Etravirine Access for HIV

Not currently recruiting at 39 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to provide continued access to etravirine for people living with HIV. It is designed for those who have completed a related pediatric trial and are benefiting from etravirine. Participants must have a documented HIV-1 infection and have experienced positive outcomes from past use of this medication. Those who have found etravirine helpful may find this trial suitable. As a Phase 3 trial, it represents the final step before FDA approval, offering an opportunity to contribute to the treatment's potential availability to a wider population.

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 there any evidence suggesting that etravirine is likely to be safe for humans?

Research has shown that etravirine is generally safe for people. Studies involving over 1,200 participants found that many can use this treatment without issues. It is already approved for adults who haven't had success with other HIV medications. Most side effects, such as rash and nausea, are mild, and serious side effects are rare. This suggests that etravirine is a safe option for those considering joining a clinical trial for HIV treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for HIV?

Etravirine is unique because it offers a different approach to treating HIV compared to many standard options like efavirenz or nevirapine. Unlike these treatments, which often come with a higher risk of side effects, etravirine is known for its better safety profile, particularly in terms of fewer central nervous system side effects. Additionally, etravirine can be dosed based on weight, providing a more personalized treatment option. Researchers are excited about etravirine because it remains effective in many patients with resistant strains of HIV, offering hope for those who have limited options due to drug resistance.

What is the effectiveness track record for etravirine in treating HIV?

Research has shown that etravirine, the treatment under study in this trial, effectively treats HIV in individuals who have previously tried other treatments. Studies indicate that more than two-thirds of patients with extensive treatment history managed to control the virus after 12 months. Etravirine effectively reduces the virus in the blood. In another study, about 60% of patients taking etravirine had virus levels so low after 48 weeks that they couldn't be measured in their blood. Overall, etravirine is not only effective but also generally safe for patients. ^{5 6 7 8 9}

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

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

Negative urine pregnancy test for females of childbearing potential

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

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7614682/

Outcomes of etravirine-based antiretroviral treatment in ... Children receiving ETR were predominantly highly treatment-experienced, over two-thirds were virally suppressed at 12 months. Introduction. Second- and third- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3603589/

Patterns of Use and Outcomes in Patients Treated with ... To date, ETR has demonstrated high efficacy rates, as well as good tolerability and safety profiles [1, 2].

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00959894?intr=R-165335&aggFilters=studyType:int&viewType=Table&rank=1&tab=results

Study Results | Evaluating Once Daily Etravirine in ... Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-1: 24-week results from a randomised, double-blind ...

4. natap.org natap.org/2008/CROI/croi_34.htm

New 48-Week Efficacy and Safety Data Presented for ... In the DUET-1 and -2 studies, 60 percent and 61 percent of patients in the INTELENCE arms had a confirmed undetectable viral load at 48 weeks ...

5. thelancet.com thelancet.com/journals/lancet/article/PIIS0140673607610484/abstract

Efficacy and safety of TMC125 (etravirine) in treatment- ... In treatment-experienced patients, treatment with TMC125 led to better virological suppression at week 24 than did placebo. The safety and tolerability profile ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2009/022187s002lbl.pdf

1 etravirine – 14.2.3 Final Labeling Text - accessdata.fda.gov The safety assessment is based on all data from 1203 subjects in the ongoing Phase 3 placebo-controlled trials,. TMC125-C206 and TMC125-C216, conducted in ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2817788/

Profile of etravirine for the treatment of HIV infection - PMC Etravirine has demonstrated activity against some strains of virus resistant to other NNRTIs,8 and is approved for use in treatment-experienced adult patients.

8. ema.europa.eu ema.europa.eu/en/medicines/human/EPAR/intelence

Intelence | European Medicines Agency (EMA) After 24 weeks, 59% of the patients taking Intelence together with other HIV medicines had undetectable levels of HIV, compared with 41% of those taking placebo ...

9. mayoclinic.org mayoclinic.org/drugs-supplements/etravirine-oral-route/description/drg-20071513

Etravirine (oral route) - Side effects & dosage Etravirine will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow the destruction of the immune ...