trial open to individuals younger than 65 years of age?

"Prospective candidates for this research study must fall within the age bracket of 18 to 45 years. There are a total of 108 trials focused on individuals under 18 and 329 studies targeting those above the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Investigate the Potential Drug-Drug Interaction Between VH4524184 and Oral Contraceptive (Loestrin) in Healthy Adult Female Participants

2024. "A Study to Investigate the Potential Drug-Drug Interaction Between VH4524184 and Oral Contraceptive (Loestrin) in Healthy Adult Female Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06310616.

All > Pflugerville Tx > Paid Studies Austin