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

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Trial Information

Current as of December 10, 2023

Completed

Keywords

Benzodiazepines Drug Evaluation Drugs, Investigational Acquired Immunodeficiency Syndrome Antiviral Agents

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.

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.

Attachments

readout_NCT00000634_2023-12-10.pdf

4.5 MB

NCT00000634_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Worcester, Massachusetts, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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