NCT00905489

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, 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of the PK trial (visit 7) can enter into an Optional Extension Phase (OEP) until the Investigational New Drug (IND) is withdrawn; until nevirapine XR becomes approved and is available by prescription in a given country; or, the patient enrolls in a compassionate use program.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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P75+ for phase_1 hiv-infections

Timeline
Completed

Started Jun 2009

Typical duration for phase_1 hiv-infections

Geographic Reach
4 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2009

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 20, 2009

Completed
12 days until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

May 7, 2014

Completed
Last Updated

January 7, 2016

Status Verified

December 1, 2015

Enrollment Period

3.3 years

First QC Date

May 6, 2009

Results QC Date

September 23, 2013

Last Update Submit

December 2, 2015

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

  • Trough Cpre,N.

    Trough Nevirapine concentration immediately prior to the next scheduled dose. Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22. The measure of dispersion presented is the coefficient of variation (%) rather than the geometric coefficient of variation.

    Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR

Secondary Outcomes (14)

  • AUCt,ss

    Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR

  • Cmin,ss (for IR and XR Formulations by Nevirapine XR Dose Group)

    Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR

  • Cmax,ss (for IR and XR Formulations by Nevirapine XR Dose Group)

    Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR

  • Ratio Cmax,ss/Cmin,ss

    Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR

  • %PTF

    Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR

  • +9 more secondary outcomes

Other Outcomes (1)

  • Efficacy: Patients Maintaining a VL < 50 Copies/mL at Last Available Visit

    Last available visit, up to 155 weeks

Study Arms (1)

Nevirapine IR / Nevirapine XR

EXPERIMENTAL

In this pharmaco-kinetic (PK) cross-over design trial, all patients initially receive nevirapine immediate release and then all patients are switched to nevirapine extended release 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).

Drug: Nevirapine Immediate Release (IR)Drug: Nevirapine Extended Release (XR)

Interventions

Nevirapine Immediate Release (IR)DRUG

200 mg Tablet or 50 mg / 5 ml oral suspension

Also known as: Nevirapine IR
Nevirapine IR / Nevirapine XR
Nevirapine Extended Release (XR)DRUG

200 mg, 300 mg or 400 mg Tablet formulation

Also known as: Nevirapine XR
Nevirapine IR / Nevirapine XR

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

1100.1518.0001 Boehringer Ingelheim Investigational Site

Washington D.C., District of Columbia, United States

Location

1100.1518.0002 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

1100.1518.2605 Boehringer Ingelheim Investigational Site

Francistown, Botswana

Location

1100.1518.2601 Boehringer Ingelheim Investigational Site

Gaborone, Botswana

Location

1100.1518.2603 Boehringer Ingelheim Investigational Site

Gaborone, Botswana

Location

1100.1518.4902 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1100.1518.4901 Boehringer Ingelheim Investigational Site

Frankfurt am Main, Germany

Location

1100.1518.4903 Boehringer Ingelheim Investigational Site

München, Germany

Location

1100.1518.2702 Boehringer Ingelheim Investigational Site

Cape Town, South Africa

Location

1100.1518.2703 Boehringer Ingelheim Investigational Site

Parow Valley, South Africa

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Nevirapine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim Pharmaceuticals
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2009

First Posted

May 20, 2009

Study Start

June 1, 2009

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

January 7, 2016

Results First Posted

May 7, 2014

Record last verified: 2015-12

Locations

US(2)ZA(2)DE(3)BO(3)