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

NCT00000634 | Completed

• 2 other identifiers: ACTG 16500853
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections

Keywords

Benzodiazepines; Drug Evaluation; Drugs, Investigational; Acquired Immunodeficiency Syndrome; Antiviral Agents

Interventions

Nevirapine DRUG

Eligibility Criteria

• Age: 2 Months - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Univ of Massachusetts Med Ctr / Biotech II

Worcester, Massachusetts, 01605, United States

Location

Related Publications (1)

• Luzuriaga K, Bryson Y, McSherry G, Robinson J, Stechenberg B, Scott G, Lamson M, Cort S, Sullivan JL. Pharmacokinetics, safety, and activity of nevirapine in human immunodeficiency virus type 1-infected children. J Infect Dis. 1996 Oct;174(4):713-21. doi: 10.1093/infdis/174.4.713.

  PMID: 8843207 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Nevirapine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Primary Completion: June 1, 1995
• Last Updated: March 1, 2011

Record last verified: 2011-02

Locations

US (1)