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
Trial Information
Current as of May 11, 2025
Completed
Keywords
ClinConnect Summary
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.
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Worcester, Massachusetts, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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