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

February 25, 2011 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • Univ of Massachusetts Med Ctr / Biotech II

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 13 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (ACTUAL)

June 1, 1995

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (ESTIMATE)

August 31, 2001

Study Record Updates

Last Update Posted (ESTIMATE)

March 1, 2011

Last Update Submitted That Met QC Criteria

February 25, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 165
  • 00853

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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