HIV-1 infected patient MedDRA version: 7.1 Level: 4 Classification code 10020161
Conditions
Interventions
Product Code: TMC114
Pharmaceutical Form: Tablet
INN or Proposed INN: darunavir
CAS Number: 206361-99-1
Current Sponsor code: TMC114
Other descriptive name: R319064
Concentration unit: mg milligram(s)
Sponsors
Tibotec Pharmaceuticals Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to provide early access to TMC114 for highly ARV-experienced HIV-1 infected patients who have failed and exhausted treatment options based on commercially available ARVs. ;Secondary Objective: The secondary objective is to gather additional information on the safety and tolerability of TMC114 in combination with low dose RTV and other ARVs. ;Primary end point(s): An intent-to-treat analysis will be performed, i.e., all patients, regardless of their compliance with the protocol, are to be included in the analysis (unless no trial medication has been taken at all). The safety and tolerability of TMC114 in combination with low dose RTV and other ARVs will be evaluated over time. Where possible, virologic and immunologic response will also be evaluated. * Type and incidence of AEs between baseline and trial termination will be evaluated * The ECG parameters should be described (heart rate and rhythm, PR interval, QRS interval, RR interval, if available, and QT interval). * Vital signs include body temperature, heart rate, systolic blood pressure and diastolic blood pressure and will be evaluated. * For the test results, laboratory abnormalities will be calculated according to the standardized DAIDS severity grading table. | — |
Countries
Germany, Italy
Outcome results
None listed