Dr. Tulika Singh co-authors major HIV clinical research study
By Robert Hopwood
Published: June 18, 2021
DAP Health is gaining recognition from the clinical research trials underway at the health center.
The results from a clinical research trial that DAP Health conducted were published online in early June by the medical journal AIDS. Additionally, the results will be published in the printed journal.
Dr. Tulika Singh, associate chief medical officer and director of research at DAP Health, co-authored the published manuscript that reports the study's findings.
The ViiV Healthcare STAT Study researched if the antiretroviral drug Dovato could be used in a rapid start setting, said Greg Jackson, the clinical research manager at DAP Health. Study participants began the medication within 14 days of their HIV diagnosis.
ViiV Healthcare is a London-based pharmaceutical company. Its U.S. headquarters is located in North Carolina’s Research Triangle Park.
"We've now become a preferred site for ViiV Healthcare's research because of our successes," Jackson said.
The FDA will look at the data from the STAT study and decide if doctors can prescribe Dovato to people within days of an HIV diagnosis.
DAP Health recruited 14 adults for the STAT study, Jackson said. That was the third-highest number of participants recruited among the organizations conducting the study. In total, the study had 131 participants.
"It has been an exciting honor to be part of the STAT study and being able to contribute to the science and the success of the rapid start treatment regimen for Dovato," Singh said.
The STAT study, which concluded in 2020, will be presented at the 11th IAS Conference on HIV Science in July. It was one of several studies underway at DAP Health.
Currently, there are three active clinical research trials at the health center. DAP Health is studying whether patients can switch their current antiretroviral therapy drug for another, if a long-lasting injectable treatment for HIV can supplant a daily pill, and if screening and treatment of precancerous cells can prevent anal cancer.
The most recent study launched by DAP Health was the Biktarvy SWITCH Study, which began in May 2021. Singh and Jackson co-authored the study.
Participants in the study, which is open to HIV-positive patients aged 65 or older, will be switched from their current antiretroviral therapy to Biktarvy, which combines three HIV medicines into one pill.
"With the advent of successful treatment regimens, more than 25% of people with HIV will be over the age of 65 by the year 2030," Singh said. "We are studying HIV regimens, such as Biktarvy, to determine the benefits to quality of life in patients 65 and older."
Gilead Sciences Inc., a Bay Area biopharmaceutical company, is collaborating with DAP Health in the SWITCH study.
DAP Health wants to enroll 50 patients in the study. So far, the health center has enrolled two people in the clinical research trial.
"It is a lot of work to find these patients," Jackson said.
The SOLAR study, a global clinical research trial, also is being done in collaboration with ViiV Healthcare. Recruitment for the study ended in June 2021.
Patients in the SOLAR study will switch their HIV medication for a long-acting injection, according to ViiV Healthcare. The goal is to develop an HIV treatment that offers patients more convenience; a treatment that is easier to adhere to; and an increased quality of life.
"The treatment of HIV has evolved tremendously over the past three decades to a point where patients can now get long-acting treatments rather than take a pill once a day," Singh said. "We are evaluating exciting regimens at DAP for safety and efficacy in where patients can get an injection once every two months to control their HIV."
The ANCHOR study, which is still accepting patients, is probing the best way to prevent anal cancer among people living with HIV. The National Cancer Institute of the National Institutes of Health is funding the collaborative study.
More clinical research studies are in the planning process, but unfortunately, Jackson could not go into details.