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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | 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of the PK trial (visit 7) can enter into an Optional Extension Phase (OEP) until the Investigational New Drug (IND) is withdrawn; until nevirapine XR becomes approved and is available by prescription in a given country; or, the patient enrolls in a compassionate use program.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 Drug: Nevirapine Immediate Release |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Crossover Assignment, Pharmacokinetics Study |
| 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: | December 2010 (Final data collection date for primary outcome measure) |
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, New Jersey | |
| 1100.1518.0004 Boehringer Ingelheim Investigational Site | |
| New Brunswick, New Jersey, United States | |
| United States, Pennsylvania | |
| 1100.1518.0002 Boehringer Ingelheim Investigational Site | |
| Philadelphia, Pennsylvania, United States | |
| Argentina | |
| 1100.1518.5401 Boehringer Ingelheim Investigational Site | |
| Capital Federal, Argentina | |
| Botswana | |
| 1100.1518.2601 Boehringer Ingelheim Investigational Site | |
| Gaborone, Botswana | |
| 1100.1518.2603 Boehringer Ingelheim Investigational Site | |
| Gaborone, Botswana | |
| 1100.1518.2605 Boehringer Ingelheim Investigational Site | |
| Francistown, Botswana | |
| Germany | |
| 1100.1518.4901 Boehringer Ingelheim Investigational Site | |
| Frankfurt/Main, Germany | |
| 1100.1518.4902 Boehringer Ingelheim Investigational Site | |
| Berlin, 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 ( Boehringer Ingelheim, Study Chair ) |
| Study ID Numbers: | 1100.1518, EudraCT No.: 2008-005855-61 |
| Study First Received: | May 6, 2009 |
| Last Updated: | January 13, 2010 |
| ClinicalTrials.gov Identifier: | NCT00905489 History of Changes |
| Health Authority: | Argentina: A.N.M.A.T. (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica); 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 |
|
Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Infection Antiviral Agents Pharmacologic Actions |
Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Virus Diseases Nevirapine Anti-Retroviral Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections Nucleic Acid Synthesis Inhibitors |