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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years and 11 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years and 11 months
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 • NCT0164136760%
Blood sodium decreased
46%
Low density lipoprotein increased
44%
Blood cholesterol increased
39%
Blood bicarbonate decreased
37%
Blood alkaline phosphatase increased
31%
Blood bilirubin increased
30%
Blood glucose increased
29%
Blood phosphorus decreased
26%
Aspartate aminotransferase increased
21%
Neutrophil count decreased
16%
Alanine aminotransferase increased
13%
Blood creatinine increased
13%
Cough
11%
Platelet count decreased
11%
Pyrexia
10%
Blood glucose decreased
10%
White blood cell count decreased
9%
Upper respiratory tract infection
9%
Haemoglobin decreased
7%
Blood potassium increased
7%
Rhinorrhoea
6%
Blood potassium decreased
6%
Blood sodium increased
6%
Herpes zoster
4%
Pruritus
4%
Vomiting
4%
Blood triglycerides increased
4%
Headache
3%
Pregnancy
3%
Oral candidiasis
3%
Oropharyngeal plaque
3%
Neuropathy peripheral
3%
Abdominal pain
3%
Pneumonia bacterial
3%
Urinary tract infection
3%
Decreased appetite
3%
Oropharyngeal pain
3%
Blister
1%
Skin lesion
1%
Bacteraemia
1%
Urine odour abnormal
1%
Hepatitis acute
1%
Hypertension
1%
Abortion threatened
1%
Abortion
1%
Paraesthesia
1%
Pain in extremity
1%
Scrub typhus
1%
Dysuria
1%
Death
1%
Back pain
1%
Renal failure
1%
Abdominal pain upper
1%
Fatigue
1%
Acarodermatitis
1%
Blood alkaline phosphatase abnormal
1%
Blood pressure increased
1%
Weight decreased
1%
Arthralgia
1%
Myalgia
1%
Vaginal discharge
1%
Dyspnoea
1%
Nasal congestion
1%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Experimental: Cohort C
Experimental: Cohort D
Experimental: Sub-cohort B2
Experimental: Sub-cohort B3
Experimental: Sub-cohort B1
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I completed a pediatric trial with ETR and it's still benefiting me.My child understands the study and agrees to participate.I do not have any serious health conditions that could make treatment unsafe for me.I am at least 2 years old.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.I am using or willing to use effective birth control during and 30 days after the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Etravirine
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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