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Non-nucleoside reverse transcriptase inhibitor

Etravirine Access for HIV

Phase 3
Waitlist Available
Research Sponsored by Janssen Sciences Ireland UC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years and 11 months
Awards & highlights

Study Summary

This trial is to provide etravirine until participants can be switched to a different, commercially available treatment.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include allergic reactions or hypersensitivity to ETR or its components, as well as any other typical drug-related adverse effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years and 11 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years and 11 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With At-least One Adverse Event as a Measure of Safety Until Etravirine (ETR)-Based Treatment Regimen is Commercially Available

Side effects data

From 2018 Phase 4 trial • 545 Patients • NCT01641367
59%
Blood sodium decreased
57%
Low density lipoprotein increased
55%
Blood cholesterol increased
34%
Blood phosphorus decreased
30%
Blood bicarbonate decreased
28%
Neutrophil count decreased
27%
Blood alkaline phosphatase increased
26%
Blood bilirubin increased
20%
Blood glucose increased
19%
Aspartate aminotransferase increased
16%
Alanine aminotransferase increased
16%
Blood potassium decreased
15%
White blood cell count decreased
14%
Blood creatinine increased
12%
Pruritus
11%
Pyrexia
11%
Haemoglobin decreased
9%
Urinary tract infection
9%
Cough
8%
Diarrhoea
8%
Blood glucose decreased
8%
Blood triglycerides increased
8%
Headache
7%
Dysuria
7%
Platelet count decreased
7%
Vaginal discharge
5%
Vulvovaginal candidiasis
5%
Back pain
5%
Blood sodium increased
5%
Arthralgia
5%
Vulvovaginal pruritus
5%
Nasal congestion
5%
Oropharyngeal pain
5%
Rhinorrhoea
5%
Rash
4%
Abdominal pain
4%
Pain
4%
Herpes zoster
4%
Decreased appetite
4%
Neuropathy peripheral
3%
Hypertension
3%
Purulent discharge
3%
Abdominal tenderness
3%
Upper respiratory tract infection
3%
Vomiting
3%
Gastroenteritis
3%
Conjunctivitis allergic
3%
Fatigue
3%
Bacterial vaginosis
3%
Blood pressure increased
3%
Pollakiuria
3%
Dyspnoea
1%
Hepatitis acute
1%
Dehydration
1%
Peptic ulcer
1%
Acute sinusitis
1%
Weight decreased
1%
Abdominal pain upper
1%
Pregnancy
1%
Costochondritis
1%
Pain in extremity
1%
Oropharyngeal plaque
1%
Pyelonephritis
1%
Osteonecrosis
1%
Cervix carcinoma
1%
Angioedema
1%
Pelvic venous thrombosis
1%
Chest pain
1%
Chills
1%
Acarodermatitis
1%
Conjunctivitis bacterial
1%
Influenza
1%
Nasopharyngitis
1%
Oral candidiasis
1%
Pneumonia bacterial
1%
Blood alkaline phosphatase abnormal
1%
Myalgia
1%
Cervical dysplasia
1%
Sinus pain
1%
Blister
1%
Erythema
1%
Anaemia megaloblastic
1%
Skin lesion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Experimental: Sub-cohort B1
Experimental: Sub-cohort B2
Experimental: Cohort C
Experimental: Sub-cohort B3
Experimental: Cohort D
Experimental: Cohort A

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etravirine
2019
Completed Phase 4
~1540

Find a Location

Who is running the clinical trial?

Janssen Sciences Ireland UCLead Sponsor
27 Previous Clinical Trials
2,528 Total Patients Enrolled
Janssen Sciences Ireland UC Clinical TrialStudy DirectorJanssen Sciences Ireland UC
22 Previous Clinical Trials
2,368 Total Patients Enrolled

Media Library

Etravirine (Non-nucleoside reverse transcriptase inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00980538 — Phase 3
Human Immunodeficiency Virus Infection Research Study Groups: Etravirine
Human Immunodeficiency Virus Infection Clinical Trial 2023: Etravirine Highlights & Side Effects. Trial Name: NCT00980538 — Phase 3
Etravirine (Non-nucleoside reverse transcriptase inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00980538 — Phase 3

Frequently Asked Questions

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

How many individuals are participating in this test?

"Currently, this trial is not enrolling new patients. The listing was created on December 9th 2009 and updated October 25th 2022. There are presently 503 studies actively recruiting patients with hiv infections and 2 studies for Etravirine that are also looking for participants."

Answered by AI

Are there any side effects to taking Etravirine?

"There is some efficacy data and multiple rounds of safety data available from Phase 3 trials, so our team has rated the safety of Etravirine as a 3."

Answered by AI

Can patients still join this experiment?

"According to data on clinicaltrials.gov, this study is not accepting patients at the moment. This particular trial was initially posted on December 9th 2009 and updated as recently as October 25th 2022. Even though this study isn't looking for participants right now, there are 505 other trials that are currently recruiting patients."

Answered by AI

What sort of precedents does this research have?

"Etravirine is being studied in 2 ongoing trials involving 180 patients from 2009. So far, 45 total trials have completed across 6 cities and 12 countries."

Answered by AI

Are there any similar drugs to Etravirine?

"Research into etravirine began in 2009 through the study registered under NCT00980538. As of now, there have been 45 completed studies with 2 ongoing ones; many of these taking place in Washington D.C"

Answered by AI

Could you provide the number of sites where this research is being conducted in America?

"This study is currently looking for participants from 5 recruitment sites, which are situated in Washington, Montreal and Philadelphia as well as other cities. If you're interested in enrolling, try to select the clinic that is most conveniently located to reduce travel time and costs."

Answered by AI
~12 spots leftby Mar 2025