May 13, 2013 (SAN DIEGO) – The UC San Diego AntiViral Research Center was recently announced as Benitec Biopharma Limited’s second site for its upcoming phase I/II first-in-man trial for TT-034 in hepatitis C infections (HCV). TT-034 is being developed as a potential “one-shot-cure” for HCV.

A consultant and sub-principal investigator for the study from UC San Diego is Robert Gish, MD, clinical professor of medicine and medical director of Hepatology. Gish is a renowned hepatitis researcher with previous experience using RNAi based therapeutics for HCV. He has over 500 publications in the field and is a fellow of the American College of Physicians and the American Association for the Study of Liver Disease.

“I look forward to working with Benitec and Duke University on this important program,” Gish said. “This is the first time that this therapeutic modality is being tested in humans, and if it is successful I believe it can be a significant step forward, not only for HCV treatment but potentially also as a treatment modality for hepatitis B.”

The principal investigator for the study at UC San Diego is David Wyles, MD, associate professor of medicine at the UC San Diego AntiViral Research Center, the clinical research site that will be conducting the trial. His research interests include the laboratory evaluation of new antiviral therapies for HCV, drug resistance to HCV antivirals, and HCV viral fitness.

Peter French, PhD, chief executive officer of Benitec said, “We are elated that UC San Diego and Dr. Gish will participate in this study. We now have two top clinical research teams working with Benitec on this trial. This constellation of expertise will greatly benefit our HCV program and can help demonstrate the power of our ddRNAi technology in the clinic. Having our two clinical centers in place moves us a step closer to initiating the Phase I/II clinical trial, which we expect to occur during the second half of 2013."

The phase I/II clinical trial is an open-label dose escalation study to evaluate the safety and activity of single doses of TT-034 in patients with chronic HCV genotype 1 infection who have failed previous treatments. The trial is expected to involve 14 patients in 5 sequential dose cohorts. Additional consolidation cohorts may be added during the study to confirm the results of the trial. The primary safety endpoints are dose limiting adverse events. The primary end points are serum viral load reduction and degree of hepatocyte transduction (measured through liver biopsies). There is a pre-specified interim read on safety and activity within months of trial commencement.

January 17, 2013 (SAN DIEGO) - Today, the New England Journal of Medicine published, "Enhanced CD4+ T-Cell Recovery with Earlier HIV-1 Antiretroviral Therapy," suggesting the optimal time for initiating antiretrovial therapy (ART) is within four months after HIV infection.

UC San Diego AntiViral Research Center researchers Susan Little, MD, Douglas Richman, MD, Davey Smith, MD and Jason Young, PhD co-authored the paper that sought to determine the relationship between the timing of the initiation of ART after infection with HIV and the recovery of CD4+ T-cell counts.

HIV researchers and clinicians have long known the overall benefit of starting ART early in the progression of HIV infection. Until now, though, the optimum window period for beginning ART to aid in CD4+ recovery was unknown.

"The thing that we didn't already suspect," Little explained in an interview with KPBS, "is that that restorative time window was so short."

This short restorative time window, has severe implications for HIV testing.

The HIV rapid tests most often used in community health clinics identify HIV antibodies to the virus and may take anywhere from three to six months to be detectable. An HIV infection identified using a rapid test has already progressed at least three months, cutting well into the optimum four-month window for initiating ART.

Fortunately, specialized nucleic acid tests like UCSD's The Early Test detect parts of HIV, instead of the antibodies to the virus. These HIV nucleic acids can be detected in the blood as early as one week after exposure to the virus, drastically improving how soon a new HIV infection can be diagnosed. More importantly, it provides an newly-infected HIV patient the opportunity to begin ART within the optimum four-month window.

Little and her colleagues are optimistic that the findings of their research will encourage HIV testing sites serving communities at high risk for HIV infection to provide nucleic acid testing as a means for early diagnosis and treatment of HIV.

