Trial Outcomes & Findings for TMC125-TiDP35-C239 - Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Participants (NCT NCT00980538)
NCT ID: NCT00980538
Last Updated: 2025-12-23
Results Overview
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
180 participants
Primary outcome timeframe
Up to 10 years and 11 months
Results posted on
2025-12-23
Participant Flow
Participant milestones
| Measure |
Etravirine
Participants who previously received etravirine (ETR) in clinical trial with ETR (NCT00254046, NCT00255099, NCT00359021, NCT00665847, NCT01504841) sponsored by/in collaboration with Janssen Research \& Development and continued to benefit from its use, in countries where ETR was not commercially available, was not reimbursed, and could not be accessed through another source, or where the participant was not eligible for ongoing trials with ETR received ETR 200 milligrams (mg) twice daily (bid) in adults. Pediatric participants received ETR doses as received in previous ETR (parent) trial, with weight based dose adjustment if necessary (ETR 100 mg bid for weight 10 to less than \[\<\] 20 kilograms \[kg\]; ETR 125 mg bid for weight 20 to \<25 kg; ETR 150 mg bid for weight 25 to \<30 kg; and 200 mg bid for weight greater than or equal to \[\>=\] 30 kg). Treatment continued until one of the following criteria was met: participant no longer benefited from etravirine treatment, toxicity, loss to follow up, etravirine became commercially available for participants' use.
|
|---|---|
|
Overall Study
STARTED
|
180
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
180
|
Reasons for withdrawal
| Measure |
Etravirine
Participants who previously received etravirine (ETR) in clinical trial with ETR (NCT00254046, NCT00255099, NCT00359021, NCT00665847, NCT01504841) sponsored by/in collaboration with Janssen Research \& Development and continued to benefit from its use, in countries where ETR was not commercially available, was not reimbursed, and could not be accessed through another source, or where the participant was not eligible for ongoing trials with ETR received ETR 200 milligrams (mg) twice daily (bid) in adults. Pediatric participants received ETR doses as received in previous ETR (parent) trial, with weight based dose adjustment if necessary (ETR 100 mg bid for weight 10 to less than \[\<\] 20 kilograms \[kg\]; ETR 125 mg bid for weight 20 to \<25 kg; ETR 150 mg bid for weight 25 to \<30 kg; and 200 mg bid for weight greater than or equal to \[\>=\] 30 kg). Treatment continued until one of the following criteria was met: participant no longer benefited from etravirine treatment, toxicity, loss to follow up, etravirine became commercially available for participants' use.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
20
|
|
Overall Study
Sponsor's Decision
|
4
|
|
Overall Study
Participant/Legal Representative Withdrew Consent/Assent
|
34
|
|
Overall Study
Adverse Event/HIV-Related Event/Cutaneous Event/Rash
|
12
|
|
Overall Study
Switch to Commercially Available Medication
|
25
|
|
Overall Study
Participant Non-Compliant
|
9
|
|
Overall Study
Investigator no Longer Thinks Participant Benefits from the ETR Treatment
|
9
|
|
Overall Study
Participant Ineligible to Continue the Trial
|
6
|
|
Overall Study
Other
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Etravirine
n=180 Participants
Participants who previously received etravirine (ETR) in clinical trial with ETR (NCT00254046, NCT00255099, NCT00359021, NCT00665847, NCT01504841) sponsored by/in collaboration with Janssen Research \& Development and continued to benefit from its use, in countries where ETR was not commercially available, was not reimbursed, and could not be accessed through another source, or where the participant was not eligible for ongoing trials with ETR received ETR 200 milligrams (mg) twice daily (bid) in adults. Pediatric participants received ETR doses as received in previous ETR (parent) trial, with weight based dose adjustment if necessary (ETR 100 mg bid for weight 10 to less than \[\<\] 20 kilograms \[kg\]; ETR 125 mg bid for weight 20 to \<25 kg; ETR 150 mg bid for weight 25 to \<30 kg; and 200 mg bid for weight greater than or equal to \[\>=\] 30 kg). Treatment continued until one of the following criteria was met: participant no longer benefited from etravirine treatment, toxicity, loss to follow up, etravirine became commercially available for participants' use.
