A Phase I Multiple Dose Pharmacokinetic Study of Nevirapine Extended Release (XR) in HIV-1 Infected Children. - NCT00905489- (Clinical Trial 293603)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy293603.aspx
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Philadelphia |
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State:
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PA |
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| Conditions: |
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HIV Infections |
| Purpose: |
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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Phase (OEP) until the Investigational New Drug (IND) is withdrawn; until nevirapine XR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.
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| Study summary: |
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| Criteria: |
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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 |
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| Study is available at: |
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1100.1518.0002 Boehringer Ingelheim Investigational Site
Philadelphia, PA
United States
Primary Contact:
Boehringer Ingelheim Study Coordinator
Email: clintriage.rdg@boehringer-ingelheim.com
Phone: 1-800-243-0127 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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