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HIV patients get continued access to key drug in safety study

NCT ID NCT00980538

Disease control Sponsor: Janssen Sciences Ireland UC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study gave HIV-1 patients continued access to the drug etravirine until they could switch to a local treatment. It included 180 people aged 2 and older who had already benefited from the drug in a previous trial. The main goal was to monitor safety while providing the medication.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

180 people

The number who actually took part.

Started

Dec 2009

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV infections HIV-1

Contacts and locations

Locations

  • Study site

    Los Angeles, California, United States

  • Study site

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

  • Study site

    New York, New York, United States

  • Study site

    Philadelphia, Pennsylvania, United States

  • Study site

    Buenos Aires, Argentina

  • Study site

    Ciudad Autonoma de Buenos Aire, Argentina

  • Study site

    Belo Horizonte, Brazil

  • Study site

    Ribeirão Preto, Brazil

  • Study site

    Rio de Janeiro, Brazil

  • Study site

    Montreal, Quebec, Canada

  • Study site

    Lyon, France

  • Study site

    Paris, France

  • Study site

    Panama City, Panama

  • Study site

    Rio Piedras, Puerto Rico

  • Study site

    Bucharest, Romania

  • Study site

    Bloemfontein, South Africa

  • Study site

    Boksburg, South Africa

  • Study site

    Cape Town, South Africa

  • Study site

    Dundee, South Africa

  • Study site

    Durban, South Africa

  • Study site

    George, South Africa

  • Study site

    Johannesburg, South Africa

  • Study site

    Newtown, South Africa

  • Study site

    Pretoria, South Africa

  • Study site

    Esplugues de Llobregat, Spain

  • Study site

    Madrid, Spain

  • Study site

    Seville, Spain

  • Study site

    Bangkok, Thailand

  • Study site

    Khon Kaen, Thailand

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