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

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT00001111
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
1 Day - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Nevirapine — DRUG
  • Zidovudine — DRUG

Study Details

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 Dates

Status verified
Feb 2011
Primary completion
Jun 30, 1995

Study Design

Enrollment
35 participants
Primary purpose
TREATMENT

Locations (7)

FacilityCityStateZIPSite coordinators
UCLA Med Ctr / PediatricsLos AngelesCalifornia90095-
Univ of Southern California / LA County USC Med CtrLos AngelesCalifornia900331079-
Univ of Connecticut Health Ctr / PediatricsFarmingtonConnecticut06032-
Univ of Miami (Pediatric)MiamiFlorida33161-
Baystate Med Ctr of SpringfieldSpringfieldMassachusetts01199-
Univ of Massachusetts Med Ctr / Biotech IIWorcesterMassachusetts01605-
Children's Hosp of New Jersey / UMDNJ - New Jersey Med SchlNewarkNew Jersey071072198-

Find similar trials in Los Angeles, CA

By condition
HIV
By specialty
Infectious disease
By research site
UCLA Med Ctr / Pediatrics· Los Angeles, CAUniv of Southern California / LA County USC Med Ctr· Los Angeles, CAUniv of Connecticut Health Ctr / Pediatrics· Farmington, CTUniv of Miami (Pediatric)· Miami, FLBaystate Med Ctr of Springfield· Springfield, MAUniv of Massachusetts Med Ctr / Biotech II· Worcester, MA

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