UCSF study will test new vaginal microbicide for herpes and HIV

November 30, 2006

A team of researchers at UCSF is seeking young women to participate in the first US study of the safety of a new a vaginal gel designed to prevent herpes and HIV infection. If it is effective and approved by the U.S. Food and Drug Administration, the gel would be an important weapon in the fight against HIV because it would allow women to protect themselves from infection rather than relying on their partners to use condoms.

"The significance of the gel is that it potentially gives the power back to the woman to protect herself against infection," said Anna-Barbara Moscicki, MD, professor of pediatrics at UCSF and lead investigator for the study.

The gel is not a contraceptive, but a microbicide. Microbicidal gels or creams are inserted into the vagina solely to prevent the spread of HIV and other sexually transmitted diseases. There are currently no such products on the market. Women who have herpes are at increased risk of contracting HIV, so diminishing the risk of getting herpes also diminishes the risk of HIV infection.

The generic name of the gel is "3 % w/w SPL7013" (brand name VivaGel). Following this safety trial, other trials will be conducted to determine its effectiveness at fighting off herpes and HIV infection. But Moscicki said that trials in animals have found the gel to be nearly 100 percent effective and have few side effects.

"There has been an important move supported by the National Institutes of Health and World Health Organization to support the development of vaginal microbicides," said Moscicki, who also is the director of Teen Clinics in the Division of Adolescent Medicine at UCSF Children’s Hospital. "Herpes infection is the number one attributable cause of HIV infection in the United States and worldwide."

The gel is designed to prevent herpes and HIV infection through the use of a molecule called a dendrimer. Dendrimers have molecular structures that resemble the branches of a tree. The herpes and HIV molecules are "caught" in the dendrimer branches and prevented from entering and infecting human cells, Moscicki said.

To participate in the study, women must be between 18 and 24 years old, sexually active, healthy and free of any sexually transmitted disease. They cannot be pregnant or breast feeding. They must either have regular menstrual periods or not have them at all.

Moscicki said that the safety trial is important because earlier spermicidal microbicides like nonoxynol 9, which was an ingredient in a variety of contraceptive products from condoms to contraceptive creams and gels, was eventually found to increase rather than decrease HIV infection rates.

"Nonoxynol 9 was used commonly and was thought to be an extremely safe type of anti-microbial spermicide. But researchers found that it actually increased the rate of HIV infection in women. So now we realize that we must approach new microbicides a little more carefully," Moscicki said.

According to the U.S. Centers for Disease Control and Prevention, women account for more than one quarter of all new HIV/AIDS diagnoses. Women of color are especially affected by HIV infection and AIDS. In 2002, the most recent year for which data are available, HIV infection was the leading cause of death for African American women aged 25 to 34 years. It was the third leading cause of death for African American women aged 35 to 44 years and the fourth leading cause of death for African American women aged 45–54 years and for Hispanic women aged 35 to 44.

In the same year, HIV infection was the fifth leading cause of death among all women aged 35 to 44 and the sixth leading cause of death among all women aged 25 to 34. The only diseases causing more deaths of women were a variety of different types of cancer and heart disease.

Moscicki said that if the gel is approved by the FDA, women would use it about an hour before having intercourse. "If a woman has occasional sex it could be several times a month. If she were a sex worker it could be several times a day," she said.

The study is being conducted in collaboration with the gel’s manufacturer, Starpharma Holdings, Ltd., of Melbourne, Australia, and is being underwritten by the Sexually Transmitted Infection Clinical Trials Group, which is funded in part by NIH and CDC.

Development of the gel has been given fast-track status by the FDA. Fast track status is granted when a drug has the potential to treat a serious or life-threatening condition and demonstrates the potential to address unmet medical needs for that condition.

Source: University of California - San Francisco

Explore further: Certain vaginal bacteria may be linked with increased risk of chlamydia

Related Stories

Certain vaginal bacteria may be linked with increased risk of chlamydia

September 25, 2017
The presence of specific types of vaginal bacteria may be associated with an increased risk for chlamydia infection, finds a small, but well powered study published online in Sexually Transmitted Infections.

Sex diseases in US surge to record high

September 26, 2017
Sexually transmitted diseases surged to a record high in the United States last year, with more than two million cases of chlamydia, gonorrhea and syphilis nationwide, officials said Tuesday.

Low screening rates for adolescents diagnosed with PID in the nation's emergency departments

September 22, 2017
The nation's emergency departments had low rates of complying with recommended HIV and syphilis screening for at-risk adolescents, though larger hospitals were more likely to provide such evidence-based care, according to ...

Rapid hepatitis C testing may help better screen young adults

September 21, 2017
Routine and rapid hepatitis C virus (HCV) testing among young adults who use injection drugs improves life expectancy and may provide a good use of limited resources, according to new research out of Boston Medical Center, ...

Cancer and HIV—closing the screening gap

September 5, 2017
While collaborating with clinical colleagues in rural southwest Georgia, Emory cancer researcher Theresa Gillespie learned a surprising fact. The region has one of the state's largest HIV/AIDS populations outside of metropolitan ...

World lags badly on targets to slash TB, HIV, obesity: study

September 13, 2017
Not a single country, out of nearly 200 reviewed, was on track to meet the UN target of eliminating new tuberculosis infections by 2030, according to a global health review published Wednesday.

Recommended for you

Three-in-one antibody protects monkeys from HIV-like virus

September 20, 2017
A three-pronged antibody made in the laboratory protected monkeys from infection with two strains of SHIV, a monkey form of HIV, better than individual natural antibodies from which the engineered antibody is derived, researchers ...

Fighting HIV on multiple fronts might lead to vaccine

September 20, 2017
A combination antibody strategy could be the key to halting the spread of HIV, according to results from two promising animal studies.

HIV-AIDS: Following your gut

September 18, 2017
Researchers at the University of Montreal Hospital Research Centre (CRCHUM) have discovered a way to slow viral replication in the gastrointestinal tract of people infected by HIV-AIDS.

Study finds cutbacks in foreign aid for HIV treatment would cause great harm

August 30, 2017
Proposed reductions in U.S. foreign aid would have a devastating impact on HIV treatment and prevention programs in countries receiving such aid, an international team of investigators reports. In their paper published online ...

Cancer drug can reactivate HIV

August 24, 2017
People living with HIV must take a combination of three or more different drugs every day for the rest of their lives. Unfortunately, by following this strict treatment plan, they can suffer from side effects ranging from ...

New injectable antiretroviral treatment proved to be as effective as standard oral therapy

August 3, 2017
Intramuscularly administered antiretroviral therapy (ART) may be as effective for HIV treatment as current oral therapies. This is the main conclusion of a Phase II clinical trial carried out by 50 research centers around ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.