March 3, 2013 (PROVIDENCE, R.I.) – A new multi-site study reveals patients with drug-resistant HIV can safely achieve viral suppression – the primary goal of HIV therapy – without incorporating the traditional class of HIV medications into their treatment regimen. Karen Tashima, MD, director of the HIV Clinical Trials Program at The Miriam Hospital, served as study chair. Richard Haubrich, MD of the UC San Diego AntiViral Research Center served as the study's co-chair.

The AIDS Clinical Trials Group (ACTG) Network’s OPTIONS Trial proves, for the first time, that treatment-experienced patients can leave out this class of medication, known as nucleoside reverse transcriptase inhibitors (NRTI), as part of the regimen. These results could change treatment guidelines, lessen side effects and increase adherence rates, the researchers say.

Tashima and colleagues presented the results from the 48-week study at the annual Conference for Retroviruses and Opportunistic Infections (CROI) in Atlanta on March 6.

“We are so comfortable clinically with the NRTI class that we think we must always use at least one drug from this class in treatment. However, some patients have developed within-class resistance, making the NRTIs less effective overall. Therefore, drugs from this class may not be needed if the new treatment plan contains more effective medications,” said Tashima, who also leads ACTG’s clinical research site at The Miriam Hospital.

“There were a few new drugs coming out at the same time and we decided to turn the question around. Instead of having patients take their current medications from the NRTI class as well as these new drugs from different classes, we asked half of the study participants to add NRTIs and half of them to leave out NRTIs from their new treatment plan. We were able to take the usual study paradigm and turn it around,” she added.

Treatment-experienced patients can develop resistance to therapy due to poor adherence, said Haubrich, a professor of medicine at UC San Diego. Designing a treatment plan using new drugs from new classes and omitting NRTIs leads to fewer pills, and hopefully, better adherence.

“There are several options for treatment naïve patients, but not as many for treatment-experienced. The HIV research field accepted that nucleosides would be an important component for multiple class-experienced patients,” said Haubrich. “However, our results were very clear. We can safely exclude NRTIs, giving physicians a new paradigm for ART prescription in clinic and potentially changing treatment guidelines.”

To ensure eliminating NRTIs from their treatment regimen would not be detrimental for viral suppression, investigators used a web utility to review each of the 413 study participants’ study records to determine optimal treatment plans. This tool allowed all of the study’s investigators to consult together on each study participant, offering the best plan for treatment.
The OPTIONS Trial, also called A5241, included ACTG sites from around the country as well as sites from the International Maternal Pediatric Adolescent AIDS Clinical Trials group and the Adolescent Medicine Trials Network. Study volunteers needed to be at least 16 years old and show treatment experience or resistance to their current HIV medications. Most of the A5241 participants had been on ART for 10 years or more. 

Traditional antiretroviral therapy consists of medications from the nucleoside reverse transcriptase inhibitor class, including tenofovir, azidothymidine and lamivudine. The new medications studied included darunavir and tipranavir from the protease inhibitor class of HIV medications, maraviroc from the CCR5 antagonist class, raltegravir from the integrase inhibitor class, etravirine from the non-nucleoside reverse transcriptase inhibitors class and enfuvirtide an injectable drug from the fusion inhibitor class.

Patients will continue on study for a total of 96 weeks to ensure virologic suppression is maintained.

“There is no question that the results show what we had set out to prove – a treatment-experienced patient will not lose virologic suppression by omitting NRTIs,” said Tashima. “We are so excited to show this data.”

This research was supported by the U.S. Department of Health and Human Services (DHHS), the National Institutes of Health (NIH), the National Institute of Allergy and Infectious Diseases (NIAID) and the Division of AIDS (DAIDS) under awards 5U01AI069472 and UM1-A1068636.

December 13, 2012 (SAN DIEGO) – On December 1, UC San Diego AntiViral Research Center faculty Connie Benson, MD and Susan Little, MD were each honored with the 2012 HIV Community Service Award at the Dr. A. Brad Truax Awards.

