Etravirine Access for HIV

Recruiting in Palo Alto (17 mi)

+32 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Janssen Sciences Ireland UC

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to provide etravirine (ETR) through this trial until participants can be switched to locally available ETR-based treatment regimens (that is, commercially available and reimbursed, or accessible through another source \[example, access program or government program\]), or local standard of care, as appropriate.

Research Team

Janssen Sciences Ireland UC Clinical Trial

Principal Investigator

Janssen Sciences Ireland UC

Eligibility Criteria

This trial is for children and adults aged 2 years and older with documented HIV-1 infection who have previously benefited from Etravirine (ETR) in a pediatric clinical trial. Participants must consent to the study, not be pregnant or breastfeeding, and use effective birth control if applicable.

Inclusion Criteria

I completed a pediatric trial with ETR and it's still benefiting me.

Participant and their parent(s) or legal representative(s) have signed the Informed Consent Form (ICF)/Assent voluntarily

My child understands the study and agrees to participate.

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Exclusion Criteria

I do not have any serious health conditions that could make treatment unsafe for me.

Any condition (including but not limited to alcohol and drug use) which in the opinion of the investigator could compromise the participant's safety or adherence to treatment with ETR

I am a male, sexually active with women, not vasectomized, and not using or willing to use birth control during and 30 days post-trial.

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Treatment Details

Interventions

Etravirine (Non-nucleoside reverse transcriptase inhibitor)

Trial OverviewThe study provides continued access to Etravirine (ETR) for HIV-1 infected participants until they can switch to an available local treatment regimen or standard care. It aims to ensure ongoing treatment during the transition period.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: EtravirineExperimental Treatment1 Intervention

Etravirine Dosed by weight up to a maximum dose of 200 milligram (mg) bid until switched to an etravirine (ETR)-based treatment regimens (i.e. commercially available and reimbursed, or accessible through another source) or local standard of care, as appropriate.