Status:
COMPLETED
A Pilot Pharmacokinetic Phase I Evaluation of BI-RG-587 in HIV-Infected Children
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
HIV Infections
Eligibility:
All Genders
2-13 years
Phase:
NA
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 ...
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 resistan...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00000634
Last Update
March 1 2011
Active Locations (1)
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1
Univ of Massachusetts Med Ctr / Biotech II
Worcester, Massachusetts, United States, 01605