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

Completed · Not applicable

Conditions studied: HIV Infections

In brief

Monotherapy phase: To evaluate and compare the safety, tolerance, pharmacokinetics, and preliminary activity of nevirapine administered alone in mildly to moderately symptomatic HIV-infected children ages 2 months to less than 18 years; to evaluate and compare the safety, tolerance, and pharmacokinetics of nevirapine in HIV-infected children ages 1 day to less than 2 months. Combination therapy phase: To evaluate and compare the safety, tolerance, pharmacokinetics, and preliminary activity of nevirapine administered in combination with zidovudine (AZT) in mildly to moderately symptomatic HIV-infected children ages 2 months to less than 18 years. 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-1reverse transcriptase and has shown a synergistic inhibition of HIV-1 replication when combined with zidovudine (AZT) in a plaque reduction assay.

Key facts

Study ID

NCT00001111

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

35

Last updated by the study team

2011-03-01

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Univ of Southern California / LA County USC Med Ctr — Los Angeles, California, United States
• UCLA Med Ctr / Pediatrics — Los Angeles, California, United States
• Univ of Connecticut Health Ctr / Pediatrics — Farmington, Connecticut, United States
• Univ of Miami (Pediatric) — Miami, Florida, United States
• Baystate Med Ctr of Springfield — Springfield, Massachusetts, United States
• Univ of Massachusetts Med Ctr / Biotech II — Worcester, Massachusetts, United States
• Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl — Newark, New Jersey, United States

Full record on ClinicalTrials.gov

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