Search / Trial NCT00000634

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Trial Information

Current as of November 14, 2024

Completed

Keywords

Benzodiazepines Drug Evaluation Drugs, Investigational Acquired Immunodeficiency Syndrome Antiviral Agents

ClinConnect Summary

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.

Gender

ALL

Eligibility 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.

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Worcester, Massachusetts, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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