A Study of Nevirapine Used Alone or in Combination With AZT in HIV-1-Infected Children
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
2 other identifiers
interventional
35
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv-infections
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Primary Completion
Last participant's last visit for primary outcome
June 1, 1995
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedMarch 1, 2011
February 1, 2011
November 2, 1999
February 28, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
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.
- +24 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079, United States
UCLA Med Ctr / Pediatrics
Los Angeles, California, 90095, United States
Univ of Connecticut Health Ctr / Pediatrics
Farmington, Connecticut, 06032, United States
Univ of Miami (Pediatric)
Miami, Florida, 33161, United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199, United States
Univ of Massachusetts Med Ctr / Biotech II
Worcester, Massachusetts, 01605, United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, 071072198, United States
Related Publications (3)
Luzuriaga K, Bryson Y, Krogstad P, Robinson J, Stechenberg B, Lamson M, Cort S, Sullivan JL. Combination treatment with zidovudine, didanosine, and nevirapine in infants with human immunodeficiency virus type 1 infection. N Engl J Med. 1997 May 8;336(19):1343-9. doi: 10.1056/NEJM199705083361902.
PMID: 9134874BACKGROUNDSullivan J, Luzuriaga K. Nevirapine activity and emergence of resistant virus in pediatric trials. The ACTG 180 Study Team. Int Conf AIDS. 1993 Jun 6-11;9(1):475 (abstract no PO-B26-2042)
BACKGROUNDLuzuriaga K, Bryson Y, McSherry G, Robinson J, Stechenberg B, Scott G, Lamson M, Cort S, Sullivan JL. Pharmacokinetics, safety, and activity of nevirapine in human immunodeficiency virus type 1-infected children. J Infect Dis. 1996 Oct;174(4):713-21. doi: 10.1093/infdis/174.4.713.
PMID: 8843207BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
J Sullivan
- STUDY CHAIR
K Luzuriaga
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Primary Completion
June 1, 1995
Last Updated
March 1, 2011
Record last verified: 2011-02