Open-label safety study of TMC114 in combination with low dose RTV and other ARVs in highly experienced HIV-1 infected patients with limited or no treatment options.

• Conditions: HIV-1 infected patient; MedDRA version: 7.1Level: 4Classification code 10020161

• Registration Number: EUCTR2005-000793-45-DE
• Lead Sponsor: Tibotec Pharmaceuticals Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-17
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Patient has voluntarily signed the informed consent before initiation of study procedures.
2. Patient with documented HIV-1 infection.
3. Male or female patient over 18 years of age.
4. Patient has limited or no treatment options because of multiple treatment failures.
5. Negative pregnancy test for females of childbearing potential.
6. CD4 cell count = 100 cells/mm3.
7. Viral load = 10000 copies/mL.

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

1. Primary HIV-infection.
2. Patient is eligible for other Tibotec-sponsored trials.
3. Prior or current participation to a trial with TMC114 (except for Phase I studies conducted in HIV-infected patients).
4. Use of disallowed concomitant therapy.
5. Use of investigational medication within the last 90 days. The following exceptions apply:
- abacavir/lamivudine and tenofovir/emtricitabine fixed dose combinations;
- tipranavir; TMC114 should not be used within 14 days following the use of tipranavir. A minimal 14-day washout period is required in which tipranavir must be either interrupted or substituted to an alternative investigator selected PI regimen until baseline visit (Day 1).
6. Pregnant or breast-feeding female.
7. Female patient of child bearing potential without the use of effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last trial related activity.
8. Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication (TMC114) or RTV.
9. Patients with the following laboratory abnormalities as defined by a standardized grading scheme based on the DAIDS table (updated version form December 2004):
- Any grade 3 or 4 toxicity with the following exceptions:
- Patients with pre-existing diabetes or asymptomatic glucose elevations of grade 3 or 4.
- Patients with asymptomatic triglyceride elevations of grade 3 or 4 or cholesterol elevations = grade 3.
10. Patient with clinical or laboratory evidence of active liver disease, liver impairment/dysfunction or cirrhosis irrespective of liver enzyme levels.

Study & Design

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