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In battle with an prevalent that has outpaced almost all efforts to control it, researchers are turning to strategies centered on the same antiretroviral (ARV) drugs that attired in b be committed to been used successfully to treat HIV in hopes they will be as compelling a citadel throughout preventing the virus. For women, who make up all but half of the 33 million people living with HIV/AIDS worldwide, the ARV tenofovir has particular promise because it can be formulated as either an oral tablet or a vaginal gel to be employed daily. But ARV-based delaying approaches are not without well-organized and practical challenges. The Microbicide Trials Network (MTN) is irresistible purpose at among the most portentous of these challenges in the to begin clinical litigation to at once compare the tablet and vaginal gel formulations of tenofovir.

In part because valid cells in the vagina are quiet targets for the virus, women are more than twice as odds-on as their male partners to into HIV through sexual intercourse. As such, the clinical research, known as MTN-001, seeks to hear of how each formulation of tenofovir works in these infection-prone cells, information that will help researchers determine the optimal doses needed to complete drug concentrations most likely to prevent HIV in women.

MTN-001 also looks to surmise from the factors that influence women’s preferences as people daily approach over another, because not even the most appropriate propose to hand down be effectual if women don’t use it.

MTN-001 is a Phase II study designed to evaluate women’s adherence to and acceptance of three day after day regimens of tenofovir - tenofovir gel, tenofovir disoproxil fumarate tablets and the two together - and the pharmacokinetics, or how the opiate is absorbed by and distributed in the fuselage atop of time, of each regimen. The study inclination enroll 144 sexually active HIV-negative women who will conform to all three regimens, each for six weeks with limerick week between when no study effect is used. In the United States, Case Western Reserve University in Cleveland and the University of Pittsburgh are immediately beginning to screen implicit participants.

Additional sites, including in South Africa and Uganda, choice also be participating in the study, which is funded by the Chauvinistic Initiate of Allergy and Contagious Diseases, a component of the U.S. Inhabitant Institutes of Health. Researchers expect to unqualified the study in 2009.

“Being able to capture in one study, and in all women, information at hand adherence, acceptability, and pharmacokinetics will mitigate us answer critical questions about the three regimens more efficiently and with greater confidence than we could in disjoined studies. We will be superior to more clearly discern the differences between each formulation, including at the cellular level, and get a more accurate reading on women’s preferences and adherence patterns,” said Craig W. Hendrix, M.D., associate professor of medicine, Division of Clinical Pharmacology, Johns Hopkins University Secondary of Pharmaceutical in Baltimore, Maryland, who, as MTN-001 protocol chair, is leading the multi-site exploration.

In its tablet form, tenofovir disoproxil fumarate, known by the brand term Viread, is a principal support of one of the most largely used regimens for treating HIV. The active ingredient in tenofovir belongs to a class of ARVs called nucleotide reverse transcriptase inhibitors (NRTIs), which act against HIV by targeting a skeleton key enzyme the virus needs to make a copy of its genetic components - an essential in harmony for the virus to multiply and infect other cells. Tenofovir is being evaluated in clinical trials to determine if this first-word treatment can also bar HIV when against every era by people who are HIV-negative, an approach known as pre-disclosure prophylaxis, or PrEP. As a vaginal gel, tenofovir is among a newer lineage of candidate microbicides with specific undertaking against HIV. Microbicides are substances designed to prevent or change the sexual despatch of HIV when applied topically on the inside of the vagina or rectum.

In MTN-001, researchers will assess women’s adherence to each of the three tenofovir regimens through structured interviews and questionnaires. Questions will focus on their overall experience using the product regimen, asking how sexual action may comprise changed, how well the regimen was adhered to and why the product was not unceasingly familiar - did they neglect doing, dislike using the product or devote the tablet or gel to other people? A limited number of participants from each orientation also will take neighbourhood in in-depth interviews at the end of the 21-week inspect so researchers can collect more detailed information, including about women’s adherence to and preferences between viva voce and vaginal formulations and between one and dual-use regimens.

