NCT00980538

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P25-P50 for phase_3 hiv-infections

Timeline
Completed

Started Dec 2009

Longer than P75 for phase_3 hiv-infections

Geographic Reach
11 countries

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

December 9, 2009

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 21, 2021

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2026

Completed
Last Updated

June 9, 2026

Status Verified

May 1, 2026

Enrollment Period

11 years

First QC Date

September 18, 2009

Results QC Date

November 24, 2021

Last Update Submit

May 14, 2026

Conditions

HIV InfectionsHIV-1

Keywords

TMC125-TiDP35-C239TMC125-C239TMC125HIVEtravirineIntelenceIntelenceTM

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 10 years and 11 months

Study Arms (1)

Etravirine

EXPERIMENTAL

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.

Drug: Etravirine

Interventions

EtravirineDRUG

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.

Etravirine

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Washington D.C., District of Columbia, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Buenos Aires, Argentina

Location

Unknown Facility

Ciudad Autonoma de Buenos Aire, Argentina

Location

Unknown Facility

Belo Horizonte, Brazil

Location

Unknown Facility

Ribeirão Preto, Brazil

Location

Unknown Facility

Rio de Janeiro, Brazil

Location

Unknown Facility

Montreal, Quebec, Canada

Location

Unknown Facility

Lyon, France

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Panama City, Panama

Location

Unknown Facility

Rio Piedras, Puerto Rico

Location

Unknown Facility

Bucharest, Romania

Location

Unknown Facility

Bloemfontein, South Africa

Location

Unknown Facility

Boksburg, South Africa

Location

Unknown Facility

Cape Town, South Africa

Location

Unknown Facility

Dundee, South Africa

Location

Unknown Facility

Durban, South Africa

Location

Unknown Facility

George, South Africa

Location

Unknown Facility

Johannesburg, South Africa

Location

Unknown Facility

Newtown, South Africa

Location

Unknown Facility

Pretoria, South Africa

Location

Unknown Facility

Esplugues de Llobregat, Spain

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

Seville, Spain

Location

Unknown Facility

Bangkok, Thailand

Location

Unknown Facility

Khon Kaen, Thailand

Location

MeSH Terms

Conditions

HIV Infections

Interventions

etravirine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
DIRECTOR CLINICAL LEADER EST PRODUCTS
Organization
Janssen Research & Development, LLC
ClinicalTrialDisclosure@its.jnj.com
844-434-4210

Study Officials

  • Janssen Sciences Ireland UC Clinical Trial

    Janssen Sciences Ireland UC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2009

First Posted

September 21, 2009

Study Start

December 9, 2009

Primary Completion

November 25, 2020

Study Completion

April 8, 2026

Last Updated

June 9, 2026

Results First Posted

December 21, 2021

Record last verified: 2026-05

Locations

US(4)AR(2)TH(2)ES(3)RO(1)BR(3)PA(1)PR(1)CA(1)FR(2)ZA(9)