Tenofovir

Tenofovir Clinical Trials

CONRAD Clinical Studies: Completed


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 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

Completed – in data analysis

90 women

 

CONRAD Clinical Studies: Active

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 117

PK/PD and Safety Study of TFV, Emtricitabine (FTC), and TFV/FTC Vaginal Tablets

Assessing safety, PK/PD, and acceptability of TFV, FTC, and TFV/FTC vaginal tablets

EVMS

Albert Einstein College of Medicine

Ongoing

Start: Q1 2013

48 women

CONRAD 124

Effect of Reproductive Cycle and Menopause on HIV Susceptibility and TFV Gel Activity

Assessing influence of reproductive cycle and menopause on HIV susceptibility and TFV gel activity

EVMS

Ongoing

Start: Q3 2013

40 women

 

CONRAD Clinical Studies: Pending

Title and Protocol #

Summary

Site(s)

Status

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: Q4 2013

45 women

CONRAD 122

Postcoital Testing of TFV Gel/SILCS Diaphragm

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

EVMS

TBD

Protocol in development

Start: 2014

CONRAD 123

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

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

EVMS

TBD

Protocol in development

Start: 2014

CONRAD 128

PK/PD and Safety Study of TFV and TFV/Levonorgestrel (LNG) Intravaginal Rings (IVRs)

Assessing safety and PK/PD of the TFV and TFV/LNG IVRs

EVMS

TBD

Pending

Start: Q4 2013

90 women


 

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