|
|---|---|
|
Age, Categorical
<=18 years
|
71 Participants
n=180 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
106 Participants
n=180 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=180 Participants
|
|
Age, Continuous
|
30.9 years
STANDARD_DEVIATION 16.92 • n=180 Participants
|
|
Sex: Female, Male
Female
|
112 Participants
n=180 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=180 Participants
|
|
Region of Enrollment
ARGENTINA
|
11 Participants
n=180 Participants
|
|
Region of Enrollment
BRAZIL
|
8 Participants
n=180 Participants
|
|
Region of Enrollment
CANADA
|
1 Participants
n=180 Participants
|
|
Region of Enrollment
FRANCE
|
3 Participants
n=180 Participants
|
|
Region of Enrollment
ITALY
|
6 Participants
n=180 Participants
|
|
Region of Enrollment
PANAMA
|
4 Participants
n=180 Participants
|
|
Region of Enrollment
ROMANIA
|
1 Participants
n=180 Participants
|
|
Region of Enrollment
SOUTH AFRICA
|
122 Participants
n=180 Participants
|
|
Region of Enrollment
SPAIN
|
7 Participants
n=180 Participants
|
|
Region of Enrollment
THAILAND
|
12 Participants
n=180 Participants
|
|
Region of Enrollment
UNITED STATES
|
5 Participants
n=180 Participants
|
PRIMARY outcome
Timeframe: Up to 10 years and 11 monthsPopulation: Safety analysis set included all participants who received at least one dose of etravirine.
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Outcome measures
| Measure |
Etravirine
n=180 Participants
Participants who previously received etravirine (ETR) in clinical trial with ETR (NCT00254046, NCT00255099, NCT00359021, NCT00665847, NCT01504841) sponsored by/in collaboration with Janssen Research \& Development and continued to benefit from its use, in countries where ETR was not commercially available, was not reimbursed, and could not be accessed through another source, or where the participant was not eligible for ongoing trials with ETR received ETR 200 milligrams (mg) twice daily (bid) in adults. Pediatric participants received ETR doses as received in previous ETR (parent) trial, with weight based dose adjustment if necessary (ETR 100 mg bid for weight 10 to less than \[\<\] 20 kilograms \[kg\]; ETR 125 mg bid for weight 20 to \<25 kg; ETR 150 mg bid for weight 25 to \<30 kg; and 200 mg bid for weight greater than or equal to \[\>=\] 30 kg). Treatment continued until one of the following criteria was met: participant no longer benefited from etravirine treatment, toxicity, loss to follow up, etravirine became commercially available for participants' use.
|
|---|---|
|
Number of Participants With At-least One Adverse Event as a Measure of Safety Until Etravirine (ETR)-Based Treatment Regimen is Commercially Available
|
42 Participants
|
Adverse Events
Etravirine
Serious events: 18 serious events
Other events: 32 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Etravirine
n=180 participants at risk
Participants who previously received etravirine (ETR) in clinical trial with ETR (NCT00254046, NCT00255099, NCT00359021, NCT00665847, NCT01504841) sponsored by/in collaboration with Janssen Research \& Development and continued to benefit from its use, in countries where ETR was not commercially available, was not reimbursed, and could not be accessed through another source, or where the participant was not eligible for ongoing trials with ETR received ETR 200 milligrams (mg) twice daily (bid) in adults. Pediatric participants received ETR doses as received in previous ETR (parent) trial, with weight based dose adjustment if necessary (ETR 100 mg bid for weight 10 to less than \[\<\] 20 kilograms \[kg\]; ETR 125 mg bid for weight 20 to \<25 kg; ETR 150 mg bid for weight 25 to \<30 kg; and 200 mg bid for weight greater than or equal to \[\>=\] 30 kg). Treatment continued until one of the following criteria was met: participant no longer benefited from etravirine treatment, toxicity, loss to follow up, etravirine became commercially available for participants' use.
