A phase I multiple dose pharmacokinetic study of nevirapine extended release (XR) in HIV-1 infected children.
- Conditions
- HIV-1 infected children under antiretroviral therapyMedDRA version: 14.0Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2008-005855-61-Outside-EU/EEA
- Lead Sponsor
- Boehringer Ingelheim (Pty) Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 75
1. Signed and dated written informed consent of a parent or legal guardian prior to
admission to the study in accordance with GCP and the local laws and regulations.
Active assent must be given by the patient if the child and/or adolescent is capable of
understanding the provided study information [based on the local laws and regulations
of each country and site].
2. HIV-1 infected males or females = 3 and < 18 years old.
Final,
BI Trial No.: Trial Protocol Page
Boehringer Ingelheim 4 Dec 2008
1100.1518 28
3. BSA = 0.58 m2 for patients using BSA to calculate nevirapine IR dose; or BW
= 12.5 kg for patients using BW to calculate nevirapine IR dose, at screening visit.
4. Treated with a nevirapine IR based regimen for at least 18 weeks prior to screening
visit (Visit 1); no modifications in the ARV background therapy within the last
2 weeks prior to screening, and the expectancy to stay under the same antiviral
regimen for at least 30 weeks.
5. An HIV viral load of <50 copies/mL while receiving nevirapine IR at the last measure
of VL documented in the medical record obtained within a period of 5 months prior to
screening visit.
6. An HIV viral load of <50 copies/mL at screening visit.
7. A stable or not decreasing CD4+ cell count according to the investigator’s opinion.
8. Acceptable screening laboratory values that indicate adequate baseline organ function
according to the investigator’s opinion.
9. ALT and AST = 2.5 X ULN (DAIDS Grade 1).
10. Serum creatinine levels = 1.3 X ULN (DAIDS Grade 1).
11. Patients able to swallow tablets.
Are the trial subjects under 18? yes
Number of subjects for this age range: 75
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
1. Any AIDS-related or AIDS defining illness that is unresolved or not stable on
treatment at least 8 weeks prior to screening visit.
2. Diseases other than HIV infection or conditions that, in the investigator's opinion,
would interfere with the study.
3. Patients who have been diagnosed with malignant disease and who are receiving
systemic chemotherapy or are anticipated to receive any therapy during their
participation in this trial.
4. Use of investigational medications or vaccines within 28 days prior to Visit 1 or
during the trial.
5. Use of immunomodulatory drugs within 28 days before Visit 1 or during the trial
(e.g., interferon, cyclosporin, hydroxyurea, interleukin 2).
6. Concomitant protease inhibitor (PI) treatment.
7. Unwillingness to abstain from ingesting substances during the study which may alter
plasma drug concentrations by interaction with the cytochrome P450 system
8. Female patients of childbearing potential who:
• have a positive serum pregnancy test at screening,
• are breast feeding,
• are planning on becoming pregnant,
• are not willing to use double-barrier methods (simultaneous use of two different
methods such as diaphragm with spermicidal substance and condom) of
contraception, or require ethinyl estradiol administration. Barrier methods of
contraception include diaphragm with spermicidal substance, cervical caps and
condoms.
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