A Pilot Pharmacokinetic Phase I Evaluation of BI-RG-587 in HIV-Infected Children
Completed · Not applicable
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00000634
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 6
- Last updated by the study team
- 2011-03-01
Who can join
Age: 0 and older, up to 13. Sex: any. Healthy volunteers: not accepted.
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.
- 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.
Where it is running
- Univ of Massachusetts Med Ctr / Biotech II — Worcester, Massachusetts, United States
Full record on ClinicalTrials.gov
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