Phase I Safety and Acceptability of Tenofovir 1% Gel in Adolescent Females

NCT02245945 Phase 1 WITHDRAWN

The purpose of this trial is to assess the safety and acceptability of Tenofovir (TFV) 1% gel in adolescent females over 12 weeks of a minimum of twice weekly dosing following the BAT24 regimen.

Details

Lead sponsor	CONRAD
Phase	Phase 1
Status	WITHDRAWN

Conditions

• HIV Prevention

Interventions

• TFV 1% vaginal gel
• HEC Placebo Gel

Primary outcomes

• Changes in genitourinary adverse events (AEs) — 24 hours after single dose; 1, 2, 4, 8 and 12 weeks during/after repeat dosing
  Number of genitourinary adverse events (AEs)
• Changes in soluble markers of inflammation in cervicovaginal fluid (CVF) — Baseline; 24 hours after single dose; 12 weeks after repeat dosing
  changes in soluble markers of inflammation in cervicovaginal fluid (CVF)
• Changes in vaginal microflora as assessed by Gram stain and semi-quantitative vaginal culture — Baseline and 12 weeks after repeat dosing
  Changes in vaginal microflora as assessed by Gram stain and semi-quantitative vaginal culture

Countries

United States