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:6/25/2017)... ... June 25, 2017 , ... CareSet Labs released the Root ... Orleans. This is a new, greatly improved version of the Doctor Referral teaming dataset ... by Fred Trotter and subsequently called the the “Doctor Referral Dataset” as released by ...
(Date:6/24/2017)... York (PRWEB) , ... June 24, 2017 , ... ... the Dental365 family. Located at 217 Portion Road in Lake Ronkonkoma, Dental365 offers ... evenings and weekends so that visits to the dentist fit into their patients’ ...
(Date:6/23/2017)... ... 23, 2017 , ... By scoring 100% for fiscal management and accountability, the ... online charity evaluator, Charity Navigator, validating ANRF's work as a top charity in America. ... Charity Navigator and earns ANRF a spot on their “ 10 Charities Worth Watching ...
(Date:6/23/2017)... ... 2017 , ... Military Connection friend and veteran advocate Micaela Bensko ... Atlantic lounge. , Bensko is no stranger to the plight of the disabled. ... life to supporting our wounded veterans. A world-class photographer, her riveting photos “The Wounds ...
(Date:6/23/2017)... ... 2017 , ... Georgia State University will host the First ... two-day conference is focused on advancing scientific knowledge about the aggressive triple negative ... racial breast cancer-related disparities. The conference theme is “Illuminating Actionable Biology.” , Conference ...
Breaking Medicine News(10 mins):
(Date:6/9/2017)... , June 9, 2017 AirXpanders, Inc. (ASX: ... on the design, manufacture, sale and distribution of the ... the progress of its commercial roll-out in ... in more than one hundred (100) medical institutions and ... AeroForm offers a needle-free alternative for women who choose ...
(Date:6/7/2017)... Endo International plc (NASDAQ: ENDP ) today ... R. Goodwin , U.S. District Court Judge for the ... entered a case management order in MDL 2325, American ... (the "MDL") that includes a provision requiring plaintiffs in ... specific causation within one hundred twenty (120) days of ...
(Date:6/3/2017)... , June 3, 2017  Eli Lilly and ... that results from the Phase 3 MONARCH 2 ... & 6 inhibitor, in combination with fulvestrant, significantly ... fulvestrant alone in women with hormone-receptor-positive (HR+), human ... cancer who have relapsed or progressed after endocrine ...
Breaking Medicine Technology: