Claim: Tests of New AIDS Gel Show Promise for Women.
Verdict: SUPPORTS

Retrieved passages:
title: CAPRISA 004
text: young women who were judged to be at risk of contracting HIV volunteered to use a study gel in their vaginas, with half of those receiving the microbicide gel and the other half getting the placebo (according to their randomization results). The study asked participants to apply a first dose of the gel within 12 hours before having sex and to apply another dose within 12 hours after sex. All study volunteers participated in HIV risk reduction counseling and received condoms. The study assisted in arranging treatment for any sexually transmitted infections that participants contracted. The study began in May

title: HIV/AIDS in Africa
text: tested and found effective a tenofivir-based anti-retroviral vaginal gel that could be used as pre-exposure prophylaxis. Testing of this gel was conducted at the University of KwaZulu-Natal in Durban, South Africa. The South African government has indicated its willingness to make it widely available. The FDA in the US is in the process of reviewing the drug for approval for US use. The AIDS/HIV epidemic has led to the rise in unethical medical experimentation in Africa. Since the epidemic is widespread, African governments sometimes relax their laws in order to get research conducted in their countries which they would otherwise

title: Microbicides for sexually transmitted diseases
text: at preventing HIV transmission from men to women during sex. In July 2010 the Centre for the AIDS Programme of Research in South Africa (CAPRISA) released results of a study establishing proof of concept that an ARV-based, topical microbicide can reduce the likelihood of HIV transmission. The trial, CAPRISA 004, was conducted among 889 women to evaluate the ability of 1% tenofovir gel to prevent male-to-female HIV transmission. The study found a 39% lower HIV infection rate in women using 1% tenofovir gel compared with women using a placebo gel. In addition, tenofovir gel was shown to be safe as

title: Rectal microbicide
text: same vaginal formulation of tenofovir gel that reduced HIV acquisition by an estimated 39 percent overall in the CAPRISA (Centre for the AIDS Programme of Research) 004 trial that was conducted in South Africa. In September 2009, 18 men and women began enrolling in the trial, which was sponsored by the Microbicide Trials Network (MTN) and UCLA’s Microbicide Development Program. The study tested the safety and acceptability of single- and multiple-day rectal applications of tenofovir, a single oral dose of tenofovir, and a placebo. Laboratory tests showed that HIV was significantly inhibited in rectal tissue samples from participants who applied

title: CONRAD (organization)
text: in a 24-hour period - also called the BAT 24 regimen. In the overall study population, tenofovir gel reduced HIV-1 incidence by 39% and herpes simplex virus-2 (HSV-2) infections by 51%. CAPRISA 004. Two subsequent trials tested the gel in larger populations in order to provide more evidence for regulatory approval: VOICE, sponsored by the MTN, studied daily use of the gel, and FACTS 001, sponsored by CONRAD and conducted by the Wits Reproductive Health and HIV Institute in South Africa, replicated the CAPRISA 004 study in a larger population of women and called for the BAT24 regimen. Unfortunately, neither

title: Microbicides for sexually transmitted diseases
text: tested. The results of the CAPRISA 004 trial provide statistically significant evidence that ARVs, topically applied to the vaginal mucosa, can offer protection against HIV and (potentially) other pathogens. During the study, 38 of the women who used the tenofovir gel acquired HIV and 60 women who used a placebo gel became HIV-infected. No tenofovir-resistant virus was detected in the women who acquired HIV infection during the study. In addition to demonstrating efficacy against HIV, CAPRISA 004 found evidence that tenofovir gel also prevents the transmission of herpes simplex virus type 2 (HSV-2). HSV-2 is a lifelong, incurable infection which

title: HIV/AIDS
text: vaginal gel containing tenofovir (a reverse transcriptase inhibitor) immediately before sex seems to reduce infection rates by approximately 40% among African women. By contrast, use of the spermicide nonoxynol-9 may increase the risk of transmission due to its tendency to cause vaginal and rectal irritation. Circumcision in Sub-Saharan Africa "reduces the acquisition of HIV by heterosexual men by between 38% and 66% over 24 months". Due to these studies, both the World Health Organization and UNAIDS recommended male circumcision in 2007 as a method of preventing female-to-male HIV transmission in areas with high rates of HIV. However, whether it protects

