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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Roxane Laboratories |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001111 |
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.
Condition | Intervention |
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HIV Infections |
Drug: Nevirapine Drug: Zidovudine |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Pharmacokinetics, Safety, Tolerance, and Activity of Nevirapine (BI-RG-587) Alone and in Combination With AZT in Mildly to Moderately Symptomatic HIV-1 Infected Children |
Estimated Enrollment: | 35 |
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 days of treatment in the three oldest age groups (ages 2 months - less than 2 years, ages 2 years - less than 13 years, and ages 13 years - less than 18 years), children ages 1 day - less than 2 months will receive one of the three doses of nevirapine. Additionally, 15 additional patients (five in each of three age groups) will receive zidovudine in combination with nevirapine. At the end of 24 weeks of combination therapy, patients discontinue zidovudine for 2 weeks while remaining on nevirapine, in order for pharmacokinetic sampling to be done. Children will be enrolled sequentially by decreasing age and increasing nevirapine dose.
Ages Eligible for Study: | up to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Concurrent Medication:
Excluded:
Patients with prior participation in this trial are excluded.
Prior Medication:
Excluded:
Excluded within 7 days prior to study entry:
Excluded within 4 weeks prior to study entry:
United States, California | |
Univ of Southern California / LA County USC Med Ctr | |
Los Angeles, California, United States, 900331079 | |
UCLA Med Ctr / Pediatrics | |
Los Angeles, California, United States, 90095 | |
United States, Connecticut | |
Univ of Connecticut Health Ctr / Pediatrics | |
Farmington, Connecticut, United States, 06032 | |
United States, Florida | |
Univ of Miami (Pediatric) | |
Miami, Florida, United States, 33161 | |
United States, Massachusetts | |
Baystate Med Ctr of Springfield | |
Springfield, Massachusetts, United States, 01199 | |
Univ of Massachusetts Med Ctr / Biotech II | |
Worcester, Massachusetts, United States, 01605 | |
United States, New Jersey | |
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl | |
Newark, New Jersey, United States, 071072198 |
Study Chair: | J Sullivan | |
Study Chair: | K Luzuriaga |
Study ID Numbers: | ACTG 180, 882 |
Study First Received: | November 2, 1999 |
Last Updated: | July 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00001111 |
Health Authority: | United States: Federal Government |
Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Antiviral Agents Zidovudine Nevirapine |
Virus Diseases Nevirapine Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Zidovudine AIDS-Related Complex Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |