HIV-1, HIV Infections
Conditions
Keywords
TMC125-TiDP35-C239, TMC125-C239, TMC125, HIV, Etravirine, Intelence, IntelenceTM
Brief summary
The purpose of this study is to provide etravirine (ETR) through this trial until participants can be switched to locally available ETR-based treatment regimens (that is, commercially available and reimbursed, or accessible through another source \[example, access program or government program\]), or local standard of care, as appropriate.
Detailed description
This is open label continued access trial for HIV-1 infected children/adolescents who have completed treatment in clinical (parent) trial with etravirine (ETR) sponsored by/in collaboration with Janssen Research & Development and who continue to benefit from use of ETR. At baseline visit, eligibility criteria will be checked. If eligibility criteria are met, participants will either continue on ETR dose they received in previous ETR (parent) trial or on adjusted dose if required by investigator.ETR dose adjustment will be based on weight using dosing guidelines. Assessment visits are recommended every 3 months (pediatric) and 6 months (adults). For most of participant, their next visit will be final visit with data collection. New participants entering study, will have baseline visit without data collection. Thereafter visits and assessments will be performed per local standard of care and documented in the participant's medical records only. Investigators will continue to report SAEs possibly related to ETR and pregnancies to sponsor using regular reporting. Treatment will be continued until: investigator determines that participant no longer benefits from ETR treatment (e.g based on viral load); treatment limiting toxicity; loss to follow-up; consent withdrawal; pregnancy; program termination by Sponsor; ETR-based treatment regimen becomes commercially available for participant's use, and is reimbursed, or accessed by another source (e.g access/government program) in region participant is living, or participants switched to local standard of care, as appropriate. Adult participants will receive ETR 200mg BID.Pediatric participants will receive ETR, doses as received in previous ETR(parent) trial, with weight based dose adjustment if necessary. 10 to \<20kg:100mg BID (4\*25mg or 1 tablet 100mg) 20 to \<25kg:125mg BID (5\*25mg or 1 tablet 100mg+1 tablet 25mg) 25 to \<30kg:150mg BID (6\*25mg or 1 tablet 100mg+2 tablets 25mg) \>= 30kg:200mg BID (8\*25mg or 2\*100mg)
Interventions
DRUGEtravirine
Participants will be dosed with etravirine by weight up to a maximum dose of 200 mg bid until switched to an etravirine-based treatment regimens (i.e. commercially available and reimbursed, or accessible through another source) or local standard of care, as appropriate.
Sponsors
Janssen Sciences Ireland UC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants who meet all of the following criteria are eligible for this trial: Documented HIV-1 infection * Male or female participants, aged 2 years and older * Successfully completed a clinical (parent) pediatric trial with ETR sponsored by or in collaboration with Janssen Research \& Development, and continues to receive benefit from the use of ETR * Participant (where appropriate, depending on age) and their parent(s) or legal representative(s) have signed the Informed Consent Form (ICF)/Assent voluntarily * Children will be informed about the program and asked to give assent (where appropriate, depending on age) * Negative urine pregnancy test for females of childbearing potential
Exclusion criteria
* Participants meeting one or more of the following criteria cannot be selected: 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 * Any active clinically significant disease (e.g., pancreatitis, cardiac dysfunction) or findings of medical history, laboratory or physical examination that, in the investigator's opinion, would compromise the participant's safety during treatment with ETR * Previously demonstrated clinically significant allergy or hypersensitivity to ETR or to any of the excipients of ETR * Pregnant or breastfeeding * Non-vasectomized heterosexually active boys not using safe and effective birth control methods, or not willing to continue practicing these birth control methods, during the trial and until 30 days after the end of the trial (or after the last intake of the investigational medication) * Girls, who are sexually active and able to become pregnant, not using safe and effective birth control methods, or not willing to continue practicing these birth control methods, during the trial and until 30 days after the end of the trial (or after the last intake of the investigational medication)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With At-least One Adverse Event as a Measure of Safety Until Etravirine (ETR)-Based Treatment Regimen is Commercially Available | Up to 10 years and 11 months | 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. |
Countries
Argentina, Brazil, Canada, France, Panama, Puerto Rico, Romania, South Africa, Spain, Thailand, United States
Contacts
STUDY_DIRECTORJanssen Sciences Ireland UC Clinical Trial
Janssen Sciences Ireland UC
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 180 |
| Total | 180 |
Baseline characteristics
| Characteristic | Etravirine |
|---|---|
| Age, Categorical <=18 years | 71 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 106 Participants |
| AgeContinuous | 30.9 years STANDARD_DEVIATION 16.92 |
| Region of Enrollment ARGENTINA | 11 Participants |
| Region of Enrollment BRAZIL | 8 Participants |
| Region of Enrollment CANADA | 1 Participants |
| Region of Enrollment FRANCE | 3 Participants |
| Region of Enrollment ITALY | 6 Participants |
| Region of Enrollment PANAMA | 4 Participants |
| Region of Enrollment ROMANIA | 1 Participants |
| Region of Enrollment SOUTH AFRICA | 122 Participants |
| Region of Enrollment SPAIN | 7 Participants |
| Region of Enrollment THAILAND | 12 Participants |
| Region of Enrollment UNITED STATES | 5 Participants |
| Sex: Female, Male Female | 112 Participants |
| Sex: Female, Male Male | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 180 |
| other Total, other adverse events | 32 / 180 |
| serious Total, serious adverse events | 18 / 180 |
Outcome results
Primary
Number of Participants With At-least One Adverse Event as a Measure of Safety Until Etravirine (ETR)-Based Treatment Regimen is Commercially Available
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.
Time frame: Up to 10 years and 11 months
Population: Safety analysis set included all participants who received at least one dose of etravirine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Etravirine | 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 |