Tenofovir

Tenofovir Gel Current Studies

CONRAD Clinical Studies: Active

Title and Protocol #

Summary

Site(s)

Status

CONRAD 113

Pharmacokinetics (PK)/Pharmacodynamics (PD) Study of Tenofovir (TFV) Gel

Assessing local (vaginal) and systemic (blood) levels of TFV with different gel dosing regimens: before and after sex, before sex, after sex, and daily

Eastern Virginia Medical School (EVMS)

PROFAMILIA

University of Pittsburgh

Advances in Health

University of Pennsylvania

Will be completed in May

90 women

CONRAD Clinical Studies: Pending

Title and Protocol #

Summary

Site(s)

Status

CONRAD 114

Effects of Contraception and Menstrual Cycle on PK/PD and Vaginal Safety in TFV Gel Users

Effects of Depo-Provera, oral contraceptives and the menstrual cycle on PK/PD and safety of TFV gel

EVMS

PROFAMILIA

University of Pittsburgh

Ongoing

Start: Q1 2012

60 women

CONRAD 118

PK Study of TFV Gel with Three Commonly Used Vaginal Products

Interaction of TFV gel and antifungal cream, antimicrobial gel and contraceptive ring

University of California, San Francisco

Bronx-Lebanon Hospital

Pending

Start: target Q2 2013

45 women

CONRAD 117

PK/PD and Safety Study of TFV/FTC Vaginal Tablet

Assessing safety, PK/PD and acceptability of the combination TFV/FTC vaginal tablet

EVMS

TBD

Ongoing

Start: Q1, 2013

48 women

PK/PD and Safety Study of TFV Intravaginal Ring (IVR)

120

Assessing safety and PK/PD of TFV IVR

EVMS

Albert Einstein College of Medicine

Protocol in development

Start: pending, target Q4 2012

PK/PD and Safety Study of TFV/Levonorgestrel (LNG) IVR

121

Assessing safety and PK/PD of TFV/LNG IVR

EVMS

TBD

Protocol in development

Start: pending, target Q4 2012

Postcoital Testing of TFV Gel/SILCS Diaphragm

122

Assessing ability of TFV gel/SILCS diaphragm to prevent sperm from penetrating cervical mucous

EVMS

Protocol in development

Start: target 2013

PK/PD and Safety Study of TFV Gel/SILCS Diaphragm

123

Assessing safety and PK/PD of TFV gel/SILCS diaphragm

TBD

Protocol in development

Start: target 2013