A Phase 1 Crossover Trial Evaluating the Pharmacokinetics of Tenofovir Reduced-Glycerin 1% Gel in the Rectal and Vaginal Compartments in Women

NCT01768962 Phase 1 COMPLETED

To compare local and systemic pharmacokinetics of tenofovir reduced-glycerin (TFV RG) 1% gel after 2 weeks of daily rectal use and after 2 weeks of daily vaginal use

Details

Lead sponsor	CONRAD
Phase	Phase 1
Status	COMPLETED
Enrolment	14
Start date	2014-04
Completion	2014-12

Conditions

• HIV Prevention

Interventions

• Once Daily Application of TFV RG 1% Gel - Vaginal
• Once Daily Application of TFV RG 1% gel - Rectal
• Once Daily Application of TFV RG 1% gel - Rectal
• Once Daily Application of TFV RG 1% Gel - Vaginal

Primary outcomes

• Drug concentrations — 10 weeks
  To compare local and systemic pharmacokinetics of tenofovir reduced-glycerin 1% gel after 2 weeks of daily rectal use and after 2 weeks of daily vaginal use

Countries

United States