The annual recognition, hosted on World AIDS Day, honors the memory of A. Brad Truax, MD, one of the first physicians in San Diego to treat people with AIDS and the first chair of the first advisory board on HIV/AIDS in San Diego County. Through his tireless dedication to prevention and treatment of HIV/AIDS, Truax encouraged people with different interests and agendas to work together to achieve goals for the benefit of the San Diego HIV/AIDS community.

In this spirit, the HIV Community Service Award recognizes exceptional contributions made to HIV efforts by individuals through their outstanding service in HIV education, prevention and/or counseling and testing; HIV care, treatment and/or support services for persons living with HIV/AIDS; and planning, advocacy or policy development, with special recognition to those who provide significant service to the community.

The Truax Awards is sponsored by the HIV Prevention Community Planning Group and the HIV Health Services Planning Council.

November 27, 2012 (SAN DIEGO) – On December 1, Lead the Way offers free, confidential HIV tests to the community in honor of World AIDS Day.

“Part of the World AIDS Day ‘Getting to Zero’ theme is zero new HIV infections,” said Joshua P. Romero, Lead the Way community outreach manager. “The first step in stopping new HIV infections is knowing your status. If you don’t know whether or not you have HIV, you don’t know if you could be transmitting the virus.”

HIV around the World

On December 1 of each year, people from around the world unite to raise awareness about HIV/AIDS and demonstrate international solidarity in the face of the pandemic. The World Health Organization (WHO) established the annual commemoration to spread awareness about the status of the pandemic and encourage progress in HIV/AIDS prevention, treatment and care.

According to WHO, HIV is one of the world's leading infectious killers, claiming more than 25 million lives over the last 30 years. In 2011, there were approximately 34.2 million people living with HIV. Over 60% of people living with HIV are in sub-Saharan Africa.

To help fight HIV transmission in San Diego, Lead the Way is providing free, confidential HIV testing on World AIDS Day.

World AIDS Day Testing Locations

On Saturday, December 1, Lead the Way provides free, confidential HIV testing to the community at the following locations, on a walk-in basis:

Medical Center Pharmacy
3904 Park Boulevard, San Diego, CA 92103
10:00 a.m. – 4:00 p.m.

Lead the Way Storefront
3830 Park Boulevard, San Diego, CA 92103 10:00 p.m. – 4:00 p.m.

November 26, 2012 (SAN DIEGO) – In the U.S., two-thirds of new infections among men who have sex with men are from a primary sex partner. And as many as one in four gay men with HIV do not know they are infected with the virus.

Testing Together, a new couples HIV testing and counseling program based at Emory University and offered at the UC San Diego AntiViral Research Center (AVRC), hopes to bring honesty and openness to sexual relationships within gay couples in an attempt to reduce HIV transmission among gay men.

Testing Together, Healthy Together

Testing Together, funded by the MAC AIDS Fund, provides gay couples with free, confidential HIV testing. Both men in the couple get tested together, get their results together and receive counseling together. The couples also get free movie tickets with soda and popcorn, plus $20.00 for completing a follow-up survey after getting tested.

"We know from our recent research that by testing together and getting results together couples can start an ongoing healthy conversation about HIV and talk openly about building a plan to address sexual health issues in their relationship," said Testing Together project director Patrick Sullivan, PhD, associate professor of epidemiology at Emory, in a news release announcing the program.

In most HIV testing settings, confidentiality issues prevent couples from testing together, much less hearing each other’s HIV test results. With Testing Together, both members of a gay couple sign consents agreeing to get counseling together, test together and hear their test results together.

Specially-trained HIV testing counselors provide a safe space for members of the couple to openly discuss the results of their HIV tests together.

Getting tested together and hearing test results together is just part of the program. The other is the specialized counseling couples receive. Unlike most HIV testing counseling that focuses on past risk behaviors, Testing Together encourages couples to openly discuss their sexual relationships and establish agreements about sex and health.

When do we use condoms? Are we monogamous? What are our rules if we are in an open relationship?

The counseling gives gay couples a dedicated time and place to talk about the details of their sexual health and what they can do to protect each other. And now Testing Together is available in San Diego.

Testing Together in San Diego

The UC San Diego AntiViral Research Center offers Testing Together at two locations in San Diego:

AVRC

220 Dickinson Street, Suite A
San Diego, CA 92103
619-543-8080
https://avrc.ucsd.edu
Monday – Friday, 9:00 a.m. – 4:00 p.m.

Lead the Way

3830 Park Boulevard
San Diego, CA 92103
619-543-9340
http://leadthewaysd.com/
Monday – Friday, 12:00 p.m. – 8:00 p.m.
Saturday, 10:00 a.m. – 4:00 p.m.

Appointments for Testing Together can be made by calling the desired testing location. Couples participating in Testing Together receive free movie passes for participating.

November 7, 2012 (SAN DIEGO) – The UC San Diego AntiViral Research Center (AVRC) welcomes the first man cured of HIV infection to San Diego on Monday, November 12, when it hosts the HIV Cure Conference.

Timothy Ray Brown, founder of the Timothy Ray Brown Foundation at the World AIDS Institute, is the man who anonymously astonished researchers around the world as “The Berlin Patient.” He was the first man to be cured of HIV. This past July, it was announced that two more men cleared HIV from their bodies through a bone marrow transplant similar to Brown’s.

“Words cannot begin to express my joy that two other men may have been cured of HIV,” said Brown in a prepared statement following the July announcement. “We can only hope that [my] case and this development represent the beginning of the end of this plague.”

As part of the HIV Cure Conference, Brown shares his story from diagnoses to cure, providing attendees a first-hand account of what it was like for Brown to be a part of medical history.

“We are excited to have Timothy in San Diego,” said Jeff Taylor, member at large of the AVRC Community Advisory Board (CAB) and the person responsible for Brown’s attendance at the HIV Cure Conference. “The San Diego community can benefit from hearing his story and learning about ongoing HIV research, right here in San Diego, that’s getting us ever closer to a cure.”

Over the past year, a number of research advancements in the treatment, vaccination and cure for HIV have accompanied the news of this first-ever HIV cure.

At HIV Cure Conference, Brown joins HIV researchers from UC San Diego and The Scripps Research Institute for updates on HIV research. These world-renowned scholars will provide the community with updates on HIV treatment, cure and vaccine research.

Davey Smith, MD of the AVRC is the 2010 HIV Medical Association Researcher of the Year and the first to identify HIV superinfections in San Diego. He will discuss advancements in HIV treatment and prevention research, including the FDS’s recent approval of pre-exposure prohylaxis for HIV treatment. William Schief, PhD, an associate professor of immunology at The Scripps Research Institute, will give an update on the progress toward an HIV vaccine. The research presentations conclude with Doug Richman, MD, director of the Center for AIDS Research at UCSD. Richman is credited with discovering HIV resistance to antiviral medications and will update attendees on advancements in HIV cure research.

“We are very fortunate to live where we do,” said Andy Kaytes, a community member and CAB co-chair. “We have access to some of the best and brightest minds in HIV research and care, and it’s important that the community knows that and takes advantage of these resources.”

Conference Supporters

The HIV Cure Conference is made possible through the generous support of the following: AIDS Healthcare Foundation, AIDS Research Institute, AntiViral Research Center, Genentech, Modern HEALTH Pharmacy, The San Diego LGBT Community Center, UC San Diego Health Sciences International, and ViiV Healthcare.

(SAN DIEGO) October 2, 2012 – On Thursday, October 4 the UC San Diego AntiViral Research Center (AVRC) hosts a focus group to learn more about the community’s thoughts on pre-exposure prophylactic (PrEP). Recently, PrEp was approved by the FDA as a preventative medication for HIVinfection. Researchers are interested in learning what men who have sex with men think about taking one pill per day in order to prevent HIV infection.

Researchers are also interested in learning what tools might be helpful in reminding people to take PrEP. One tool to help remind people to take PreP is text messaging. Researchers want to hear opinions from people who can advise them about a text messaging system designed to help people take PrEP when prescribed.

PrEP Focus Group
In order to conduct this focus group, the AVRC is seeking:
•    HIV-uninfected persons who are interested in PrEP, and
•    HIV-infected persons who are willing to share his or her experience in taking anti-HIV medications.

Focus group participants should be willing to speak up in a group setting and interact with others in the discussion of the topic. Those who agree to join the focus group will be in a room with a group facilitator, co-facilitator and seven to twelve other participants. Please note that HIV-infected and HIV-uninfected persons will be participating in the same focus group, so participants should be comfortable sharing their HIV-status, and be willing to keep status information confidential outside of the focus group.

The focus group facilitator will introduce a number of questions and facilitate the discussion. The group will last one to two hours and will be audiotaped and transcribed to ensure that all of the information covered in the discussion is collected. This audiotape will be used for program development and scientific research. All participants will be asked to sign a separate audiotape consent document. If participants do not wish to be audiotaped, they should not participate in this focus group.

Focus Group Participant Compensation
Participants will be compensated $15 for the time they are involved in the focus group. Food will also be served.

Time and Location of Focus Group
The Focus Group is scheduled for Thursday, October 4, from 6:00 p.m. until 7:30 p.m. at the HNRP (220 Dickinson Street, Suite B). Free parking is available in Lot P957. Please ask the receptionist at the HNRP for a parking pass.

Signing Up to Participate
If you are interested in participating in the focus group, please email alertstudy@ucsd.edu or call 619-543-5011.

Read the full story, "UC San Diego Researcher Receives $2.5 million Award from the National Institute on Drug Abuse," in the UC San Diego Health System Newsroom

Read the full story, "HIV Prevention in a Pill," in the UC San Diego News Center

SAN DIEGO (June 25, 2012) – One in five people living with HIV do not know they are infected. To help reverse that trend, Lead the Way is offering free, confidential HIV tests on National HIV Testing Day.

On Wednesday, June 27, Lead the Way will be providing free, confidential HIV tests from 9:00am to 3:00pm at MOMS Pharmacy (3940 Fourth Ave, San Diego, CA 92103) and from noon to 8:00pm at Lead the Way (3830 Park Blvd, San Diego, CA 92103). Anyone who tests at either location will also receive a free Lead the Way t-shirt.

“We hope that San Diegans understand that getting tested is an important opportunity to support the overall health of their community,” said Susan Little, MD, professor of medicine in UC San Diego’s Division of Infectious Diseases and head researcher of Lead the Way. “The ultimate goal is that everyone gets tested and those who need treatment receive it, so we can significantly curb the spread of HIV.”

ABOUT NATIONAL HIV TESTING DAY

National HIV Testing Day (NHTD), June 27, was established by the National Association of People with AIDS in 1995. It is an annual observance to promote and increase HIV testing around the U.S., so that more Americans know their status.

ABOUT LEAD THE WAY

Lead the Way is the nation’s first comprehensive test and treat model for HIV prevention and is a research program of the UC San Diego AntiViral Research Center. The study aims to find out whether or not people will test for HIV if the test is made readily available in the 92103 and 92104 zip codes of San Diego. Testing 10,000 adults in the two communities is the first step in a multiple-year project to demonstrate that, with appropriate testing and HIV treatment, HIV can be controlled within a community.

Since Lead the Way began in May 2011, over 1,300 people have participated in the study. To date, UCSD has identified more than twice the number of new HIV infections per year than it did in the year preceding the launch of Lead the Way.

To learn more about Lead the Way, visit www.leadthewaySD.com or call (619) 543-9340.