Hospital Seeks HIV-Positive Adults for Clinical Studies of New Medications

Friday, January 14, 2011

FOR IMMEDIATE RELEASE

CONTACT:
Cynthia Bacon
718-670-2515
crm9002@nyp.org

New York Hospital Queens Clinical Research Studies Involving New Investigational Drugs for HIV-Positive Adults

Flushing, N.Y., January 14, 2011 – Today’s medications now enable people with HIV, the virus that causes AIDS, to live longer and healthier lives and without many of the debilitating and inconvenient side effects of earlier versions of medications. Scientists are always looking for better medications for HIV and one way that they do this is to create clinical research protocols to study new investigational drugs or new combinations of currently used drugs. New York Hospital Queens (NYHQ) is participating in several clinical research studies of new investigational treatments for people with HIV.

The clinical research studies at NYHQ are being conducted through the hospital’s Special Care Clinic under protocols approved by the NYHQ Institutional Review Board (IRB).  An IRB is designed to protect the people who take part in clinical research trials by ensuring certain safeguards are included in the study protocol. An IRB reviews every clinical research protocol to ensure that the studies are well designed, legal, ethical and to determine if any potential risks are worth the possible benefits that a patient may receive.

For some HIV-positive patients, there may be benefits to taking part in a clinical research study, also known as a clinical trial. Most importantly, participating in clincal trials may help future patients with this disease by allowing doctors to learn about new treatment options. In addition, some clinical trials provide the participants with no-cost health examinations, no-cost study medications and reimbursement for their transporation costs.

According to the World Health Organization, more than 33 million people are living with HIV worldwide and 2.7 million people are newly infected each year.  According to the New York City Department of Health, more than 107,000 New Yorkers are living with HIV, but thousands more do not know they are infected. HIV is the third leading cause of death for New York City residents aged 35 to 54. In 2008, there were 3,809 new cases of HIV diagnosed in New York City, 604 of those new cases were in Queens. 

The FDA has approved more than 25 antiretroviral drugs to treat HIV infection. These drugs can help people with HIV to improve their overall immune system function and status, suppress symptoms and improve their quality of life.

According to Sorana Segal-Maurer, M.D., attending physician in the Infectious Disease Division’s Special Care Clinic at New York Hospital Queens, “When the anti-HIV therapies now in widespread use are prescribed and taken correctly, a patient’s viral load can be suppressed completely, and AIDS-related illnesses and death can be delayed and/or prevented.”

Current FDA approved treatments are generally well-tolerated and available in the form of a few pills.  This has significantly improved patients’ ability to take their medications regularly.  However, research continues in an effort to create more single-tablet combination pills as well as develop new drugs for virus resistant to current FDA approved medications. “This is why our team constantly tests new drugs that are being developed. We want to find ones that will be as effective, more tolerable, have fewer side effects, and are in fewer tablets than those in current use,” said Dr. Segal-Maurer.

“We have several ongoing studies for which we are seeking HIV positive adults to enroll.” 

NYHQ’s Special Care Clinic is currently seeking patients for the following studies:

• Gilead 0106 -for people who are HIV-positive and virologically suppressed (no detection of the HIV virus for at least 6 months) on a protease inhibitor combination who are interested in switching from their existing HIV regimen to a once-a-day, single tablet investigational product (Truvada plus an investigational agent). 
• GSK ING 111762 SAILING -for people who are HIV-positive and have had resistance to two or more anti-HIV drugs during their treatment and have never taken an integrase inhibitor. Those who qualify will receive HIV treatment that may include a new integrase inhibitor which works in spite of resistant HIV.
• GSK ING 111467 SINGLE -for those who are HIV-positive and are “naïve” to treatment, meaning they have not had any previous anti-HIV therapy. Patients who qualify may receive treatment that may contain an investigational drug.

Individuals must be 18 years of age or older and not pregnant or breastfeeding to participate. Individuals can learn more about these trials and to see if they qualify to participate by calling (718) 670-2530.

The Infectious Disease Division in the Department of Medicine at New York Hospital Queens provides clinical consultations for inpatients and outpatients with infectious diseases in response to requests by NYHQ-affiliated physicians or those practicing in the community. The division also serves as a New York State AIDS Designated Center, providing ongoing care on an outpatient basis for approximately 800 HIV-infected individuals in the Special Care Clinic.

New York Hospital Queens is a member of the NewYork-Presbyterian Healthcare System and an affiliate of the Weill Medical College of Cornell University.

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Note to editors: Dr. Sorana Segal-Maurer is available to discuss the state of HIV infection in New York City and Queens. Interviews can be arranged by contacting Cynthia Bacon, (718) 670-2515 or crm9002@nyp.org.