Clinical trial NCT00980538: TMC125-TiDP35-C239 - Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Participants
Official title: Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Subjects
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: HIV Infections
HIV-1
Keywords: TMC125-TiDP35-C239
TMC125-C239
TMC125
HIV
Etravirine
Intelence
IntelenceTM
Lead sponsor: Janssen Sciences Ireland UC
Sponsor class: INDUSTRY
First posted: 2009-09-21
Enrollment: 180
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants With At-least One Adverse Event as a Measure of Safety Until Etravirine (ETR)-Based Treatment Regimen is Commercially Available
timeFrame: Up to 10 years and 11 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: New York
country: United States
state: New York
city: Philadelphia
country: United States
state: Pennsylvania
city: Buenos Aires
country: Argentina
city: Ciudad Autonoma De Buenos Aire
country: Argentina
city: Belo Horizonte
country: Brazil
city: Ribeirao Preto
country: Brazil
city: Rio de Janeiro
country: Brazil
city: Montreal
country: Canada
state: Quebec
city: Lyon Cedex 08
country: France
city: Paris
country: France
city: Panama City
country: Panama
city: Rio Piedras
country: Puerto Rico
city: Bucuresti
country: Romania
city: Bloemfontein
country: South Africa
city: Boksburg
country: South Africa
city: Cape Town
country: South Africa
city: Dundee
country: South Africa
city: Durban N/a
country: South Africa
city: Durban
country: South Africa
city: George
country: South Africa
city: Johannesburg
country: South Africa
city: Newtown
country: South Africa
city: Pretoria N/a
country: South Africa
city: Pretoria
country: South Africa
city: Esplugues De Llobregat
country: Spain
city: Madrid
country: Spain
city: Sevilla
country: Spain
city: Bangkok
country: Thailand
city: Khon Kaen
country: Thailand
Study officials:
affiliation: Janssen Sciences Ireland UC
name: Janssen Sciences Ireland UC Clinical Trial
role: STUDY_DIRECTOR
References: