Researchers at the University of Pittsburgh will commence a clinical trialA clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. on a vaginal microbicide in pregnant women. Sixteen HIV-negative women, scheduled for caesarean delivery at the University’s Women’s Hospital, will be enrolledThe act of signing up participants into a study. Generally this process involves evaluating a participant with respect to the eligibility criteria of the study and going through the informed consent process. in coming months and given a single dose of tenofovir topical gel applied inside the vagina two hours before giving birth. Researchers hope to understand the extent that pregnancy affects how the body absorbs the active drug in the gel and whether the drug can be transferred to the foetus.
Tenofovir is an effective drug used to treat HIV and researchers wish to know if it could work as a microbicide in the future. The risk of participants in a microbicide trial becoming pregnant has always been of concern to researchers even though trial protocols require the use of contraception. Indeed pregnancy has occurred in 5- 10% of participants. Because the risks to the women and their babies are unknown, they are told to stop using the product immediately.
With this trial researchers hope to learn more about the use and safety of microbicides during pregnancy. Using information from other trials where women have become pregnant while on either a microbicide or an oral antiretroviralA medication or other substance which is active against retroviruses such as HIV. drug they are also looking to discover whether using these during pregnancy — a time when women are at even greater risk of acquiring HIV through sexual intercourse — could prevent mother-to-child transmission and if there are any effects on foetal and/or neonatal development.
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