Navigation Links
Trial of VivaGel in Sexually Active Young Women Commences

Starpharma Holdings Limited announced the commencement in the U.S. of a trial to assess the safety and acceptability of SPL7013 Gel (VivaGel(TM)) in sexually active young women.

The Microbicide Trials Network (MTN) is leading the study, funded by the U.S. National Institutes of Health (NIH), in which VivaGel(TM) will be tested for the first time in sexually active young women to determine its safety, acceptability and ease of use. VivaGel(TM) is being developed as a vaginal microbicide for the prevention of HIV and genital herpes.

The expanded safety study is being conducted at the University of South Florida in Tampa, Florida, and the University of Puerto Rico in San Juan, Puerto Rico, through a collaboration between the MTN (an HIV/AIDS clinical trials network established by the National Institute of Allergy and Infectious Diseases, NIH), the Adolescent Medicine Trials Network for HIV/AIDS Interventions (of the National Institute of Child Health and Human Development, NIH), and Starpharma.

Nearly 50 percent of people infected with HIV/AIDS today are women and most of them become infected through sexual intercourse with male partners. Women under the age of 25 are particularly at risk of infection.

"We have already conducted clinical trials on the safety of VivaGel(TM) in sexually inactive women and men, but this is the first time the product will be used in sexually active young women, one of our target populations. This study, in addition to the usual safety data, will collect valuable information regarding the product's use and acceptability in the consumer setting," said Dr Jackie Fairley, Chief Executive Officer of Starpharma.

"The data from this trial will provide information of value to the development of VivaGel(TM) for all indications, including preventing the spread of genital herpes," added Dr Fairley.

The study will enroll 40 sexually active, HIV-negative women aged 18 t o 24 years. Participants will be randomly assigned to one of two study groups. One group will apply VivaGel(TM) twice a day for two weeks and the other will apply a placebo gel.

The safety of VivaGel(TM) compared with the placebo will be assessed by laboratory tests and clinical examination of the participants.

Product acceptability assessments in the trial will provide very useful and product-specific preliminary information to add to the growing body of data supporting the attractiveness of topical gel microbicides in this consumer group.

The importance of topical microbicides is highlighted by statistics from UNAIDS and the U.S. Centers for Disease Control and Prevention that show 48 percent of the 39.5 million people living with HIV/AIDS are women, and among 15- to 24- year-olds with HIV, females account for 60 percent. In the U.S., 43 percent of AIDS cases in the 13- to 19-year-old age group are female.


'"/>




Related medicine news :

1. Results Of Human Trials Of Hungarian Bird-Flu Vaccine Expected Today
2. Vaccine For Dengue Fever On Trial In Asia-Pacific
3. DNA Vaccine Trials Against HIV Virus In Sweden Nurture Hope
4. Clinical Trials of New Drug Febuxostat Show Promise in Gout Treatment
5. Sex, Race Influence Lung Cancer Trial Participation
6. Clinical Trials Of New Anti-Cancer Drug To Be Initiated In New Zealand
7. Diarrhea Vaccine Trials Promises Prevention of Rotavirus Infection
8. New Generation Clinical Trials Could Save Time And Money, Improve Patient Care
9. China Begins Human Trials For HIV/AIDS Drug
10. Patients Should Be Entitled to "Humane Compensation" if Drug Trials Go Wrong
11. HIV/AIDS Vaccine Trial To Be Initiated Soon
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:10/13/2017)... ... October 13, 2017 , ... The American Board of Family Medicine's ... President and Chief Executive Officer, succeeding Dr. James C. Puffer upon his retirement. Dr. ... 2018 until Dr. Puffer’s retirement at the end of 2018. Upon assuming the role ...
(Date:10/13/2017)... Shelton, CT (PRWEB) , ... October 13, 2017 , ... ... and long-term care services, staged a mock evacuation of the facility as part of ... Department, Shelton Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well ...
(Date:10/13/2017)... Texas (PRWEB) , ... October 13, 2017 , ... Yisrayl ... this week that explains one of the most popular and least understood books in ... like cryptic and puzzling descriptions that have baffled scholars for centuries. Many have tossed ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... healthcare compliance program management, will showcase a range of technology and learning solutions ... Living (NCAL) Convention and Expo to be held October 14–18, 2017 at the ...
(Date:10/12/2017)... ... ... The American College of Medical Informatics (ACMI) will present the 2017 Morris F. ... AMIA’s Annual Symposium in Washington, D.C. AMIA’s Annual Symposium is taking place ... the field of medical informatics, this prestigious award is presented to an individual whose ...
Breaking Medicine News(10 mins):
(Date:10/4/2017)... OBP Medical , a leading ... today announced regulatory approval from Brazil,s ... Nacional de Vigilância Sanitária (ANVISA)) to market ... with integrated LED light source and smoke evacuation ... of a tissue pocket or cavity during surgical ...
(Date:10/2/2017)... The Rebound mobile app is poised to become a vital ... prescription drug addiction. The app empowers users to develop an ... their dosage in a safe, controlled manner while maximizing well-being. ... 100,000 people to sign up will enjoy 3 months of ... ...
(Date:9/25/2017)... 2017   Montrium , an industry leader ... the IQPC Trial Master Files & Inspection Readiness ... EastHORN Clinical Services has selected eTMF Connect ... management. EastHORN, a leading European contract research organization ... transparency to enable greater collaboration with sponsors, improve ...
Breaking Medicine Technology: