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 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:

(Date:4/26/2016)... LONDON , April 26, 2016 ... a product subsidiary of Infosys (NYSE: ... to integrate the Onegini mobile security platform with ... ) The integration will ... to access and transact across channels. Using this ...
(Date:4/15/2016)... April 15, 2016  A new partnership announced ... accurate underwriting decisions in a fraction of the ... priced and high-value life insurance policies to consumers ... With Force Diagnostics, rapid testing (A1C, Cotinine ... readings (blood pressure, weight, pulse, BMI, and activity ...
(Date:4/13/2016)...  IMPOWER physicians supporting Medicaid patients in ... standard in telehealth thanks to a new partnership with ... IMPOWER patients can routinely track key health measurements, such ... and, when they opt in, share them with IMPOWER ... local retail location at no cost. By leveraging this ...
Breaking Biology News(10 mins):
(Date:6/23/2016)... , June, 23, 2016  The Biodesign Challenge ... envision new ways to harness living systems and biotechnology, ... Art (MoMA) in New York City ... 130 participating students, showcased projects at MoMA,s Celeste Bartos ... Paola Antonelli , MoMA,s senior curator of architecture and ...
(Date:6/23/2016)... ... 23, 2016 , ... STACS DNA Inc., the sample tracking software company, today ... Laboratory, has joined STACS DNA as a Field Application Specialist. , “I am ... and COO of STACS DNA. “In further expanding our capacity as a scientific integrator, ...
(Date:6/23/2016)... NEWPORT BEACH, Calif. , June 23, 2016 /PRNewswire/ ... offering new biological discoveries to the medical community, has ... and co-founder Matthew Nunez . "We ... provide us with the capital we need to meet ... funding will essentially provide us the runway to complete ...
(Date:6/23/2016)... ... June 23, 2016 , ... ClinCapture, the only ... Center and will showcase its product’s latest features from June 26 to June ... scientific poster on Disrupting Clinical Trials in The Cloud during the conference. ...
Breaking Biology Technology: