Featured Research

from universities, journals, and other organizations

Phase II HIV gene therapy trial has encouraging results

Date:
February 19, 2010
Source:
University of Pennsylvania School of Medicine
Summary:
In a new phase II study using gene therapy to combat HIV, seven of eight subjects experienced a decrease in viral load set point and one subject experienced prolonged, complete control of HIV viremia for more than 14 weeks in the absence of HAART. The study looked at Lexgenleucel-T infusions in HIV-1 infected individuals prior to being taken off their antiretroviral treatment regimens as part of the study design's scheduled treatment interruption.

Researchers from the University of Pennsylvania School of Medicine presented the results from an ongoing Phase I/II open-label clinical trial of Lexgenleucel-T at the 16th Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco, CA on February 18. Lexgenleucel-T is a cell and gene therapy product being investigated for the treatment of HIV infection. The current study examined the effect of Lexgenleucel-T infusions in HIV-1 infected individuals prior to being taken off their antiretroviral treatment (HAART) regimens as part of the study design's scheduled treatment interruption.

In the study, seven of eight evaluable subjects experienced a decrease in viral load set point and one subject experienced prolonged, complete control of HIV viremia for more than 14 weeks in the absence of HAART. Viral load set point is the HIV RNA value specific for each infected individual in absence of anti-retroviral drug control. Higher viral load set point is correlated with more rapid disease progression to AIDS.

"We are excited to see these responses using autologous transfer of CD4+ T lymphocytes genetically modified with VRX496TM, a HIV-based lentiviral vector encoding for a RNA antisense targeting HIV env. These are subjects who were taken off of their antiretroviral treatment and are showing a better control of their infection as demonstrated by reduced viral load set points," said Pablo Tebas, M.D., director of the Adult AIDS Clinical Trials Unit, who presented the results at CROI. "Further study is needed to see whether these types of results will translate into a delay in disease progression."

In the current study, several administrations of Lexgenleucel-T, each comprising approximately 1010 autologous CD4+ T cells transduced ex vivo with VRX496TM, were administered to 17 HIV-1 infected subjects who were fully suppressed on HAART. Each subject received three to six separate infusions over a period up to 13 weeks. Six weeks after the last infusion, eligible subjects underwent a scheduled treatment interruption to evaluate timing to HIV RNA recrudescence, changes in viral load set point and changes in CD4 T cell count. Of the 17 subjects who received infusions, 13 (76%) underwent the scheduled treatment interruption. Eight of these 13 subjects (62%) were evaluable for the efficacy endpoint. Overall, 7 of 8 (88%) of the evaluable subjects had a decrease in viral load set point ranging from -0.26 to -0.98 Log10. One subject maintained a complete control of HIV RNA viral load below the limit of detection (50 copies/ml) and a CD4+ cell count greater than 1200 cells/L for over 14 weeks.

"It is notable that all patients on the protocol had elevated CD4+ counts after treatment with Lexgenleucel-T," said Carl June, M.D., professor of Pathology and Laboratory Medicine. "Achieving a complete control of HIV recrudescence following HAART interruption for over 14 weeks is, indeed, remarkable."

Pablo Tebas, MD, David Stein, MD, Gwendolyn Binder, PhD, Larisa Zifchak, RN, Angelo Seda, RN, Jean Boyer, PhD, Faten Aberra, MD, Ronald Collman, MD, Gerard McGarrity, PhD, Bruce Levine, PhD and Carl June, MD, are all co-authors of this study. The study was funded by the NIH, NIAID. Drs. Tebas, Zifchak, Boyer, Aberra and Colman are affiliated with the Center for AIDS Research at the University of Pennsylvania, Philadelphia. Drs. Binder, Levine, June, and Boyer are affiliated with the Department of Pathology and Laboratory Medicine, University of Pennsylvania, Philadelphia. Drs. Stein and Seda are affiliated Jacobi Medical Center, Bronx, New York. Dr. McGarrity is an employee of VIRxSYS Corporation, Gaithersburg, Maryland. VIRxSYS is the owner of the Lexgenleucel-T therapy. No author on this study other than Dr. McGarrity is affiliated with VIRxSYS in any capacity beyond their roles as clinical collaborators on this project.


Story Source:

The above story is based on materials provided by University of Pennsylvania School of Medicine. Note: Materials may be edited for content and length.


Cite This Page:

University of Pennsylvania School of Medicine. "Phase II HIV gene therapy trial has encouraging results." ScienceDaily. ScienceDaily, 19 February 2010. <www.sciencedaily.com/releases/2010/02/100218191736.htm>.
University of Pennsylvania School of Medicine. (2010, February 19). Phase II HIV gene therapy trial has encouraging results. ScienceDaily. Retrieved October 22, 2014 from www.sciencedaily.com/releases/2010/02/100218191736.htm
University of Pennsylvania School of Medicine. "Phase II HIV gene therapy trial has encouraging results." ScienceDaily. www.sciencedaily.com/releases/2010/02/100218191736.htm (accessed October 22, 2014).

Share This



More Health & Medicine News

Wednesday, October 22, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

CDC Revamps Ebola Guidelines After Criticism

CDC Revamps Ebola Guidelines After Criticism

Newsy (Oct. 21, 2014) The Centers for Disease Control and Prevention have issued new protocols for healthcare workers interacting with Ebola patients. Video provided by Newsy
Powered by NewsLook.com
WHO: Ebola Vaccine Trials to Start a in January

WHO: Ebola Vaccine Trials to Start a in January

AP (Oct. 21, 2014) Tens of thousands of doses of experimental Ebola vaccines could be available for "real-world" testing in West Africa as soon as January as long as they are deemed safe in soon to start trials, the World Health Organization said Tuesday. (Oct. 21) Video provided by AP
Powered by NewsLook.com
First-Of-Its-Kind Treatment Gives Man Ability To Walk Again

First-Of-Its-Kind Treatment Gives Man Ability To Walk Again

Newsy (Oct. 21, 2014) A medical team has for the first time given a man the ability to walk again after transplanting cells from his brain onto his severed spinal cord. Video provided by Newsy
Powered by NewsLook.com
CDC Issues New Ebola Guidelines for Health Workers

CDC Issues New Ebola Guidelines for Health Workers

Reuters - US Online Video (Oct. 21, 2014) The U.S. Centers for Disease Control and Prevention has set up new guidelines for health workers taking care of patients infected with Ebola. Linda So reports. Video provided by Reuters
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins