| 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
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.
NIAID is a component of the National Institutes of Health, an agency of the U.S.
Department of Health and Human Services. NIAID supports basic and applied research
to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other
sexually transmitted infections, influenza, tuberculosis, malaria and illness
from potential agents of bioterrorism. NIAID also supports research on transplantation
and immune-related illnesses, including autoimmune disorders, asthma and allergies.
News releases, fact sheets and other NIAID-related materials
are available on the NIAID Web site at http://www.niaid.nih.gov.