Clinical trial

Safety, Tolerability and Pharmacokinetics of Efavirenz in HIV-Infected Children

NCT00364793 · Bristol-Myers Squibb, Industry · Completed

Key facts

NCT number NCT00364793
Title Safety, Tolerability and Pharmacokinetics of Efavirenz in HIV-Infected Children
Official title An Open-label Study of Liquid and Sprinkled Formulations of Efavirenz Administered in Combination With Didanosine and Emtricitabine in HIV-infected Infants and Children 3 Months to 6 Years of Age.
Lead sponsor Bristol-Myers Squibb, Industry
Status Completed
Phase Phase 1/Phase 2
Study type Interventional
Conditions HIV Infections
Intervention type Drug
Interventions Efavirenz (EFV) + Didanosine (ddI) + Emtricitabine (FTC)
Enrollment 56
Start date Feb 1, 2007
Primary completion Dec 1, 2011
Completion Jul 1, 2013
First posted Aug 16, 2006
Last update posted Apr 29, 2014
Countries Argentina, Colombia, Mexico, Panama, South Africa, Thailand

At a glance

  • 10–99 Study sites
  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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