A Study of Nevirapine Used Alone or in Combination With AZT in HIV-1-Infected Children

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Compounds with reverse transcriptase inhibitory activity that are more potent and less toxic than the nucleoside analogues are needed. Nevirapine (BI-RG-587) has shown in vitro inhibitory activity against HIV-1 reverse transcriptase and has shown a synergistic inhibition of HIV-1 replication when combined with zidovudine (AZT) in a plaque reduction assay.

Sixty mildly to moderately symptomatic HIV-infected children (five patients in each of four age groups) will receive oral nevirapine at 1 of 3 doses for 168 days. If preliminary activity is demonstrated and toxicity is acceptable after 84...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • IV gammaglobulin therapy.
• • Medications for PCP prophylaxis (e.g., TMP / SMX, dapsone, aerosolized and IV pentamidine).
• • Fluconazole.
• Patients must have:
• • HIV infection. A positive Polymerase Chain Reaction (PCR) is not acceptable as the sole evidence of HIV infection. Three out of five children in each age and dose group must have a serum p24 antigen level of 70 pg/ml or greater and/or a plasma viral titer of 50 TCID/ml or greater prior to study entry.
• • Ability to be followed by their original trial center for the duration of the trial.
• • Consent of parent or guardian.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms and conditions are excluded:
• • Lymphocytic interstitial pneumonitis if steroid-dependent or requiring supplemental oxygen or with a pretreatment paO2 \< 70 mm Hg.
• • Opportunistic or serious bacterial infections within 28 days prior to entry.
• • Demonstrated intolerance to zidovudine prior to administration of nevirapine (in patients enrolled in the combination therapy phase of the study).
• • CDC classification of P-2D (secondary infectious diseases) and/or P-2E (secondary cancers).
• • Pre-existing malignancies.
• Concurrent Medication:
• Excluded:
• • Other approved or investigational antiretroviral agents.
• • All other investigational agents (except fluconazole).
• • Glucocorticoids and steroid hormones.
• • Dicumarol, warfarin, and other anticoagulants.
• • Digitoxin.
• • Valproic acid.
• • Tolbutamide.
• • Doxycycline.
• • Chloramphenicol.
• • Isoniazid.
• • Phenobarbital and other barbiturates.
• • Hepatotoxic drugs.
• • Patients with prior participation in this trial are excluded.
• Prior Medication:
• Excluded:
• • More than 6 weeks of prior zidovudine (AZT) therapy or more than 6 weeks of any other antiretroviral therapy.
• Excluded within 7 days prior to study entry:
• • AZT (in monotherapy groups only).
• Excluded within 4 weeks prior to study entry:
• • Other approved or investigational antiretroviral agents.
• • All other investigational agents.
• • Glucocorticoids and steroid hormones.
• • Dicumarol, warfarin, and other anticoagulants.
• • Digitoxin.
• • Valproic acid.
• • Tolbutamide.
• • Doxycycline.
• • Chloramphenicol.
• • Isoniazid.
• • Phenobarbital and other barbiturates. Active alcohol or drug abuse to impair compliance with the protocol.

Trial Officials