title: Rectal microbicide
text: University of California, Los Angeles (UCLA's) Microbicide Development Program initiated the first Phase I RM safety trial, investing the safety and acceptability of UC-781, in December 2006. Rectal application of UC-781 gel, a potent antiretroviral (ARV) drug, was shown to be safe and acceptable to the 36 men and women in the trial. Phase I trials normally focus solely on safety and acceptability, but researchers used a novel approach in this trial: taking rectal tissue biopsies from participants and exposing them to HIV ex vivo in the laboratory. The drug significantly reduced HIV transmission in these essays. RMP-02/MTN-006 Tested the

title: CONRAD (organization)
text: U.S. Agency for International Development (USAID), with additional funding from The Bill & Melinda Gates Foundation and the National Institutes of Health (NIH). CONRAD works by conducting pre-clinical development and clinical trials. MICROBICIDES and HIV PREVENTION: Using the antiretroviral tenofovir (TFV), donated by Gilead Sciences, CONRAD developed a gel for use in the genital tract. Tenofovir gel was tested in a double-blinded, placebo-controlled Phase II study conducted by the Centre for AIDS Research Programme in South Africa (CAPRISA). Study participants were required to insert their assigned gel before and after sex, using a pre-filled applicator, not to exceed two doses

title: Microbicides for sexually transmitted diseases
text: Agency. Results released in February 2009 from a clinical trial of PRO 2000 (Indevus Pharmaceuticals), a vaginal-microbicide gel (0.5%), sparked hope that it might provide modest protection against HIV. The results of a larger trial released in December 2009 showed that PRO 2000 was safe as administered, but was ineffective in reducing the risk of HIV infection. That trial (MDP 301) was sponsored by the Microbicides Development Programme. MDP 301 was conducted in South Africa, Tanzania, Uganda and Zambia with more than 9,300 women volunteers. No significant difference was found in the number of women who contracted HIV in the

title: CAPRISA 004
text: in reducing risk of contracting HIV during sex and 51% effective in preventing genital herpes infections. The results of CAPRISA 004 were formally released at the 18th International AIDS Conference. Michel Sidibé of UNAIDS described the results of the study as being very encouraging because the treatment "can be controlled by women, and put in 12 hours earlier, and that is empowering. They do not have to ask the man for permission to use it. And the cost of the gel is not high." Anthony Fauci of NIAID stated that "This is the first study that has shown a clear-cut

title: Microbicides for sexually transmitted diseases
text: need to be confirmed by other clinical trials before the microbicide tenofovir gel is made available to the public. This decision rests with regulators, particularly in South Africa. In 2013, the VOICE study (MTN 003), another large-scale trial, is scheduled to release results. VOICE is evaluating three different strategies to prevent HIV in women: one ARV-based microbicide and two regimens consisting of oral ARVs on a daily basis. The VOICE trial is testing 1% tenofovir vaginal gel in a once-daily formulation. It is not known at this time if VOICE will be considered a confirmatory trial for CAPRISA 004, which

title: Microbicides for sexually transmitted diseases
text: films. The results of the first efficacy trial of an ARV-based microbicide, CAPRISA 004, tested 1% tenofovir in gel form to prevent male-to-female HIV transmission. The trial showed that the gel (which was applied topically to the vagina), was 39% effective at preventing HIV transmission. CAPRISA 004 was the 12th microbicide-efficacy study to be completed, and the first to demonstrate a significant reduction in HIV transmission. The results of this trial are statistically significant and offer proof of concept that ARVs, topically applied to the vaginal mucosa, can offer protection against HIV (and other) pathogens. Most of the first generation

