A Phase II, open-label trial, to evaluate pharmacokinetics, safety, tolerability and antiviral activity of DRV/rtv once daily in treatment-naïve HIV 1 infected adolescents aged between 12 and < 18 years. - DIONE
- Conditions
- HIV-1MedDRA version: 9.1Level: LLTClassification code 10020161Term: HIV infection
- Registration Number
- EUCTR2008-004631-37-IE
- Lead Sponsor
- Tibotec Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12
Subjects who meet all of the following criteria are eligible for this trial.
1. Male or female adolescents, aged between 12 and < 18 years at screening.
2. Subjects with a documented HIV-1 infection.
3. Body weight from at least 40 kg at screening.
4. Screening plasma HIV-1 RNA = 1000 copies/mL.
5. Subjects qualify for treatment initiation based on the investigator's assessments and/or according to treatment guidelines.
Note: Current treatment guidelines recommend considering initiation of ART when CD4+ cell counts are below 350 cells/µL. However, clinical situations may warrant initiating ART with CD4+ cell counts above 350 cells/µL. Examples of such situations would include rapidly declining CD4+ cell counts over time, high plasma viral load, history of AIDS-defining illnesses or severe symptoms of HIV infection.
6. Parents or legal representative and trial subjects (where appropriate, depending on age and local regulation) willing and able to give consent and assent.
7. Subjects can comply with the protocol requirements.
8. General medical condition, in the investigator’s opinion, does not interfere with the assessments and the completion of the trial.
9. Able to swallow DRV tablets (400 mg) and ritonavir capsules (100 mg).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method