Status:
COMPLETED
A Phase I Multiple Dose Pharmacokinetic Study of Nevirapine Extended Release (XR) in HIV-1 Infected Children.
Lead Sponsor:
Boehringer Ingelheim
Conditions:
HIV Infections
Eligibility:
All Genders
3-17 years
Phase:
PHASE1
Brief 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, mu...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.
- HIV-1 infected males or females \>= 3 and \< 18 years old.
- 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.
- 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.
- 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.
- An HIV VL of \<50 copies/mL at screening visit.
- A stable or not decreasing CD4+ cell count according to the investigator's opinion.
- Acceptable screening laboratory values that indicate adequate baseline organ function according to the opinion of investigator.
- ALT and AST \<= 2.5 X ULN (DAIDS Grade 1).
- Serum creatinine levels \<= 1.3 X ULN (DAIDS Grade 1).
- Patients able to swallow tablets.
- Exclusion criteria:
- Any AIDS-related or AIDS defining illness that is unresolved or not stable on treatment at least 8 weeks prior to screening visit.
- Diseases other than HIV infection or conditions that, in the investigator's opinion, would interfere with the study.
- 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.
- Use of investigational medications or vaccines within 28 days prior to Visit 1 or during the trial.
- Use of immunomodulatory drugs within 28 days before Visit 1 or during the trial (e.g., interferon, cyclosporin, hydroxyurea, interleukin 2).
- Concomitant protease inhibitor (PI) treatment.
- 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).
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00905489
Start Date
June 1 2009
End Date
September 1 2012
Last Update
January 7 2016
Active Locations (10)
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1
1100.1518.0001 Boehringer Ingelheim Investigational Site
Washington D.C., District of Columbia, United States
2
1100.1518.0002 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
3
1100.1518.2605 Boehringer Ingelheim Investigational Site
Francistown, Botswana
4
1100.1518.2601 Boehringer Ingelheim Investigational Site
Gaborone, Botswana