HIV-1 MedDRA version: 9.1 Level: LLT Classification code 10020161 Term: HIV infection
Conditions
Interventions
Trade Name: Prezista
Product Name: darunavir
Product Code: TMC114
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: darunavir
CAS Number: 206361-99-1
Current Sponsor code: Darunavir ethanol
Sponsors
Tibotec Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria are eligible for this trial. 1. Male or female adolescents, aged between 12 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects meeting one or more of the following criteria cannot be selected. 1. Subjects with presence of any currently active conditions included in the listing of WHOClinical Stage 4. 2. 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 trial protocol. 3. Previous or current use of ARVs (including both investigational as well as commercially available ARVs indicated for the treatment of HIV-infection and ARVs for treatment of hepatitis B infection with anti-HIV activity, e.g., adefovir, lamivudine, emtricitabine, entecavir). Note: Female adolescents who used a single dose of 200 mg of nevirapine to prevent MTCT are allowed in the trial, as long as they have never received other ARVs. Female adolescents who used zidovudine to prevent MTCT will not be allowed as this may result in reduced susceptibility to the ARV background regimen. Note: Subjects treated for postexposure prophylaxis will not be allowed. 4. Primary or acute HIV infection. 5. Use of any investigational agents within 30 days prior to screening. 6. Use of disallowed concomitant therapy. 7. Life expectancy less than 6 months, according to the judgment of the investigator. 8. Pregnant or breast-feeding. 9. Female subject of childbearing potential without use of effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period. Note: Estrogen hormonal based contraception may not be reliable when taking DRV/rtv, therefore to be eligible for this trial female subjects of childbearing potential should either: (1) use a double barrier method to prevent pregnancy (i.e., use a male condom with either diaphragm or cervical cap)*, or, (2) use non-estrogen hormonal based contraceptives in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap or female condom), or, (3) use an intra uterine device (IUD) in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap or female condom), or, (4) be non-heterosexually active, practice heterosexual abstinence or have a vasectomized partner (confirmed sterile). * a male and female condom should not be used together due to the risk of breakage or damage caused by latex friction. 10. Subjects with clinical or laboratory evidence of significantly decreased hepatic function or decompensation (i.e., liver insufficiency), irrespective of liver enzyme levels. Note: Subjects co-infected with chronic hepatitis B or C will be allowed to enter the trial if their condition is clinically stable and is not expected to require treatment during the trial period. Subjects diagnosed with acute viral hepatitis at screening will not be allowed in the trial. 11. Any active clinically significant disease (e.g., cardiac dysfunction, pancreatitis, acute viral infection) or findings during screening of medical history or physical examination that are expected to compromise the subject's safety or outcome in the trial. 12. Subjects with a grade 3 or 4 laboratory abnormality as defined by DAIDS grading table, with the following exceptions unless clinical assessment foresees an immediate health risk to the subject: - Subjects with pre-existing diabetes or with asymptomatic glucose grade 3 or 4 elevations. - Subjects with asymptomatic triglyceride or cholesterol elevations of grade 3 or 4. 13.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): primary efficacy parameter will be confirmed virologic response defined as percent of subjects with confirmed plasma viral load < 50 HIV-1 RNA copies/ml at week 24;Main Objective: The primary objectives of the trial are to evaluate the pharmacokinetics, safety, tolerability and efficacy of DRV/rtv 800/100 mg q.d. in combination with an investigator-selected background regimen (consisting of either AZT/3TC or ABC/3TC) over a 24-week treatment period in ARV treatment-naïve HIV-1 infected adolescents aged from 12 to < 18 years and weighing = 40 kg.;Secondary Objective: The secondary objectives are: - To evaluate long-term safety, tolerability and efficacy of DRV/rtv 800/100 mg q.d. (in combination with an investigator-selected background regimen) over a 48-week treatment period in this population. - To evaluate immunology, resistance characteristics, pharmacokinetics, and pharmacokinetic/pharmacodynamic (PK/PD) relationships over 48 weeks of treatment with DRV/rtv 800/100 mg q.d. (in combination with an investigator-selected background regimen) in this population. | — |
Countries
France, Ireland, Italy, Spain, United Kingdom
Outcome results
None listed