A Pilot Pharmacokinetic Phase I Evaluation of BI-RG-587 in HIV-Infected Children

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000634
First received: November 2, 1999
Last updated: February 25, 2011
Last verified: February 2011
  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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 6
Primary Completion Date: June 1995 (Final data collection date for primary outcome measure)
Detailed Description:

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
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Intravenous gammaglobulin. Pneumocystis prophylaxis according to published guidelines.

Patients must have the following:

  • HIV infection.
  • Parent or guardian must be available to give written informed consent.

Exclusion Criteria

Concurrent Medication:

Excluded:

  • Zidovudine (AZT).
  • Steroid dependency.

Excluded within 1 hour before and 4 hours after study drug administration:

  • Drugs that might interfere with the absorption of study drug (H2 blockers, antacids, carafate, cholestyramine).
  • Benzodiazepines.
  • Alcohol-containing substances.

Concurrent Treatment:

Excluded:

  • Requiring supplemental oxygen.

Patients with the following are excluded:

  • Active opportunistic or serious bacterial infection.
  • Lymphoid interstitial pneumonitis (LIP) and steroid dependent or requiring supplemental oxygen or have a pretreatment pa02 < 70 mm Hg.
  • Pre-existing malignancies.

Prior Medication:

Excluded:

  • Zidovudine (AZT) within 7 days prior to administration of study drug.

Excluded for at least 4 weeks prior to drug administration:

  • Other approved or investigational antiretroviral agents. All other investigational agents. Biologic response modifiers (e.g., interferon) or immunomodulators. Immunosuppressive agents (including glucocorticoids). Coumadin and other anticoagulant medications.

Prior Treatment:

Excluded:

  • Red blood cell transfusion within 4 weeks of study entry.

Patients may not have the following:

  • Opportunistic or serious bacterial infection.

Zidovudine (AZT) > 7 days prior to administration of study drug.

Active alcohol or drug abuse.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000634

Locations
United States, Massachusetts
Univ of Massachusetts Med Ctr / Biotech II
Worcester, Massachusetts, United States, 01605
Sponsors and Collaborators
Boehringer Ingelheim
  More Information

Additional Information:
Publications:
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

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Benzodiazepines
Drug Evaluation
Drugs, Investigational
Acquired Immunodeficiency Syndrome
Antiviral Agents

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on April 22, 2014