A Phase I Trial to Assess the Safety of Tenofovir Gel and Film Formulations: FAME 04

PHASE1CompletedINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

January 31, 2015

Study Completion Date

January 31, 2015

Conditions
HIV
Interventions
DRUG

1% vaginally applied tenofovir gel

DRUG

Tenofovir film- 10mg

DRUG

Tenofovir Film-40 mg

OTHER

HEC Placebo Gel

OTHER

Placebo Vaginal Film

Trial Locations (1)

15213

Magee-Womens Hospital of UPMC, Pittsburgh

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

National Institutes of Health (NIH)

NIH

lead

CONRAD

OTHER

NCT01989663 - A Phase I Trial to Assess the Safety of Tenofovir Gel and Film Formulations: FAME 04 | Biotech Hunter | Biotech Hunter