University of California to Conduct Largest PrEP Demonstration Project in U.S.

The California HIV/AIDS Research Program (CHRP) of the University of California recently announced that it would participate in the largest HIV prevention pill test in the United States, The Los Angeles Times reports. The CHRP will divide $11.8 million to medical groups including three UC campuses—UC Los Angeles, UC San Francisco, and UC San Diego—to help curb the prevalence of HIV/AIDS in California. Aside from being the largest prevention pill-based program in the country, the demonstration project is also the first program in California to use PrEP treatment.

Two of the three campus teams will be engaged in a four-year program in which they will treat uninfected individuals with the HIV prevention pill (PrEP—pre-exposure prophylaxis), while HIV-positive participants will receive innovative medicine and post-infection treatment known as TLC+ (testing and linkage to care plus treatment).

The remaining group will not be implementing the TLC+/PrEP program; instead, they will lead a pilot PrEP/TLC+ plan to target young, uninfected men of color who engage in high-risk activities. These programs will provide information to young, high-risk individuals about sexually transmitted diseases, counseling for risk reduction and sexually transmitted infection screenings.

Every group is derived from high-risk communities in California, including Oakland, Los Angeles, San Diego, and Long Beach. Despite the project’s ambitious objectives, other initiatives with similar goals have not produced highly successful outcomes—a problem attributed to the failure of treated individuals to consistently take their medication. Those involved in the project, however, have noted that their study is much broader and differs from previous studies in several important ways.

“This demonstration project provides a unique opportunity to rigorously evaluate the feasibility, acceptability, and effectiveness of biomedical HIV prevention strategies that have shown efficacy for reducing HIV transmission but have not been tested more broadly in high-risk communities outside of the clinical trial setting,” stated Dr. Jennifer Sayles, medical director at the Los Angeles County Department of Public Health, in an article by the UC Newsroom.

The study mainly targets men of color who have sex with other men (MSM) and lack resources for testing and counseling. This research aims to produce positive results by decreasing infection rates and providing medication to HIV-positive individuals.

“Young MSM of color in urban California are especially vulnerable to HIV, with annual rates of new infection comparable to those in sub-Saharan Africa…With CHRP’s support, we hope to implement and evaluate promising new interventions to stem the relentless surge of HIV through our community, potentially reducing its terrible toll on young lives and its costs to our health care system,” stated Dr. Jeffrey Burack of the East Bay AIDS Center.

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AIDS Advocates Support PrEP in Statement to the FDA

On Thursday, May 10, the FDA’s Antiviral Drugs Advisory Committee (ADAC) will meet to review and consider Gilead Sciences' application for a prevention indication for the anti-HIV treatment drug Truvada (TDF/FTC). This is a critical moment in biomedical HIV prevention.

AVAC, a global advocacy group for HIV prevention, has created a website as a home for updates on the FDA review process and links to comments from a range of advocates. This also includes details on how to watch or attend the deliberations and information on an advocates’ follow-up teleconference planned for the week of May 14.

A group of leading AIDS organizations provided a statement to the FDA in support of approving Truvada for use in pre-exposure prophylaxis. The statement, in part, reads:

“In this country, over 50,000 annual HIV infections occur despite our best efforts to prevent them. The President’s National HIV/AIDS Strategy (NHAS) states: ‘We must also move away from thinking that one approach to HIV prevention will work, whether it is condoms, pills, or information. Instead, we need to develop, evaluate, and implement effective prevention strategies and combinations of approaches.’

“Adding a new biomedical option assists in that government endorsed program by expanding choices and combinations typical of other health prevention efforts. We support approval of the efficacy supplement for TDF/FTC (PrEP) with appropriate labeling, cautions, and supportive post-marketing requirements to prevent HIV-1 infection in all adult men and women.”

Signatories to the statement include AIDS Foundation of Chicago, AIDS United, AVAC Global Advocacy for HIV Prevention, Black AIDS Institute, International Rectal Microbicide Advocates, National Minority AIDS Council (NMAC), Inform, and the AIDS Foundation of San Francisco.

Read the letter in its entirety here

If you are in the DC area next week, you are encouraged to attend the meeting. If you are unable to attend in person, you can follow the proceedings via live webcast. Further information on the webcast, including the web address for the webcast, will be made available at least two days in advance of the meeting on the FDA website.

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“None Born Positive” Campaign Supports HIV-Positive Pregnant Women

The Pediatric AIDS Chicago Prevention Initiative (PACPI) has partnered with the AIDS Foundation of Chicago (AFC) and the Cause Marketing Initiative at the Medill School of Journalism, Media, Integrated Marketing Communications at Northwestern University to launch a public education initiative called “None Born Positive.”

Across Chicago, starting April 30 public transit and bus shelter ads appeared that encourage people to know their HIV status and to call PACPI if they’re HIV-positive and pregnant (or considering pregnancy).

“It's so important for women to realize why knowing their status is critical. Everyone should get tested and know their status—not just pregnant women who can prevent the transmission of HIV to their infants,” said Anne Statton, executive director of PACPI.

The “None Born Positive” ads also encourage people to donate to support PACPI’s substantial efforts in eliminating mother-to-child transmissions of HIV. The Chicago-based organization helps fund and develop HIV-specific prenatal classes, a statewide hotline for pregnant HIV-positive women, enhanced case management linking HIV-positive women to care, and rapid testing in Illinois hospitals.

PACPI served 133 women in 2011 and their success is easily measured: No HIV-positive births were reported among the 69 HIV-positive women who gave birth in 2011.

“The reduction of mother-to-child transmissions has been one of the great victories in the ongoing fight against AIDS,” said David Ernesto Munar, AFC’s president/CEO. “In 2012, no child should be born with HIV. PACPI’s work is focused on making that a reality.”

Join the conversation on Twitter (twitter.com/PACPI) using the hashtag #nonebornpositive or Facebook. The campaign also features radio public service announcements (PSAs) and online ads. To see all four “None Born Positive” ads and hear the PSAs, click here.

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FDA Approves Pediatric Dosing of Lexiva

On April 27, the Food and Drug Administration (FDA) approved dosing recommendations for use of GlaxoSmithKline’s protease inhibitor Lexiva (fosamprenavir) oral suspension in pediatric patients.

Data submitted to the FDA included three studies to support a new dosing regimen for Lexiva, with Norvir (ritonavir), in combination with other antiretroviral drugs, for the treatment of HIV-1 infection in pediatric patients from at least 4 weeks up to 6 years of age.

The Lexiva label now includes dosing for pediatric patients aged at least 4 weeks to 18 years. The dosage of Lexiva should be calculated based on body weight (kg) and not exceed the recommended adult dose.

Twice-daily dosage regimens by weight are as follows for both protease inhibitor-naïve and protease inhibitor-experienced pediatric patients at least four weeks of age (Lexiva plus ritonavir is not recommended for protease inhibitor experienced pediatric patients less than six months of age):

Alternatively, protease inhibitor-naïve children who are at least two years of age can be administered Lexiva (without ritonavir) in a dose of 30 mg/kg twice daily.

Lexiva should only be administered to infants born at 38 weeks gestation or greater and who have attained a post-natal age of 28 days.

For pediatric patients, pharmacokinetic and clinical data do not:

• support once-daily dosing of Lexiva alone or in combination with Norvir
• support administration of Lexiva alone or in combination with Norvir for protease inhibitor‑experienced children younger than six months of age
• support twice-daily dosing of Lexiva without Norvir in pediatric patients younger than two years of age

The complete updated labeling will be posted soon to Drugs@FDA.

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UCLA Launches Matching Program for HIV/AIDS Study Volunteers

The substantial progress in the fight against AIDS over the years is due in large part to the development of medications and other therapies that control HIV and treat many of the complications of AIDS.

Also important in this fight are behavioral studies examining various aspects of the disease, laboratory research to better understand HIV, and clinical trials of new therapies to treat HIV and its complications. Researchers rely on people being willing to help with such studies and to test the efficacy of new treatment and prevention approaches. However, it is often difficult to recruit study volunteers. To fill that gap, the UCLA Center for AIDS Research (CFAR)/AIDS Institute has initiated the HIV Research Study Volunteer Project, or RSVP.

RSVP matches volunteers with studies in which they might be eligible to take part. In addition to linking potential volunteers to appropriate studies, RSVP allows investigators to quickly enroll people in their studies and move forward with their investigations.

