Navigation Links
International trial of two microbicides begins

A large, multisite trial designed to examine the safety and preliminary effectiveness of two candidate topical microbicides to prevent HIV infection has opened to volunteer enrollment. The trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, represents a partnership among various research institutions in Africa and the United States.

Although no licensed microbicides are available to the public currently, scientists hope these agents--designed to be applied to the surface of the vagina to prevent sexually transmitted infections (STIs)--will one day be a key tool in the fight against HIV/AIDS.

Women make up nearly half of all people living with HIV worldwide. "The majority of new cases of HIV infection in women result from heterosexual intercourse, but women may not always be able to insist that their male partners use measures to prevent HIV transmission," notes NIAID Director Anthony S. Fauci, M.D. "If effective, microbicides would be a valuable woman-controlled means of slowing the pace of the HIV/AIDS epidemic," Dr. Fauci adds.

The first volunteers were enrolled this week at sites in Durban, South Africa, and at the University of Pennsylvania in Philadelphia. Enrollment will begin shortly at sites in four additional African countries--Malawi, Tanzania, Zimbabwe and Zambia. Approximately 3,220 women will be enrolled in the trial, which is expected to last approximately 30 months.

"This is the first microbicide safety and effectiveness trial of this magnitude to be conducted by NIAID," says Roberta J. Black, Ph.D., Topical Microbicide Team Leader in NIAID's Division of AIDS. "It is a critical trial evaluating two topical microbicides with differing mechanisms of action," she adds.

The microbicides to be tested are PRO 2000 and BufferGel. Produced by Indevus Pharmaceuticals, Lexington, MA, PRO 2000 has shown activity against HIV and other STIs in both laboratory and animal testing. It is believed to act by inhibiting the entry of HIV and other pathogens into body cells. BufferGel, a product of ReProtect, Inc., Baltimore, MD, boosts the natural acidity of the vagina in the presence of seminal fluid that neutralizes the vaginal environment. An acidic environment inactivates HIV as well as other pathogens.

Each woman in the trial will be placed at random into one of four equally sized groups. One group will use BufferGel before each act of sexual intercourse, one group will use PRO 2000, one group will use a placebo gel, and the final group will not use any gel. In addition, all participants will receive condoms and extensive prevention counseling at each clinic visit.

The trial is one of numerous studies conducted through NIH's HIV Prevention Trials Network (HPTN), which is funded by NIAID, the National Institute of Child Health and Human Development, the National Institute on Drug Abuse and the National Institute of Mental Health. More information about this study (HPTN 035) is available at www.hptn.org/index.htm. The protocol chair of the study is Salim Abdool Karim, MBChB, Ph.D., of the University of KwaZulu-Natal in Durban, South Africa.


'"/>

Source:NIH/National Institute of Allergy and Infectious Diseases


Related biology news :

1. International HapMap consortium expands mapping effort
2. Solutions that reduce death of marine life reeled in by International Smart Gear Competition
3. International Team Determines Geographic Origin of Leprosy
4. International HIV/AIDS trial finds continuous antiretroviral therapy superior to episodic therapy
5. International team analyzes human genetic variation in key immune region
6. Use of PET can reduce, may eliminate more strenuous drug development trials with animals
7. HIV vaccine trial breaks ground for future research
8. Roche clinical trial registry and results database launched
9. NIAID begins clinical trial of West Nile virus vaccine
10. Moffitt-USF head toward first human trials of anti-cancer drug that targets protein AKT
11. Compound might defeat African sleeping sickness, clinical trial beginning this month
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:1/12/2017)... NEW YORK , Jan. 12, 2017  New research ... around the office of the future.  1,000 participants were simply ... last three months which we may consider standard issue.  Insights ... office of 2017 were also gathered from futurists and industry ... and Dr. James Canton .  Some ...
(Date:1/11/2017)... DES MOINES, Iowa , Jan. 11, 2017 /PRNewswire/ ... another industry first with the release of its patent-pending ... to quickly and reliably perform calibrations, securely upload data ... more flexibility for the customer. "Fighting drunk ... not only for the public at large, but also ...
(Date:1/6/2017)... 2017  Privately-held CalciMedica, Inc., announced that it ... of a novel calcium release-activated calcium (CRAC) channel ... Acute pancreatitis, sudden painful inflammation of ... can be very serious.  In severe cases it can ... hospital stays, time in the ICU and substantial ...
Breaking Biology News(10 mins):
(Date:1/18/2017)... Maryland (PRWEB) , ... January 18, 2017 , ... ... two new federally funded bio-focused Manufacturing Innovation Institutes (MII). U.S. Secretary of Commerce ... in Manufacturing Biopharmaceuticals (NIIMBL), and the Department of Defense has announced the award ...
(Date:1/18/2017)... ... 2017 , ... Researchers from a new study are stating that if levels of ... cancer treatment, this indicates there is still remaining prostate cancer cells that are more likely ... test has always been an indicator of whether a man’s prostate cancer is growing ...
(Date:1/18/2017)... ... January 18, 2017 , ... ... to sell research and genetic testing lab equipment from two different leading institutes. This ... and Northeast regions of the United States. This 1-day online auction will take ...
(Date:1/18/2017)... , ... January 18, 2017 , ... Thirty-six startup companies ... credits by the Pennsylvania Department of Community and Economic Development in 2016 as part ... located in the University City Keystone Innovation Zone and represent the highest number of ...
Breaking Biology Technology: