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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

November 2, 1999
February 25, 2011
Not Provided
June 1995   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00000634 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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A Pilot Pharmacokinetic Phase I Evaluation of BI-RG-587 in HIV-Infected Children
A Pilot Pharmacokinetic Phase I Evaluation of BI-RG-587 in HIV-Infected Children

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety Study
Primary Purpose: Treatment
HIV Infections
Drug: Nevirapine
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
Not Provided
June 1995   (final data collection date for primary outcome measure)

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.

Both
2 Months to 13 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000634
ACTG 165, 00853
Not Provided
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
Boehringer Ingelheim
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP