May 16, 2011
www.conrad.org
 

CONRAD NEWS

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Tenofovir Gel Updates

Regulatory work toward registration for 1% tenofovir gel in the U.S. and South Africa continues to be our highest priority.  CONRAD's clinical team is working on an expanded PK/PD study that will compare various dosing regimens and we are working with our colleagues in the field to go forward with clinical trials requested by the FDA, including:  

  • Safety in adolescents (MTN-021, FACTS002)
  • Drug-drug interaction in which our scientists examine how 1% tenofovir gel interacts with antifungal agents 

We are developing innovative applicators, including a paper applicator (with the Program for Appropriate Technology in Health [PATH]) and also with PATH, investigating the use of the SILCS diaphragm as a method of delivery.  Additionally, CONRAD is working with manufacturers of tenofovir gel to provide clinical supplies for FACTS001 and FACTS002, MTN studies, CAPRISA 008, and an Australian acceptance study that will be conducted by the University of New South Wales.

Other tenofovir activities in the pipeline include the development of innovative dosage forms such as intravaginal rings, fast dissolving tablets, and multipurpose prevention technologies which combine tenofovir with a contraceptive (levonogesterol).  

Pharmacokinetic and Pharmacodynamic (PK/PD) Study of Tenofovir 1% Gel

This clinical study will obtain data on PK/PD and the immune system effects of tenofovir 1% gel when used in different dosing regimens (BAT 24 [before intercourse, after intercourse and no more than two doses within 24 hours], daily, precoital and postcoital). CAPRISA 004 showed use of tenofovir 1% gel in the BAT24 regimen to be 39% effective in preventing HIV transmission; data from this study (along with data from other studies) will help scientists identify the most effective dosing regimen

CONRAD Clinical Trial Updates

TU/Net-En 

A contraceptive effectiveness trial of a hormone-based method for male contraception will be ending early, based on the recommendation made as part of the standard annual research project review process at the World Health Organization (WHO).  A collaboration between WHO and CONRAD, this Phase II study was designed to evaluate whether the combination of a long-acting progestin, norethisterone enantate (NET-EN), and a long-acting androgen, testosterone undecanoate (TU), represents a safe and effective method of male fertility regulation.  The review panel’s recommendations to discontinue injections and transition participants to the recovery phase were made based on their determination that the risks of possible side effects might outweigh the potential benefits to the male study participants. Participants are currently being transitioned off the study medication and will be followed until recovery of sperm to levels generally considered fertile. 

This trial could not have been implemented without the willingness of the male participants to take part in furthering development of a method for all men and the dedication and hard work of the principal investigators and study team. For more information on the TU Net-En trial, please click here.

Woman's Condom

Since 1998, CONRAD has supported the Program for Appropriate Technology in Health (PATH) in the development of a new female condom called the Woman's Condom. The Woman's Condom was designed with input from women and their partners; unique features include a dissolving capsule to facilitate insertion and foam ovals that anchor the condom in place. A CONRAD-sponsored clinical trial comparing self-reported failure rates of the Woman's Condom and the FC2 Female Condom (the only female condom commercially available today) is almost complete. In this trial, prostate-specific antigen (PSA) is also being measured and will serve as an objective indicator of condom failure. All participants have been enrolled and should complete the study by the fall of this year. In parallel, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is conducting a Phase III contraceptive efficacy trial of the Woman's Condom; enrollment began in January 2011. The results of these two trials will be used to support FDA approval of the Woman's Condom. Additionally, it is hoped that linking the results from these two trials will simplify the regulatory pathway for future female condoms.

News in the Field

HPTN 052 Study Shows 96% Reduction in HIV Transmission

HIV infected individuals who are treated early with antiretrovirals are 96% less likely to infect their HIV negative partners.  The HPTN 052 study, conducted by the HIV Prevention Trials Network in Africa, Asia and the Americas, was designed to evaluate whether immediate versus delayed use of antiretrovirals in HIV positive individuals would decrease transmission of HIV to their uninfected partners.   This study was the first randomized clinical trial to prove unequivocally that treating HIV infected individuals with antiretrovirals as soon as possible is a prevention tool that can be used, along with other methods, to reduce HIV incidence around the world. 

CONRAD congratulates the study principal investigator, Dr. Mike Cohen, HPTN principal investigator Sten Vermund and their colleagues for this very significant contribution to the field of HIV prevention.  For more information, please click here for the HPTN press release. 

FEM-PrEP

CONRAD commends the FHI FEM-PrEP study team for conducting a highly professional trial that will provide important data about the use of oral antiretrovirals in women to the field.  Please click here for CONRAD's statement.