An open label trial of TMC114/RTV in HIV-1 infected subjects who were randomized in the trials TMC114-C201, TMC114-C207 or in sponsor selected Phase I trials. - TMC114-C208

• Conditions: HIV-1 infection; MedDRA version: 9.1Level: LLTClassification code 10020161Term: HIV infection

• Registration Number: EUCTR2004-001246-33-AT
• Lead Sponsor: Tibotec Pharmaceuticals Limited Ireland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10-19
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

ORIGINAL PART OF THE TRIAL

1. Subject has signed the informed consent form voluntarily.
2. Male or female subjects aged at least 18 years.
3. Previous randomization to one of the treatment groups (including control) in the
TMC114-C201, TMC114-C207 trial or in sponsor selected Phase I trials.
4. Subject agrees to take at least 2 ARVs including approved NRTIs/NtRTIs, NNRTIs,
and/or T-20 in combination with the study medication (TMC114/RTV) from baseline
onwards.
5. Subject can comply with the protocol requirements.
6. Subject’s general medical condition is, in the investigator’s opinion, not interfering
with the assessments and the conduct of the trial.

EXTENSION PART OF THE TRIAL

1. Male or female subject, 18 years and above;
2. Subject completed 96 weeks of treatment with TMC114 in the original part of the
TMC114-C208 trial and TMC114 is not yet commercially available;
3. Subject has signed the informed consent form voluntary;
4. Subject can comply with the protocol requirements;
5. Subject’s general medical condition, in the investigator’s opinion, does not interfere with the assessments and the conduct of the trial.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

ORIGINAL PART OF THE TRIAL

1. Use of disallowed concomitant therapy.
2. Use of other investigational drugs (except for emtricitabine [FTC], fos-amprenavir,
tipranavir, T-20 and atazanavir where approval status may vary from country to country), within 30 days prior to the investigational medication
administration.
3. Current or past history of active alcohol and/or drug use which in the investigator’s
opinion would compromise the subject’s safety or compliance to the trial protocol
procedures.
4. Pregnant or breast-feeding females.
5. Female subjects of childbearing potential without the use of effective birth control
methods or not willing to continue practicing these birth control methods from
screening until at least 30 days after the end of the treatment period.
6. Any active or unstable medical condition (e.g., tuberculosis; cardiac dysfunction;
pancreatitis; acute viral infections) or findings during physical examination that, in the
investigator’s opinion, would compromise the subject’s safety.
7. Subject with the following laboratory abnormalities at screening.
8. Subject with clinical or laboratory evidence of active liver disease, liver
impairment/dysfunction or cirrhosis irrespective of liver enzyme levels.
9. Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication (TMC114/RTV)

EXTENSION PART OF THE TRIAL

1. Use of disallowed concomitant therapy;
2. Pregnant or breast-feeding female;
3. Female of childbearing potential without the use of effective birth control methods from screening until at least 30 days after the end of the treatment period;
4. Any active or unstable medical condition (e.g., TB, cardiac dysfunction, pancreatitis,
acute viral infections) or findings during physical examination that, in the investigator’s opinion, would compromise the subject’s safety.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the trial is to evaluate the long-term safety and tolerability of TMC114/RTV 600/100 mg b.i.d.;Secondary Objective: The secondary objectives are:<br>• To evaluate the antiviral activity over time;<br>• To evaluate the immunological effect over time.;Primary end point(s):