← Back to Search

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
Pivotal Trial
No Placebo-Only Group

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.
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.
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
56%
Blood cholesterol increased
51%
Low density lipoprotein increased
44%
Blood sodium decreased
32%
Blood bicarbonate decreased
31%
Blood glucose increased
29%
Blood phosphorus decreased
28%
Neutrophil count decreased
22%
Blood alkaline phosphatase increased
19%
Cough
18%
Aspartate aminotransferase increased
17%
Blood bilirubin increased
14%
Headache
14%
Blood glucose decreased
13%
Haemoglobin decreased
11%
Blood creatinine increased
11%
Rhinorrhoea
11%
Pyrexia
10%
Blood sodium increased
10%
Diarrhoea
10%
Upper respiratory tract infection
8%
Alanine aminotransferase increased
7%
Blood triglycerides increased
7%
White blood cell count decreased
7%
Abdominal pain
7%
Back pain
6%
Blood potassium decreased
6%
Chills
6%
Fatigue
6%
Gastroenteritis
6%
Blood potassium increased
6%
Decreased appetite
6%
Pain in extremity
6%
Dyspnoea
6%
Nasal congestion
4%
Rash
4%
Weight decreased
4%
Vomiting
4%
Abdominal pain upper
4%
Herpes zoster
4%
Arthralgia
4%
Pruritus
3%
Influenza
3%
Peptic ulcer
3%
Oral candidiasis
3%
Neuropathy peripheral
3%
Nasopharyngitis
3%
Vulvovaginal candidiasis
3%
Chest pain
3%
Acute sinusitis
3%
Vulvovaginal pruritus
3%
Oropharyngeal plaque
3%
Skin lesion
1%
Dysuria
1%
Urine odour abnormal
1%
Oesophageal carcinoma
1%
Hepatotoxicity
1%
Bacteraemia
1%
Meningitis bacterial
1%
Neurocryptococcosis
1%
Pregnancy
1%
Paraesthesia
1%
Purulent discharge
1%
Oropharyngeal pain
1%
Upper limb fracture
1%
Helminthic infection
1%
Platelet count decreased
1%
Myalgia
1%
Pulmonary tuberculosis
1%
Oedema peripheral
1%
Mastoiditis
1%
Hyperglycaemia
1%
Prostate cancer
1%
Idiopathic interstitial pneumonia
1%
Hypovolaemic shock
1%
Eye pain
1%
Acarodermatitis
1%
Blood pressure increased
1%
Vaginal discharge
1%
Blister
1%
Erythema
1%
Anaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Experimental: Sub-cohort B2
Experimental: Sub-cohort B3
Experimental: Cohort A
Experimental: Sub-cohort B1
Experimental: Cohort C
Experimental: Cohort D

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~11 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top