October 12, 2012
www.conrad.org
 

CONRAD NEWS

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CONRAD in the News

CONRAD's Deputy Director of Programs, Dr. Doug Colvard, was recently quoted in a Chemical and Engineering News article on male contraceptives: Hunt For The Male Contraceptive Pill Continues Despite Decades Of Research.

Clinical Trial Updates

FACTS 001 Study -  We are past the halfway point for enrollment - close to 1700 women at 9 sites in South Africa are currently participating in the study. This Phase III trial is testing the safety and effectiveness of vaginal tenofovir (TFV) gel when used before and after sex to reduce HIV and herpes simplex virus-2 (HSV-2) infections. The study needs to enroll a total of 2,600 women aged 18-30 years and 300 women aged 31-40 years at sites in South Africa. Each woman will participate in the study for up to 2 years. 

TU/NET EN Study - Results and completion of data analysis for the testosterone (TU)/norethisterone-enanthate (NET-EN) male hormonal contraceptive effectiveness trial are on track to be completed by the end of 2012.

Product Development Updates

Tenofovir and Tenofovir/Emtricitabine Vaginal Tablets - Vaginal tablets are small and easy to store, can be used without a partner’s knowledge and are inexpensive. CONRAD is developing vaginal tablets containing either TFV alone or TFV combined with emtricitabine (FTC), the same combination in the antiretroviral pill Truvada. Currently, CONRAD staff is working on investigational new drug applications (INDs) for the Food and Drug Administration (FDA) to support the vaginal tablets clinical trial.

Tenofovir Intravaginal Ring - CONRAD is committed to the development of a sustained release intravaginal ring (IVR) for TFV. This product is designed to release TFV over the course of 90 days. This new IVR is based on the use of a novel biocompatible polyurethane thermoplastic designed specifically to control the release of TFV. FDA documents for the TFV IVR are in development.

Tenofovir Gel for Rectal Use - CONRAD is collaborating with the Microbicide Trials Network (MTN) to develop a TFV gel for rectal use. In early studies of the TFV vaginal gel used rectally, some participants experienced gastrointestinal distress, so CONRAD scientists reformulated the gel by reducing the osmolality in hopes of reducing this side effect. Early results from the MTN-007 study indicate that the reduced-glycerin gel is safe and well-tolerated. An amendment to the TFV gel IND to support MTN-017 has been submitted. 

SILCS Diaphragm plus Reformulated Tenofovir Gel - CONRAD scientists are reformulating TFV gel with enhanced contraceptive properties. This new gel will be used with the SILCS diaphragm to prevent pregnancy, HIV, and HSV-2. After successful formulation, the new gel will be tested for safety and efficacy in animals. If results from the animal trials are favorable, the combination will then be tested simultaneously in humans in a postcoital test (to determine if sperm are present in a woman’s mid-cycle mucus after sex while using the SILCS plus TFV) and in a safety and pharmacokinetic (PK)/pharmacodynamic (PD) trial.

Publications

Antimicrobial Agents and Chemotherapy: A ninety day tenofovir reservoir intravaginal ring for mucosal HIV prophylaxis. CONRAD contributing authors - Gustavo Doncel, MD, PhD, David Friend, PhD, and  Meredith Clark, PhD. Read the article here.

Journal of Controlled Release: Quantitative evaluation of a hydrophilic matrix intravaginal ring for the sustained delivery of tenofovir. CONRAD contributing authors - David Friend, PhD and Meredith Clark, PhD. Read the article here.

Drug Delivery and Translational Research: Development of a UC781 releasing polyethylene vinyl acetate ring. CONRAD contributing authors - David Friend, PhD and Meredith Clark, PhD. Read the article here.

International Journal of STD & AIDS: Herpes Simplex Virus and HIV: genital infection synergy and novel approaches to HIV prevention.  CONRAD contributing authors, Andrea Thurman, MD and Gustavo Doncel, MD, PhD.  Read the article here.