Reaching for a Cure: HIV and AIDS
Anti-HIV Microbicide Gel Has Potential to Prevent HIV Transmission in Women
 If HIV cannot replicate, the authors infer, it is unlikely that it will be able to survive in the body long enough to cause infection. Prior research shows that tenofovir, when applied as a vaginal gel in monkeys, can block the transmission of Simian Immunodeficiency Virus (SIV), an animal virus that is very similar to HIV.
Approximately 5 million people will be infected with HIV this year—almost half of them women. Because the majority of new HIV infections occur via heterosexual intercourse, there is a need for new ways to prevent the sexual transmission of HIV. Although condoms can offer protection from HIV, in many societies women’s legal and social status is subordinate to men’s and they may not be able to negotiate their effective use, the paper states.
“A safe and effective topical microbicide would offer women an HIV prevention method that they could control,” Mayer says.
In addition, researchers evaluated a subgroup of women in the study to determine if the active ingredient in tenofovir gel was absorbed into their bloodstream. Approximately half of these women had low tenofovir levels in their plasma at one or more times during the 14-day study. Further evaluation is needed to determine if absorption of tenofovir into the bloodstream could be beneficial in enhancing the gel’s effectiveness or could cause adverse long-term side effects.
The study participants included 84 women, 18 to 45 years of age. Of those, 60 were not infected with HIV and 24 were HIV-infected women. All participants used the study product for 14 consecutive days and received frequent safety assessments and pelvic exams during the study at one of four research sites: The Miriam Hospital in Providence, RI; Hospital of the University of Pennsylvania in Philadelphia; Harlem Hospital and Bronx-Lebanon Hospital Center, both in New York.
The most common adverse effects reported by women were mild in nature, mainly itching and increased vaginal discharge. None of the participants experienced significant changes in laboratory tests while using the gel.
Past safety trials of microbicides showed that certain gels caused ulcerations and inflammation in women that could actually facilitate HIV transmission. The favorable findings of the tenofovir gel’s phase I safety and acceptability trial has already led to a larger phase II safety study in at-risk women due to begin in the spring of 2006.
According to the study, there was a high acceptability rate among participants, as 94 percent of women said they would definitely or probably use the gel if it were available and they wanted protection from HIV transmission.
The Miriam Hospital participates in the HPTN as part of a clinical trial unit coordinated by Fenway Community Health in Boston. The study was also conducted in conjunction with clinical investigators from Women & Infants’ Hospital in Providence, RI.
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