“One good way to describe RSVP is as a clinical trial and research dating service—like Match.com for research,” said Faith Landsman, director of RSVP. “We are accepting HIV-positive and HIV-negative men, women, and transgender [individuals] who are interested in learning more about HIV research at UCLA.”

When volunteers choose to enroll, they will be asked to fill out a detailed questionnaire, either online or by mail. Volunteers will be asked to provide personally identifiable information (PII) that includes their name, age, date of birth, email address, and telephone number.

They'll also be asked for non-personally identifiable information (non-PII), including: race/ethnicity, gender, HIV status, the antiretroviral drugs they are taking if appropriate, and any other health conditions they may have. They may also specify the type of research they are interested in and how they wish to be contacted about possible research studies.

“The more information the volunteer fills out, the more accurately we'll be able to match them with the appropriate studies,” Landsman said. Both types of information will be kept in separate, secure databases built by the UCLA Computing Technologies Research Lab. The information will be available only to RSVP personnel and will be used only for purposes of matching potential volunteers to studies.

Investigators who launch a study will complete an RSVP request that includes the subject criteria they seek. RSVP staff will search the database for potential volunteers meeting those standards and will then contact them via telephone, email, or postal service, as specified by the individual. Only RSVP staff will contact a volunteer and none of the emailed or mailed communications will include the term “HIV.”

Volunteers will be provided with a short description of the research study and with information about how to make contact with the research team if they are interested in participating in the study. Those who decide to take part must contact the investigator directly, so the volunteer remains in control over which studies they are a part of.

Volunteers can at any time ask to be removed from RSVP. Once they do so, all of their information will be permanently removed from the database and destroyed.

Anyone over age 18 can enroll online here. Volunteers must be able to make their own medical and legal decisions rather than having someone else, such as a guardian or conservator, do so, and they should be willing to be contacted about upcoming research trials.

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AIDS Memorial Quilt Returns to D.C.

At 47,000 panels, the AIDS Memorial Quilt is bigger than any available space in which to display it in its entirety, so sections of it will be on display in several Washington, D.C. locations this summer, including the National Mall.

Sections of the Quilt will first be displayed as part of the Smithsonian Folklife Festival from June 27 to July 1 and from July 4 through 8 on the Mall. In a program called “Creativity and Crisis: Unfolding the AIDS Memorial Quilt,” craft demonstrations, dance and music performances, interactive discussions, and other activities will show how communities have tried to educate people and deal with the crisis and grief of the HIV epidemic.

Also on the Mall, as well as 40 other locations throughout the city, the Quilt sections will be displayed during the International AIDS Society Conference (AIDS 2012) taking place July 21 – 25.

The NAMES Project Foundation is currently touring the country with the “Call My Name” campaign—an effort to encourage the creation of panels for those in the African American community lost to AIDS. Call My Name, the NAMES Project, and A Church for Me MCC, a local church for the LGBT community, partnered with TPAN to present a workshop where about 20 volunteers worked on panels for the agency and for those they’ve lost.

The NAMES Project team will also visit Atlanta, Boston, Houston, Jackson, Mississippi, Los Angeles, Philadelphia, Tallahassee, and San Francisco before returning to Washington, D.C.

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Legislation Watch

It’s been a quiet week in Lake Woebegone the halls of Congress. Except for the Violence Against Women Act passing the Senate on April 26, the flap over student loan interest rates, and squawking about whether there is or is not a “war on women” (Senators Lisa Murkowski, Olympia Snowe, and Kay Bailey-Hutchison, all Republicans, all agree that there is), most of the drama in our politics came from the Occupy May Day marches.

But there were some additional co-sponsors added to some of our favorite bills. H.R. 4470, which requires all insurance plans to cover routine HIV screenings, gained Yvette Clarke and Maurice Hinchey of New York, Raul Grijalva of Arizona, Judy Chu of California, Alcee Hastings of Florida, and Hansen Clarke of Michigan, Democrats one and all.

H.R. 3053, the REPEAL Act (Repeal Existing Policies that Encourage and Allow Legal HIV Discrimination Act) gained Ms. Chu of California.

And just a bit of interesting, non-legislative news—Richard Grenell has resigned as a foreign policy spokesman for the Romney campaign following criticism from some social conservatives, including the American Family Association, for having an openly gay man on the campaign.

Grenell thanked Romney for his confidence and for sending the message that having an openly gay man on his staff was a “non-issue.”

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