Etravirine Access for HIV

Recruiting at 32 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Sciences Ireland UC

Must be taking: Etravirine

Disqualifiers: Pregnancy, Breastfeeding, Cardiac dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: Up to 10 years and 11 months

180 Participants Needed

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial investigator to understand how your current medications might interact with etravirine.

Is etravirine safe for humans?

Etravirine is generally well tolerated and has a good safety record in humans. The most common side effect is a mild to moderate rash, which usually resolves with continued use. Other side effects like nausea and vomiting are possible, but serious issues are rare. ^{1 2 3 4 5}

How is the drug Etravirine unique for treating HIV?

Etravirine is unique because it is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used specifically for patients who have already been treated with other HIV medications and are experiencing treatment failure. It is often combined with a ritonavir-boosted protease inhibitor to enhance its effectiveness in these treatment-experienced individuals. ^{5 6 7 8 9}

What data supports the effectiveness of the drug etravirine for HIV treatment?

Research shows that etravirine, when added to a combination of other HIV drugs, helps improve the control of the virus in patients who have been heavily treated before. It has been found to provide better virus suppression and improve immune system health compared to not using it, and it is generally well tolerated with the main side effect being a rash. ^{7 10 11 12 13}

Who Is on the Research Team?

Janssen Sciences Ireland UC Clinical Trial

Principal Investigator

Janssen Sciences Ireland UC

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

Treatment

Participants continue to receive etravirine (ETR) based on weight-adjusted dosing until they can switch to a locally available ETR-based treatment regimen or local standard of care.

Up to 10 years and 11 months

Assessment visits every 3 months (pediatric) and 6 months (adults)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Etravirine

Trial Overview The 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.

How Is the Trial Designed?

Group I: Etravirine Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Janssen Sciences Ireland UC

Lead Sponsor

Trials

28

Recruited

2,700+

Published Research Related to This Trial

In a 48-week study involving 211 HIV-1-infected patients, etravirine (200 mg twice daily) was found to be well tolerated, with diarrhea being the most common side effect (17%), and serious adverse events were not related to etravirine.

The virologic response rates at week 48 showed that 48% of patients with a baseline viral load of ≥50 copies/mL achieved viral suppression (<50 copies/mL), while 75% of those with a baseline viral load of <50 copies/mL responded well, highlighting the importance of adherence to treatment for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Etravirine combined with antiretrovirals other than darunavir/ritonavir for HIV-1-infected, treatment-experienced adults: Week 48 results of a phase IV trial. Arathoon, E., Bhorat, A., Silaghi, R., et al.[2020]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Impact of etravirine on hospitalization rate between 2005 and 2011 among heavily treated HIV-1-infected individuals on failing regimens. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Short communication: high effectiveness of etravirine in routine clinical practice in treatment-experienced HIV type 1-infected patients. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Impact of reverse transcriptase resistance on the efficacy of TMC125 (etravirine) with two nucleoside reverse transcriptase inhibitors in protease inhibitor-naïve, nonnucleoside reverse transcriptase inhibitor-experienced patients: study TMC125-C227. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Etravirine combined with antiretrovirals other than darunavir/ritonavir for HIV-1-infected, treatment-experienced adults: Week 48 results of a phase IV trial. [2020]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Etravirine: a review of its use in the management of treatment-experienced patients with HIV-1 infection. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

A review of the safety and tolerability profile of the next-generation NNRTI etravirine. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Etravirine: A novel nonnucleoside reverse transcriptase inhibitor for managing human immunodeficiency virus infection. [2020]

8. Spain pubmed.ncbi.nlm.nih.gov

[Safety and tolerability of etravirine]. [2020]

9. France pubmed.ncbi.nlm.nih.gov

Etravirine: new drug. Multidrug-resistant HIV: another option. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Efficacy, safety, and tolerability of etravirine with and without darunavir/ritonavir or raltegravir in treatment-experienced patients: analysis of the etravirine early access program in the United States. [2020]

11. England pubmed.ncbi.nlm.nih.gov

Outcomes of etravirine-based antiretroviral treatment in treatment-experienced children and adolescents living with HIV in Europe and Thailand. [2023]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of etravirine use on hospitalization rates among highly pre-treated failing HIV-1 infected individuals between 2005 and 2011. [2018]

13. England pubmed.ncbi.nlm.nih.gov

Long-term efficacy and safety of etravirine-containing regimens in a real-life cohort of treatment-experienced HIV-1-infected patients. [2020]