HIV-1 infected patient MedDRA version: 9.1 Level: LLT Classification code 10020161 Term: HIV infection
Conditions
Interventions
Trade Name: Prezista
Product Code: TMC114
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: darunavir
CAS Number: 206361-99-1
Current Sponsor code: TMC114
Other descriptive name: R319064
Co
Sponsors
Tibotec Pharmaceuticals Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject has voluntarily signed the informed consent before initiation of study procedures. 2. Subject with documented HIV-1 infection. 3. Male or female subject 18 years of age or older. 4. Subject has limited or no treatment options due to virological failure or intolerance to multiple ARV regimens. 5. Subject is at least 3 class experienced and has previously received 2 different PI based regimens. 6. Subject is not achieving adequate virologic suppression on his/her current regimen and at risk of clinical or immunologic progression*. (* May not be applicable if the subject is a roll over subject from TMC114-C202, TMC114-C209, TMC114-C213, TMC114-C215 or any other sponsor selected TMC114 trial without treatment interruption.) 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-1 infection. 2. Subject is eligible for other Tibotec sponsored HIV-1 trials. 3. Prior or current participation in a trial with TMC114 (This criterion does not apply to the following trials: - TMC114-C209 - TMC114-C202, TMC114-C213 and TMC114-C215 either if the subject has completed the 144 weeks treatment period or experiences a virologic failure as defined in the originating protocol and requires treatment with TMC114 in combination with an ARV that is not allowed per the originating protocol. - Other trials with TMC114 after prior discussion with and approval from the sponsor.) 4. Any condition (including but not limited to alcohol and drug use), which, in the opinion of the investigator, could compromise the subject’s safety or adherence to the study protocol. 5. Use of disallowed concomitant therapy (see Section 5.3.8). 6. Use of investigational medication within the last 30 days or during the trial. Exceptions: - use of investigational fixed dose combinations abacavir/lamuvidine and tenofovir/emtricitabine (if applicable, based on the status of local approval); - use of tipranavir (if applicable, based on the status of local approval). Tipranavir is allowed until the day before TMC114 intake (wash out period of 30 days is not applicable for tipranavir); - investigational ARVs for which favorable pharmacokinetic interaction and safety data support co-administration with TMC114 and low-dose RTV. Investigational drugs that fulfill this criterion will only be allowed after the sponsor has informed the investigators, applicable Ethics Committees and Health Authorities. 7. Any active clinically significant disease (e.g., cardiac dysfunction, pancreatitis, acute viral infection) or findings during screening of medical history or physical examination that is not either resolved or stabilized for at least 30 days before the screening phase of the trial. 8. Pregnant or breast-feeding female. 9. Female subject of childbearing potential not using effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last trial related activity. 10. Subjects with the following laboratory abnormalities as defined by a standardized grading scheme based on the DAIDS table (updated version from December 2004, see Section 7.2). Any grade 3 or 4 toxicity of the selected laboratory parameters as described in the section Subjects and Disease Characteristics (see Section 5.4.3). 11. Subject with clinical or laboratory evidence of active liver disease, liver impairment / dysfunction or cirrhosis irrespective of liver enzyme levels. 12. Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication (TMC114) or RTV.
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 subjects who have failed multiple ARV regimens.;Secondary Objective: The secondary objective is to gather information on the safety and tolerability of TMC114 in combination with low-dose RTV and other ARVs.;Primary end point(s): 1. Type and incidence of AEs and SAEs as captured by the protocol, and AEs leading to treatment discontinuation or treatment interruption between baseline and trial termination will be tabulated. Separate tabulations will be made by the severity of the AEs, drug relatedness and outcome. The number and causes of death will be summarized and the number of subjects who terminate treatment will be tabulated as well as the reasons for drug discontinuation. 2. The number and percentage of responders will be tabulated according to each of the following four definitions: plasma viral load <50 copies/mL, <400 copies/mL and a decrease 0.5 log10 or 1.0 log10 or more in plasma viral load. This will allow to evaluate the number of responders as well as non-responders. | — |
Countries
Italy, Lithuania
Outcome results
None listed