title: HIV/AIDS research
text: A microbicide for sexually transmitted diseases is a gel which would be applied to the skin - perhaps a rectal microbicide for persons who engage in anal sex or a vaginal microbicide for persons who engage in vaginal sex - and if infected body fluid such as blood or semen were to touch the gel, then HIV in that fluid would be destroyed and the people having sex would be less likely to spread infection between themselves. On March 7, 2013, the Washington University in St. Louis website published a report by Julia Evangelou Strait, in which it was reported

title: National Institute of Allergy and Infectious Diseases
text: compared with a similar course of AZT. Subsequent clinical trials, including some funded by NIAID, showed that AIDS drugs also can reduce the risk of MTCT through breast milk. These and other studies have led to World Health Organization recommendations that can help prevent MTCT while allowing women in resource-limited settings to breastfeed their infants safely. More recently, NIAID-funded scientists found that testing at-risk infants for HIV and then giving ART immediately to those who test positive dramatically reduces rates of illness and death. HIV-infected infants were four times less likely to die if given ART immediately after they were

title: HIV and men who have sex with men
text: Home testing is considered especially important because 8%-39% of partners tested in studies of partner counseling and referral services (PCRS) were found to have a previously undiagnosed HIV infection that their partner was unaware of. In October 2012, OraQuick, the first rapid HIV home-testing kit, went on sale for $40. The test is nearly 100% accurate when it predicts HIV-negative results for HIV-negative individuals. However, for HIV-positive individuals that are not yet producing the antibodies detected by the test, it produces a false negative 93% of the time. Although the manufacturer, OraSure Technologies, is not advertising the test for use

title: Microbicides for sexually transmitted diseases
text: of rectal microbicides with homosexual men ages 18 to 30 years old. Ultimately, successful topical microbicides might simultaneously employ multiple modes of action. In fact, long-acting formulations such as vaginal rings could provide the technology needed to deliver multiple active ingredients with different mechanisms of action. A major breakthrough in microbicide research, announced in July 2010, reported that an ARV-based microbicide gel could partially prevent HIV. A trial led by the Centre for the AIDS Programme of Research in South Africa (CAPRISA), conducted in South Africa, demonstrated that the ARV tenofovir, when used in a vaginal gel, was 39% effective

title: CONRAD (organization)
text: prophylaxis (PrEP) trials which tested daily use of an oral antiretroviral in women and several vaginal gel trials for HIV prevention have been challenged by poor adherence. There is a clear need for cost-saving and efficient trial designs to test safety and efficacy. CONRAD, AVAC and the Forum for Collaborative HIV Research joined forces to convene a workshop in June 2014 to explore the potential of alternative trial designs for microbicides that can help address the issue of poor adherence. CONRAD (organization) CONRAD (Contraception Research and Development) is a non-profit organization scientific research organization that works to improve the reproductive

title: Microbicides for sexually transmitted diseases
text: blocking transmission of both HIV and genital herpes in macaque monkeys. It has passed the animal-testing phases of the drug-approval process in Australia and the United States, which will be followed by initial human safety tests. The National Institutes of Health and the National Institute of Allergy and Infectious Diseases have awarded grants totaling $25.7 million for VivaGel's development and testing. VivaGel is being developed as a standalone microbicide gel and an intra-vaginal microbicide. It is also being evaluated for use in condoms. It is hoped that VivaGel will provide an extra resource to mitigate the sub-Saharan AIDS pandemic. It

title: Helen Rees
text: SA microbicide network trial (FACTS 001), a Phase 3 trial of 1% tenofovir gel for HIV prevention, is a lead researcher on a newly initiated pan African study on HIV acquisition and contraception (ECHO), and is the Co-principal investigator in a study evaluating the feasibility of using ARVS for HIV prevention as pre-exposure prophylaxis and early treatment for female sex workers. She is currently leading the development of Wits University's Flagship Centre for Vaccinology together with Professor Shabir Madhi (RMPRU) and other senior Wits University Scientists. Rees serves on numerous scientific committees and boards, including for WHO, UNAIDS, NIH, IAVI,