Navigation Links
Early trial suggests rectal microbicide is safe, could significantly reduce HIV transmission
Date:11/8/2011

A topically applied microbicide gel containing a potent anti-HIV drug has been found to significantly reduce infection when applied to rectal tissue that was subsequently exposed to HIV in the laboratory, according to a new study by the UCLA AIDS Institute. The gel was also found to be safe and acceptable to users.

The first-ever phase 1 clinical trial of the rectal HIV-prevention drug known as UC781, a non-nucleoside reverse transcriptase inhibitor, is described in the current edition of the online journal PLoS ONE.

The trial represents the first use of this novel approach to obtain early insights into the drug's potential to prevent real-life infections during sexual exposure. In addition, it represents an important contribution to efforts aimed at strategically preventing HIV transmission during receptive anal intercourse.

While anal-receptive intercourse is known to be the main route for new HIV infections in men who have sex with men, far more women than men worldwide practice anal intercourse. The risk of HIV infection, per sex act, is anywhere from 20 to 2,000 times greater with receptive anal sex than receptive vaginal sex particularly if there are other infections present, such as herpes, gonorrhea or chlamydia, according to the study's lead author, Dr. Peter Anton, a professor of medicine in the division of digestive diseases at the David Geffen School of Medicine at UCLA.

The significant reduction in the ability of HIV to infect tissues treated with the drug was surprising, Anton said, as this was a new index in clinical trials. Typically, phase 1 clinical trials focus primarily on safety.

"While the main goal of this trial was also to evaluate safety, these new tests enabled us to evaluate, indirectly, whether this drug and route of delivery might potentially reduce new HIV infections," said Anton, who is also a member of the UCLA AIDS Institute. "Of course, it is very gratifying that the results were so impressive. This approach reflects the kind of intensive analyses these dedicated participants in these early trials are willing to tolerate to help us evaluate a drug's potential earlier in the pipeline of drug development."

Anton also noted that although this is the first time this infectibility analysis has been used in a human clinical trial, the results were quite significant.

Until now, microbicide clinical trials have focused on vaginal transmission. These trials, fortunately, have had successful results in the past year, after nearly a decade of disappointment. But the development of a microbicide prevention gel for rectal application has only been under way for the past five to six years.

In the current trial, researchers tested a formulation of the gel that was created for vaginal use in human trials and that contained two concentrations of UC781. They enrolled 36 male and female subjects at UCLA who were not infected with HIV, and they collected blood and rectal tissue samples at baseline, before participants were randomized to either a placebo group or to receive one of two concentrations of UC781. All participants were given the placebo or active drug as a single exposure by the team's clinicians, with research samples collected 30 minutes later for analysis.

After two to three weeks, the participants resumed the second part of the trial by applying the gel or placebo once daily over seven days on their own at home. Afterwards, they returned to the clinic for another collection of samples. All participants completed the study once they were enrolled. In-depth interviews with each participant assessed their acceptability of the current form of the product.

Though the microbicide used for this study was formulated for vaginal use, the same team of researchers has also developed a rectal-specific microbicide gel, which they plan to start testing in a clinical trial in January 2012.


'/>"/>
Contact: Enrique Rivero
erivero@mednet.ucla.edu
310-794-2273
University of California - Los Angeles Health Sciences
Source:Eurekalert

Related medicine news :

1. Minnesota Department of Health Report: Nearly 6,000 Hospitalizations for COPD in 2007
2. Moms Lifestyle in Early Pregnancy Affects Babys Size
3. Early life stress may predict cardiovascular disease
4. MDS Announces Agreements to Divest MDS Pharma Services Early Stage Business
5. Alzheimers Association Applauds Social Security Administration for Adding Early-Onset Alzheimers to Its Compassionate Allowances Initiative
6. Alzheimers Foundation of America Applauds Social Security for Speeding Disability Benefits for Early-Onset Alzheimers Disease
7. JCI online early table of contents: Feb. 15, 2010
8. 29 Clear Channel stations Nationwide Raise Nearly $2.8 Million to Help Save the Lives of Kids Fighting Cancer and Other Deadly Diseases
9. Researchers find biomarkers in saliva for detection of early-stage pancreatic cancer
10. Early On, Hormone Therapy May Raise Womens Heart Risks
11. FriendsofWater.com Responds to the National Acadamy of Sciences Report that Millions of Americans Get Sick Yearly from Contaminated Water
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/19/2017)... , ... January 19, 2017 ... ... member of the American Osteopathic College of Proctology) announced today the opening ... throughout Southern California ( http://www.hemorrhoidsremovalcenterscalifornia.com ): Hemorrhoids Center of Los Angeles (Beverly ...
(Date:1/18/2017)... ... 2017 , ... A recent video posting of a new fidget product gathered ... fidgeting to relieve stress and anxiety. No one was more surprised than Think ... just completed a successful Kickstarter campaign raising $67,000 on the popular crowdfunding platform. ...
(Date:1/18/2017)... Virginia (PRWEB) , ... January 18, 2017 , ... From ... studies are released almost daily linking gut health to chronic disease, mental health and ... New Year ” as an important resolution to consider. , For one Charlottesville restaurant, ...
(Date:1/18/2017)... ... January 18, 2017 , ... ... Department of Bioengineering are collaborating on a research project focused on multiple sclerosis ... project seeks to use nanotechnology to control the disease without compromising normal immune ...
(Date:1/18/2017)... Cranbury, NJ (PRWEB) , ... ... ... Times®, the specialty pharmacy industry’s leading journal and most-read publication among specialty ... Vanderbilt University Medical Center through its Strategic Alliance Partnership (SAP) program, announced ...
Breaking Medicine News(10 mins):
(Date:1/19/2017)... Jan. 18, 2017 The Academy of ... Drug Administration (FDA) for its release today of ... health decision makers can proactively share clinical and ... well as emerging therapies awaiting FDA approval. ... recommendations that AMCP developed during two multi-stakeholder meetings ...
(Date:1/18/2017)... Jan. 18, 2017  EnteroMedics Inc. (NASDAQ: ... using neuroblocking technology to treat obesity, metabolic diseases ... of an underwritten public offering of units for ... underwriting discounts and commissions and offering expenses payable ... of Class A Units, priced at a public ...
(Date:1/18/2017)... India , January 18, 2017 ... Imaging Technologies Market by Type: Global Opportunity Analysis and Industry ... size was valued at $2,544 million in 2015 and is ... CAGR of 8.4% from 2016 to 2022. North ... accounted for over three-fourths market share in 2015. Ionizing breast ...
Breaking Medicine Technology: