A Double-Blind, Randomized, Placebo-Controlled Phase I Study to Compare the Pharmacokinetics of Intravaginal Dapivirine Gel 4750, 0.05%, 2.5g and Dapivirine Gel 4789, 0.05%, 2.5g Formulations and to Assess the Safety as Compared to the Intravaginal HEC [hydroxyethylcellulose]-Based Universal Placebo Gel, 2.5g in Healthy HIV-Negative Women.

Trial Profile

A Double-Blind, Randomized, Placebo-Controlled Phase I Study to Compare the Pharmacokinetics of Intravaginal Dapivirine Gel 4750, 0.05%, 2.5g and Dapivirine Gel 4789, 0.05%, 2.5g Formulations and to Assess the Safety as Compared to the Intravaginal HEC [hydroxyethylcellulose]-Based Universal Placebo Gel, 2.5g in Healthy HIV-Negative Women.

Completed
Phase of Trial: Phase I

Latest Information Update: 22 Jun 2010

At a glance

  • Drugs Dapivirine (Primary)
  • Indications HIV infections
  • Focus Adverse reactions; Pharmacokinetics
  • Most Recent Events

    • 22 Jun 2010 Results have been published in the Journal of Acquired Immune Deficiency Syndromes.
    • 11 Feb 2009 Results have been presented at CROI 2009.
    • 25 Feb 2008 New trial record.
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