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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by (Responsible Party): | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00905489 |
Purpose
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of the PK trial (visit 7) can enter into an Optional Extension Phase (OEP) until the Investigational New Drug (IND) is withdrawn; until nevirapine XR becomes approved and is available by prescription in a given country; or, the patient enrolls in a compassionate use program.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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Nevirapine extended release |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multiple Dose PK Study of Nevirapine XR in HIV-1 Infected Children |
| Estimated Enrollment: | 75 |
| Study Start Date: | June 2009 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Nevirapine Immediate Release
Patients receive nevirapine immediate release either suspension or 200 mg tablets BID according to the VIRAMUNE approved label.
|
Drug: Nevirapine extended release
100 mg or 400 mg Tablet formulation
|
|
Experimental: Nevirapine Extended Release
Since this is a PK cross-over design trial, patients receiving nevirapine immediate release are switched to nevirapine extended release 200 mg, 300 mg or 400 mg QD.
|
Drug: Nevirapine extended release
100 mg or 400 mg Tablet formulation
|
Eligibility| Ages Eligible for Study: | 3 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Female patients of childbearing potential who:
Contacts and Locations| United States, District of Columbia | |
| 1100.1518.0001 Boehringer Ingelheim Investigational Site | |
| Washington, District of Columbia, United States | |
| United States, Pennsylvania | |
| 1100.1518.0002 Boehringer Ingelheim Investigational Site | |
| Philadelphia, Pennsylvania, United States | |
| Botswana | |
| 1100.1518.2605 Boehringer Ingelheim Investigational Site | |
| Francistown, Botswana | |
| 1100.1518.2603 Boehringer Ingelheim Investigational Site | |
| Gaborone, Botswana | |
| 1100.1518.2601 Boehringer Ingelheim Investigational Site | |
| Gaborone, Botswana | |
| Germany | |
| 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 | |
| South Africa | |
| 1100.1518.2702 Boehringer Ingelheim Investigational Site | |
| Cape Town, South Africa | |
| 1100.1518.2703 Boehringer Ingelheim Investigational Site | |
| Parow Valley, South Africa | |
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00905489 History of Changes |
| Other Study ID Numbers: | 1100.1518, 2008-005855-61 |
| Study First Received: | May 6, 2009 |
| Last Updated: | February 8, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; Republic of Botswana: Ministry of Health; South Africa: MCC (Medicines Control Council); United States: Food and Drug Administration |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Nevirapine Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |