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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000634 |
To generate initial information on the pharmacokinetics (blood levels) and dose proportionality of nevirapine (BI-RG-587) plasma levels in HIV-infected children; to assess the safety and tolerance of single rising oral doses of nevirapine in HIV-infected children; and to confirm that the single doses that achieve certain plasma levels in adults achieve similar levels in HIV-infected children.
Test tube studies have shown that nevirapine (BI-RG-587) inhibits replication (reproduction) of HIV. Nevirapine works with zidovudine (AZT) and is active against strains of the virus that are resistant to AZT. Studies of the drug in HIV-infected adults showed no serious adverse effects.
Condition | Intervention |
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HIV Infections |
Drug: Nevirapine |
Study Type: | Interventional |
Study Design: | Treatment, Dose Comparison, Safety Study |
Official Title: | A Pilot Pharmacokinetic Phase I Evaluation of BI-RG-587 in HIV-Infected Children |
Estimated Enrollment: | 6 |
Test tube studies have shown that nevirapine (BI-RG-587) inhibits replication (reproduction) of HIV. Nevirapine works with zidovudine (AZT) and is active against strains of the virus that are resistant to AZT. Studies of the drug in HIV-infected adults showed no serious adverse effects.
Two doses, given by mouth, are evaluated: Three patients receive the lower dose, and 7 days after the third patient receives the lower dose, three additional patients receive the higher dose. After dosing, blood is drawn at 1, 2, 4, 8, 24, 48, 96, 168 hours to measure blood levels of the drug.
Ages Eligible for Study: | 2 Months to 13 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have the following:
Exclusion Criteria
Concurrent Medication:
Excluded:
Excluded within 1 hour before and 4 hours after study drug administration:
Concurrent Treatment:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded:
Excluded for at least 4 weeks prior to drug administration:
Prior Treatment:
Excluded:
Patients may not have the following:
Zidovudine (AZT) > 7 days prior to administration of study drug.
Active alcohol or drug abuse.
Study ID Numbers: | ACTG 165, 00853 |
Study First Received: | November 2, 1999 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00000634 |
Health Authority: | United States: Federal Government |
Benzodiazepines Drug Evaluation Drugs, Investigational Acquired Immunodeficiency Syndrome Antiviral Agents |
Virus Diseases Nevirapine Sexually Transmitted Diseases, Viral HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Anti-HIV Agents Molecular Mechanisms of Pharmacological Action Immune System Diseases Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |