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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Collaborator: |
Boehringer Ingelheim Pharmaceuticals |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000634 |
Purpose
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 |
|---|---|
|
HIV Infections |
Drug: Nevirapine |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
| Official Title: | A Pilot Pharmacokinetic Phase I Evaluation of BI-RG-587 in HIV-Infected Children |
| Estimated Enrollment: | 6 |
| Primary Completion Date: | June 1995 (Final data collection date for primary outcome measure) |
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.
Eligibility| 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.
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00000634 History of Changes |
| Other Study ID Numbers: | ACTG 165, 00853 |
| Study First Received: | November 2, 1999 |
| Last Updated: | February 25, 2011 |
| Health Authority: | United States: Federal Government |
|
Benzodiazepines Drug Evaluation Drugs, Investigational Acquired Immunodeficiency Syndrome Antiviral Agents |
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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 |