Desert AIDS Project is studying a new treatment for a very pervasive sexually-transmitted infection (STI) that’s now become drug-resistant.

Under the direction of Dr. Steven Scheibel, D.A.P. is studying the efficacy, safety, and side effects of a drug that combats Nesseria gonorrhoeae, the bacteria that causes gonorrhea.

Gonorrhea is the second most common STI and a major source of morbidity worldwide. Without treatment, it can cause infertility, cervicitis, proctitis, urethritis, pelvic inflammatory disease, and pharyngitis. Babies grow outside the womb in some women and the infection makes both genders more susceptible to HIV, according to GlaxoSmithKline, sponsor of the study. They go on to say:

“The ability of Neisseria gonorrhoeae to develop resistance to antimicrobials has complicated the management of the disease, leading to an urgent need for new treatment options.”

D.A.P. is one of eight medical centers testing the new drug, called GSK2140944. The study invites 60 adults with gonorrhea infection to take a single dose of either 1,500-mg or 3,000-mg of GSK2140944. The study wants to know if the smaller or the larger dose works best. The study last about a week with two scheduled visits. On the first visit, doctors will dispense the drug and gather baseline information from the study subject. A follow-up visit, called the Test-of-Cure visit, occurs between day 4 and 8 and determines the subject’s response to the drug. That includes success, failure, and adverse effects. Although there are two scheduled visits, bad reactions to the new drug will be monitored until they are resolved.

So far, D.A.P. has enrolled three subjects in the study, to meet the six-subject goal for each site. Our clinical administrators are working on identifying additional subjects. “Right now, though, we have more subjects than any other site and we’ve enrolled them quickly,” says Rod Hagan, D.A.P.’s Clinical Research Coordinator. D.A.P. began accepting subjects about six weeks ago, while other sites have been at it since January. “We have a concentration of people in the Coachella Valley, who need support in fighting gonorrhea infection, so our services have to be cutting edge and we must be fast out of the blocks,” Dr. Scheibel states.

Although the name of the drug sounds like a chemical weapon from an action hero comic strip, the problem and the need for an immediate answer is very real.

According to the study protocol, a variety of antimicrobial agents have been used over the years for the treatment of gonorrhea. Effective treatment options for gonorrhea have diminished rapidly because of the emergence and worldwide spread of antimicrobial resistance to many drugs previously used or considered the first line. The study goes on to list six drugs that patients are taking to almost no effect.

“Azithromycin was the big tah-dah,” Rod says. “But N. gonorrhoeae has become resistant to it and there’s nothing else in the pipeline. Without a new treatment, it could be like it was at the turn of the century again and it could be fatal.”

D.A.P. is trying to keep that from happening. We’re participating in this study and several other clinical trials that aim to improve the lives of patients and clients living with HIV. The search for a new antimicrobial is one of five that D.A.P. has conducted in the past 12 months. Those studies include Medication Therapy Management, a study on HIV, aging, and the brain, a study that searches for a milder antiretroviral that we’ve called Switch, and a new treatment for anal dysplasia. These studies represent a new function we’ll perform for the HIV community here and abroad. Beyond those in disadvantaged communities in the Coachella Valley, many others — nationally and globally — will benefit from our findings.

“Our search for a new treatment for this drug-resistant strain of gonorrhea is one of the most important things we can do,” Dr. Scheibel says. “We have to get out in front of this challenge because it threatens us locally and globally.”

Dr. Steven Scheibel, Medical Director at Desert AIDS Project, believes he’s found a new way to treat the conditions that can lead to anal cancer. The new therapy uses human papillomavirus (HPV) vaccines in conjunction with an immune-boosting cream to kill anal dysplasia, which is often a gateway to anal cancer. This therapy promises to be an alternative to surgery as well as a way to address soaring rates of HPV and resulting dysplasia, which weighs so heavily on gay men and those with HIV.

Dr. Scheibel, along with Dr. Praveena Yetur of LabCorp in Monrovia, wanted to treat anal dysplasia, which manifests as lesions in the anal cavity. These lesions can range from mild to severe and may morph into cancer. Working with a 55-year-old man with moderate to severe anal dysplasia, the patient was given imiquimod cream followed by injections of an HPV vaccine called Gardasil. By intervals of three to four weeks, the treatments were delivered over a two-year period. “The patient was screened for high-risk HPV on a weekly basis and had multiple biopsies to identify possible dysplasia,” Dr. Scheibel says. “The result was no virus and a normal anal Pap smear.”

Treatment for HPV and anal cancer is essential at D.A.P. because they pose growing threats to many of our patients. HPV is the most common sexually-transmitted virus circulating today, with up to 75% of sexually active people contracting it in their lifetimes, according to Boston Medical Center’s website. Medical experts agree that HPV infection is even higher in people with HIV. And, although anal cancer is still relatively rare, its prevalence is growing fast, particularly among men who have sex with men (MSM) and those who are HIV-positive, says BioMedCentral.com.  In fact, anal cancer among MSM with HIV is rising at 80 times the rate of the general population, Dr. Scheibel reports. Therefore, D.A.P. is busy searching for answers to HPV, anal cancer, and other clinical issues that challenge our patients.

HPV also is a key factor in head and neck cancer, for which we offer free screenings to clients, staff, and the general public once a year through the Annette Bloch Cancer Care Center. Dr. Scheibel leads a movement to increase clinical research performed under our roof and has made notable headway in the area of HPV and anal dysplasia. The treatment has shown so much promise that Dr. Scheibel will present his findings at “HPV 2015,” the 30^th International Papillomavirus Conference in Lisbon, Portugal, held September 17-21.

Researching disease and sharing results with international colleagues, is not new to the internist, who specializes in infectious disease and is AAHIVS credentialed as an HIV Specialist. Dr. Scheibel has done clinical research on HIV and AIDS for decades and was a researcher as well as co-founder and Associate Medical Director of the Community Health Network in Rochester, N.Y., in 1989. He’s been on teams whose work is cited in books such as “Public Health Behind Bars: From Prisons to Communities.” Dr. Scheibel has presented at the Conference on Retroviruses and Opportunistic Infections, the Symposium on Cell Biology of Virus Entry, and he’s traveled to such cities as San Francisco, Casablanca, and Yokohama, Japan, to appear at the International Conference on AIDS.

Nevertheless, presentation at the HPV conference is special, says Rod Hagan, D.A.P.’s Clinical Research Coordinator: “If we could demonstrate a potential treatment for dysplasia that would prevent the need for the invasive surgical solutions that are out there, then this is huge. And getting the rate of HPV among our patients in line with that of the general population… yes, the potential of this is pretty exciting.”