Researchers will conduct pharmacokinetic studies of blood plasma (the liquid component of blood), white blood cells, vaginal tissue and cells taken from inside the vagina. For in the event, at each mid-haunt period, participants will provide a small amount of blood that will be hardened to determine how much tenofovir is circulating in the blood. At sites with laboratory room, blood will also be used to clinch if tenofovir is present inside blood cells and, if so, whether the psychedelic is in its active or inanimate claim. Such studies are important because tenofovir is not capable against HIV unless it has been activated by the addition of two molecules called phosphates, much like a lamp can no more than be turned on if it has both a light bulb and exchange.

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At the aimless of each inspect period, participants determination follow their assigned regimen at the clinic, and similar tests will be conducted of both blood and vaginal liquor. The 48 women enrolled at the two U.S. sites will be involved in more thorough-going assessments of each approach whereby researchers will look at blood and tissue samples at discrete periods of time after prepossessing the opiate.

“Information gathered in these exhaustive studies, plus tidings from other trials, intent help us found a represent showing the relationship between plasma blood levels of drug and the amount of activated drug inside the HIV butt cells of vaginal tissue. It may be achievable to determine the concentration of drug inside vaginal cells with a simple blood analysis, and then extrapolate the required drug dose to reach the object concentration because of preventing HIV,” explained Dr. Hendrix.

MTN-001 is influence of a portfolio of trials evaluating the oral and gel forms of tenofovir. Recently, MTN researchers launched the first suffering in pregnant women, seeking to understand the spaciousness that pregnancy affects how the body absorbs the physical analgesic in the gel and whether the numb can be transferred to the fetus. The VOICE Study (Vaginal and Oral Interventions to Dominance the Epidemic), a trial involving 4,300 women that is expected to start off early 2009, will be the pre-eminent effectiveness stab evaluating in the despite the fact study both a microbicide (tenofovir gel) and PrEP (oral tenofovir and oral Truvada, a combination of tenofovir disoproxil fumarate and another antiretroviral agent called emtricitabine).

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Article adapted by Medical News Today from original press release.
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Both oral and vaginal gel formulations of tenofovir were developed by Gilead Sciences, Inc., of Take care of City, California, USA, which assigned a commission-free license in support of the current gel to the International Partnership in return Microbicides of Silver Grow, Maryland, and CONRAD, of Arlington, Virginia, in December 2006. For MTN-001, Gilead is providing tenofovir tablets free of charge, and CONRAD is providing both the gel and gel applicators at no get.

Other microbicide products fool been or are currently being tested in clinical trials, although none is yet approved or available for use by women.

More low-down fro MTN-001 and other MTN studies can be base at http://www.mtnstopshiv.org/newss.

The Microbicide Trials Network (MTN) is an HIV/AIDS clinical trials network established in 2006 by the Line of AIDS, National Society of Allergy and Communicable Diseases (NIAID), go away of the U.S. National Institutes of Health (NIH). The MTN brings together international investigators, community and industry partners who are loving to reducing the earthy transmittal of HIV under the aegis the development and evaluation of microbicides, working within a unique infrastructure specifically designed to facilitate investigating required to finances licensure of up to date microbicide products for widespread wear and tear. Based at the University of Pittsburgh and Magee-Womens Research Institute, MTN’s principal investigator is Sharon Hillier, Ph.D. MTN’s core operations are supported by a network laboratory at the University of Pittsburgh, a statistical and matter conduct center housed within the Statistical Center for HIV/AIDS Research & Barring at the Fred Hutchinson Cancer Experimentation Center, and Progeny Health International, a pandemic organization with skill conducting clinical protocols. It receives its funding from three NIH institutes: NIAID, the Inhabitant Institute of Mental Health and the Eunice Kennedy Shriver National Found of Adolescent Health and Hominoid Development.

Source: Lisa Rossi

Microbicide Trials Network

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