Rutgers involved in HIV clinical research trial
More than 1.2 million people in the United States are infected with human immunodeficiency virus (HIV), according to the Centers for Disease Control.
Rutgers—Newark’s own New Jersey Medical School (NJMS) is one site of the international Antibody Mediated Prevention (AMP) study on HIV prevention using the antibody VRC01.
HIV is a retrovirus that attacks T cells, which are used by the human body to fight infections. By reducing the number of T cells, HIV significantly incapacitates the body’s immune response to other pathogens, making it more likely for HIV-positive people to fall ill, according to AIDS.gov.
HIV can develop into acquired immunodeficiency disease (AIDS), which is fatal.
It is transmitted through bodily fluids, excluding those such as saliva, sweat and tears. These fluids are generally exchanged through sexual activity or sharing needles and syringes.
No cure currently exists for HIV, although through antiretroviral therapy (ART), a series of medicines, infected patients with HIV can control their symptoms and live almost as long as those without the virus.
Now a preventative therapy may present itself in the VRC01 antibody, said Shobha Swaminathan, Clinical Research Site Leader of the National Institutes of Health (NIH)-funded Clinical Trials Unit at the New Jersey Medical School.
VRC01 works by binding to a receptor of T cells, thus blocking HIV from attaching itself to the cell. It neutralizes over 90 percent of HIV strains, so there is evidence to believe it would prevent new HIV infection, she said.
“This particular antibody was originally isolated at the NIH in a patient with HIV infection who we otherwise call ‘elite controllers,’ meaning even though they have been exposed to HIV they really did not have detectable levels of the virus without taking any HIV medication,” she said.
Scientists will repeatedly infuse synthetically-manufactured antibodies into sample subjects so there will be no concern that somebody will acquire HIV from taking this particular antibody, she said.
Some will receive the antibody while some will receive a placebo. Each participant will have 10 infusions every eight weeks, according to the AMP website, and Swaminathan said the FDA will be periodically reviewing the scientists' practices to ensure patient safety.
The sample of the study consists of transgender men as well as men who have sex with men. In these groups, Swaminathan said risk of infection has increased significantly in the last few years.
Out of the population of 1.2 million HIV-positive people, 67 percent are gay or bisexual men. Black men also seem to be disproportionately affected by the virus.
This demographic is heavily present in Newark, making it an ideal place to study the effect of this vaccine. All participants are volunteers and part of the 2,700 people who will be part of this study, Swaminathan said.
“(The increased risk of infection) is linked to sexual risk, and lack of use of condoms and other barrier methods of prevention," she said. "There is some evidence that having sex under the influence of alcohol or drugs may also increase the risk of HIV in that population.”
Heterosexual men and women were 24 percent and 19 percent of the American HIV-positive population in 2014, respectively, according to the CDC. There is no reason to believe that the antibody will be less effective in heterosexual people and women, but Swaminathan said the studies must still be conducted with them.
The study at Newark began four months ago. Swaminathan said it is too soon to look the study's effectiveness.
An existing preventative treatment is PrEP, or HIV pre-exposure prophylaxis, a once-a-day pill that can be taken inside the clinic or outside of the study, she said.
“Participants have the right to take the pill in addition to the antibody if they choose to,” she said. "If there is a treatment available, and they want to use it, they should."
Ankita Patel, a School of Arts and Sciences sophomore, said she would get an HIV vaccine or antibody as a preventive measure.
“I don’t see why you wouldn’t take a preventative measure if something as serious as HIV or the complications that result from it can be prevented,” she said
One in eight people infected with HIV is undiagnosed.
NJMS is the only NIH-funded clinical trial unit that also provides “umbrella services," she said. The Rhine White program specifically treats those infected with HIV. Testing is free and results are ready in 20-30 minutes.
“There are other HIV programs that offer either testing or care treatment, probably
Megan Yuen, a School of Environmental and Biological Sciences sophomore, said that sexually-transmitted infection testing is free on campus and that she trusts the service.
“If I ever had an issue I think the first place I’d go to is Hurtado,” she said. “It is something that is really talked about so the fact that they’re actively working on something like this is really good.”
Namrata Pandya is a School of Arts and Sciences sophomore. She is a contributing writer for The Daily Targum.