NARES²- history

Nevada AIDS Research and Education Society and Nevada Access to Research and Education Society, NARES² , was founded in 1994 by Drs. Jerry Cade and Jim Christensen as a means of ensuring that individuals in Southern Nevada had access to the latest and best therapies available. Drs. Cade and Christensen are the co-directors of University Medical Center’s (UMC’s) HIV Service. In addition, Dr. Jim Christensen has an established allergy and asthma practice and was already actively engaged in clinical research in 1994. In order to help diversify NARES² and ensure its survival, Dr. Christensen folded his successful research efforts into NARES² .

Although we were unaware of it at the time, 1994 was the beginning of a dramatic change in HIV treatment, which was to transform HIV from a fatal disease to one that could be controlled over time. NARES² simple mission in 1994 was to ensure that People Living with HIV/AIDS had access to the promising new treatments that were becoming available. As People Living with HIV/AIDS began to live longer, more productive lives, NARES² was able to expand its efforts to include the first AIDS vaccine, psychosocial research and other general internal medicine studies as well as continued research on new HIV/AIDS therapies and drugs for asthma and other respiratory conditions.

As co-directors of UMC’s HIV Service, Drs. Cade and Christensen oversee not only the dedicated HIV-inpatient unit at University Medical Center; but, they also serve as the co-directors (UMC’s) Wellness Center. The Wellness Center was the ideal partner for NARES² .

UMC’s Wellness Center was founded in December of 1986 by Drs. Jerry Cade and Melvin Pohl as a means of ensuring that HIV-infected patients had access to the first HIV medication, AZT, which had recently been approved by the FDA. The Wellness Center, which opened with five patients in 1986, now cares for over 2000 HIV-infected Southern Nevadans—about two thirds of all the HIV-infected patients in Clark County that are currently receiving medical care.

The majority of the patients at UMC’s Wellness Center are under the care of Drs. Brian Onbirbak and Gary Schroeder. In addition, Drs. Onbirbak and Schroeder see HIV-infected patients at the early intervention clinic at the Clark County Health District. Since 1994, Drs. Sal Biazzo, Dino Gonzalez, Alan Greenberg, Steve Lampinen, Kathleen Wairemu have become active participants in UMC’s HIV program as well as Lambda Health Care. These physicians continue to care for the overwhelming majority of HIV-infected patients in Clark County.

The research program at the Wellness Center has been carefully supervised since its inception by Dr. Dennis Fuller, a clinical pharmacist with HIV expertise. In addition to the HIV research program at the Wellness Center, Dr. Fuller oversees the clinical protocols at NARES² —ensuring that patients with HIV/AIDS have consistent and compassionate to access to research protocols.

It quickly became clear to the co-founders of NARES² , Dr. Jerry Cade and Dr. Jim Christensen, that this organization should be founded as a non-profit research association, so that any potential profits coming from research endeavors could be reinvested in the communities involved in clinical investigations.

Dramatic changes began to happen in at the end of 1995, when the first HIV protease inhibitor, Saquinavir® was approved by the Food and Drug Administration (FDA) in December of 1995. This was quickly followed by the approval of two more protease inhibitors, Ritonavir® and Indinavir® in March, 1996.

It was around this time, that HIV clinicians discovered that combination therapy was the answer to keeping the AIDS virus in check. An AIDS “cocktail” could potentially completely suppress the AIDS virus for an unlimited time. In 1996, some people were talking about curing AIDS. It was in 1996 that Dr. David Ho, an HIV researcher from New York who helped push the idea of combination therapy, was named Time Magazine’s “Man of the Year.” Unfortunately, we are not yet able to cure AIDS; however, HIV became a chronic controllable condition for most individuals.

New drugs were needed to stay ahead of the resistance that occurred with ongoing HIV therapy. As you can see from the list of trials in which NARES² participated, NARES² was an active participant in many of the clinical trials that lead to the discovery of these new drugs.

The FDA approves several levels of clinical trials. Most clinical trials are Phase III trials, which are performed after preliminary evidence suggesting effectiveness of the drug has been obtained in Phase II trials. Phase III trials gather the additional information about effectiveness and safety needed to evaluate the overall benefit-risk relationship of the drug. If successful, Phase III studies provide the basis for extrapolating the results to the general population and approving the drug. The majority of NARES² clinical trials are Phase III.

However, NARES² has also participated in Phase II clinical trials, which include early controlled clinical studies conducted to obtain preliminary data on the effectiveness of the drug for a particular indication or indications in patients. In addition, Phase II studies help determine the common short-term side effects and risks associated with the drug.

Even more rigorous, are Phase I clinical trials, which are the initial introduction of an investigational new drug into humans. These studies are designed to determine the metabolic and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. NARES² has also been a part of Phase I clinical investigations.

In 1997, NARES² become a part of VAXGEN’s AIDSVAX trial—the first Phase III clinical trial looking at a preventative AIDS vaccine. NARES² continues to be involved in other vaccine trials.

Despite the tremendous strides made with HIV drug therapy, the number of new HIV infections in the United States stopped declining and leveled off at about 40,000 new cases annually. For this reason, NARES² became involved in psychosocial research in an effort to improve prevention messages as well as help patients improve medication adherence. A partnership with Dr. Thom Reilly and Dr. Laurie Smith from the School of Social Work at the University of Nevada Las Vegas (UNLV) and Dr. Grace Woo, a statistician at the Harry Reid Center, also at UNLV, resulted in a rich data set that has produced several papers, which are highlighted on the NARES² accomplishments page. These relationships are ongoing and other partnerships for psychosocial research are being explored.

In 2000, NARES² expanded its mission and began participating in additional general internal medicine trials. NARES² had continued to do allergy and asthma studies since its founding in 1994. New directions for NARES² included clinical trials for diabetes, hypertension, hyperlipidemia, gout, urinary retention, peripheral neuropathy and other general internal medicine issues.

NARES² continues to broaden its vision. Unfortunately, many of the HIV-infected patients at the Wellness Center are co-infected with Hepatitis B and C. NARES² is looking at several clinical trials to address these concerns. Other infectious disease problems like oxacillin-resistant staphyloccal aureus (ORSA) call for more powerful, experimental antimicrobials. NARES² has already participated in these clinical trials and is looking at continued participation in others.

The clinical investigators for NARES² are all practicing health care providers as well as researchers. In addition to its research efforts, NARES² is actively involved in health care prevention and treatment efforts as well as health care education programs in Clark County. NARES² providers are active in many local community groups as well as on the boards of several national groups dedicated to health care and health care research. In addition, providers from NARES² are involved in multiple international HIV/AIDS initiatives.

NARES² was founded as a way to ensure that patients had access to the latest and best therapies available—even before they were approved by the FDA. For many patients, experimental therapies were the only hope left for a better quality of life. From that simple beginning, NARES² has become a multi-faceted and diverse research organization dedicated to creating a better world through health care research.

We look forward to working with you in that endeavor.

NARES2 - history

NARES²- history