A Phase I Multiple Dose Pharmacokinetic Study of Nevirapine Extended Release (XR) in HIV-1 Infected Children.
Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Nevirapine Immediate Release (IR) (Drug); Nevirapine Extended Release (XR) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Boehringer Ingelheim Official(s) and/or principal investigator(s): Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim
Summary
The primary objective is to establish the pharmacokinetic (PK) profile at steady state of
nevirapine XR in HIV infected children from >=3 to <18 years of age. This phase I trial is
an open-label, multiple dose, non-randomized and cross-over study. Patients who have
completed the last visit of the PK trial (visit 7) can enter into an Optional Extension
Phase (OEP) until the Investigational New Drug (IND) is withdrawn; until nevirapine XR
becomes approved and is available by prescription in a given country; or, the patient
enrolls in a compassionate use program. During this OEP, nevirapine XR safety and efficacy
information will be collected.
Clinical Details
Official title: An Open-label, Multiple Dose, Cross-over Study to Evaluate the Steady-state Pharmacokinetic Parameters of Nevirapine Extended Release Tablets in HIV-1 Infected Children, With an Optional Extension Phase
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Trough Cpre,N.
Secondary outcome: AUCt,ssCmin,ss (for IR and XR Formulations by Nevirapine XR Dose Group) Cmax,ss (for IR and XR Formulations by Nevirapine XR Dose Group) Ratio Cmax,ss/Cmin,ss %PTF Tmax,ss CL/F,ss Cavg Efficacy: Patients Maintaining a VL < 50 Copies/mL Efficacy: Patients Maintaining a VL < 400 Copies/mL Change From Baseline in Mean CD4+ Count (Absolute) Percentage Change From Baseline in Mean CD4+ Count
Eligibility
Minimum age: 3 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion criteria:
1. Signed and dated written informed consent of a parent or legal guardian prior to
admission. Active assent must be given by the patient if the child and/or adolescent
is capable of understanding the provided study information.
2. HIV-1 infected males or females >= 3 and < 18 years old.
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.
5. An HIV VL 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 VL 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 opinion of investigator.
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.
Exclusion criteria:
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 (Appendix
10. 2).
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
Locations and Contacts
1100.1518.2605 Boehringer Ingelheim Investigational Site, Francistown, Botswana
1100.1518.2601 Boehringer Ingelheim Investigational Site, Gaborone, Botswana
1100.1518.2603 Boehringer Ingelheim Investigational Site, Gaborone, Botswana
1100.1518.4902 Boehringer Ingelheim Investigational Site, Berlin, Germany
1100.1518.4901 Boehringer Ingelheim Investigational Site, Frankfurt/Main, Germany
1100.1518.4903 Boehringer Ingelheim Investigational Site, München, Germany
1100.1518.2702 Boehringer Ingelheim Investigational Site, Cape Town, South Africa
1100.1518.2703 Boehringer Ingelheim Investigational Site, Parow Valley, South Africa
1100.1518.0001 Boehringer Ingelheim Investigational Site, Washington, District of Columbia, United States
1100.1518.0002 Boehringer Ingelheim Investigational Site, Philadelphia, Pennsylvania, United States
Additional Information
Starting date: June 2009
Last updated: May 30, 2014
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