|
|---|---|
|
Cardiac disorders
Myocardial Infarction
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
General disorders
Accidental Death
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
General disorders
Death
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Infections and infestations
Chronic Tonsillitis
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Infections and infestations
Disseminated Tuberculosis
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Infections and infestations
Gastroenteritis
|
1.1%
2/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Infections and infestations
Pneumonia
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Infections and infestations
Sepsis
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Injury, poisoning and procedural complications
Brain Herniation
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma Recurrent
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Central Nervous System
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Lymph Nodes
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Nervous system disorders
Encephalopathy
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Psychiatric disorders
Depression
|
1.1%
2/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Vascular disorders
Hypovolaemic Shock
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
Other adverse events
| Measure |
Etravirine
n=180 participants at risk
Participants who previously received etravirine (ETR) in clinical trial with ETR (NCT00254046, NCT00255099, NCT00359021, NCT00665847, NCT01504841) sponsored by/in collaboration with Janssen Research \& Development and continued to benefit from its use, in countries where ETR was not commercially available, was not reimbursed, and could not be accessed through another source, or where the participant was not eligible for ongoing trials with ETR received ETR 200 milligrams (mg) twice daily (bid) in adults. Pediatric participants received ETR doses as received in previous ETR (parent) trial, with weight based dose adjustment if necessary (ETR 100 mg bid for weight 10 to less than \[\<\] 20 kilograms \[kg\]; ETR 125 mg bid for weight 20 to \<25 kg; ETR 150 mg bid for weight 25 to \<30 kg; and 200 mg bid for weight greater than or equal to \[\>=\] 30 kg). Treatment continued until one of the following criteria was met: participant no longer benefited from etravirine treatment, toxicity, loss to follow up, etravirine became commercially available for participants' use.
|
|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Eye disorders
Conjunctival Haemorrhage
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Gastrointestinal disorders
Aphthous Ulcer
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
3/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Gastrointestinal disorders
Odynophagia
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Gastrointestinal disorders
Vomiting
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
General disorders
Pyrexia
|
1.1%
2/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Infections and infestations
Conjunctivitis
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Infections and infestations
Gastroenteritis
|
1.1%
2/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Infections and infestations
Herpes Simplex
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Infections and infestations
Influenza
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Infections and infestations
Lice Infestation
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Infections and infestations
Nasopharyngitis
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Infections and infestations
Oral Herpes
|
1.1%
2/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Infections and infestations
Otitis Media
|
1.1%
2/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Infections and infestations
Tonsillitis
|
2.2%
4/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Infections and infestations
Tracheobronchitis
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.8%
5/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Infections and infestations
Vulvovaginal Candidiasis
|
1.1%
2/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Investigations
Hepatic Enzyme Increased
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Investigations
Lipase Increased
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Papilloma
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Nervous system disorders
Headache
|
1.1%
2/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Nervous system disorders
Syncope
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
2.2%
4/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Psychiatric disorders
Anxiety
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Renal and urinary disorders
Nephropathy
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.8%
5/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Skin and subcutaneous tissue disorders
Lipoatrophy
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Skin and subcutaneous tissue disorders
Lipohypertrophy
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.2%
4/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
|
Skin and subcutaneous tissue disorders
Skin Hypopigmentation
|
0.56%
1/180 • Up to 10 years and 11 months
Safety analysis set included all participants who received at least one dose of etravirine.
|
Additional Information
DIRECTOR CLINICAL LEADER EST PRODUCTS
Janssen Research & Development, LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees that before he/she publishes any results of this trial, he/she shall allow at least 45 days for the Sponsor to review the pre-publication manuscript prior to submission of the manuscript to the publisher, as specified in the Clinical Trial Agreement between Institution/Investigator and Sponsor.
- Publication restrictions are in place
Restriction type: OTHER