14 DAY TRIAL // Could this gel be the so-much-looked-after weapon enabling women to prevent a HIV infection? Trials made by a team from the University of Alabama at Birmingham (UAB) and the University of Pittsburgh School of Medicine seem to indicate so. Tenofovir was self-applied by patients and well tolerated by HIV negative women.
"The gel is safe to use, and well tolerated by HIV-negative women. This sets the stage for larger studies to see if tenofovir can prevent HIV infection," said Dr. Craig Hoesley, associate professor in the UAB Division of Infectious Diseases and co-author on the initial Phase II trial, whose results have been presented Monday, Feb. 25, at the international microbicides meeting in New Delhi, India.
"Based on what we have learned we can proceed with greater confidence on a path that will answer whether tenofovir gel and other gels with HIV-specific compounds will be able to prevent sexual transmission of HIV in women when other approaches have failed to do so," said lead researcher Dr. Sharon L. Hillier, director of reproductive infectious disease research at the University of Pittsburgh School of Medicine.
During the 6-month trial, the 200 female subjects were instructed to use the gel daily or before each intercourse. They were also asked to use condoms besides the gel. Tenofovir was found to cause no secondary effects in liver, blood or kidney. All subjects were aged 19 to 50, sexually active, HIV-negative women and enrolled at UAB, Bronx-Lebanon Hospital Center in New York and the National AIDS Research Institute in Pune, India. 64% of the women were married. 80% of the subjects instructed to apply the gel two hours before intercourse did so; 83% said to apply the gel daily followed the instructions.
"If the gel were approved to help prevent HIV infection, more than 90% of the study volunteers said they would seriously consider using it, regardless of the regimen, to protect their sexual health. We asked women 'How acceptable is this as a prevention option, is it too messy, is it a nuisance, and will you use it?' Our study showed they will use it and they're not bothered by the gel," said Hoesley.
Tenofovir employs a type of anti-retroviral chemicals (nucleotide reverse transcriptase inhibitors) that impede the HIV ability to multiply.