Shionogi-GlaxoSmithKline Pharmaceuticals to Revise Protocol for a Clinical Study of S/GSK1349572
AIDS Healthcare Foundation Announces “LOVE Condoms” Campaign
Alabama Will Allow HIV-Positive Inmates To Participate In Work Release Programs
Shionogi-GlaxoSmithKline Pharmaceuticals to Revise Protocol for a Clinical Study of S/GSK1349572
In an August 13 press release, Shionogi-GlaxoSmithKline Pharmaceuticals, LLC, in collaboration with the European AIDS Treatment Group (EATG) and the Drug Development Committee (DDC) of the AIDS Treatment Activists Coalition (ATAC), announced plans to revise inclusion criteria for their clinical study ING112276. The researchers seek to study dose ranges for the investigational integrase inhibitor S/GSK1349572 (or 572, for short) in antiretroviral treatment-naive patients.
According to the release, “In response to evolving regulatory recommendations and HIV community consensus on the appropriate patients to include in dose-ranging studies of investigational agents, the amendment increases the minimum allowable CD4+ cell count to 200 cells/mm3 (or higher, as local guidelines dictate). Patients with lower CD4+ counts should be treated with established standard of care agents, as their immediate need for therapy is greater.”
Dr. Garrett Nichols, co-project leader for the clinical development of 572, said, “Working together, we are able to draw upon the collective expertise of the HIV community, patients, clinicians, researchers, and regulatory agencies to develop new medicines for the treatment of people living with HIV and AIDS."
"Having pharmaceutical companies listen to and incorporate the concerns of AIDS activists is critical to designing safe and effective trials of HIV drugs," said David Evans, co-chair of the DDC. "This is a good example of how that process can and should work. Activists have never sought to unnecessarily slow down drug development, only to promote the well-being of those who volunteer for the studies. That will be accomplished with this protocol amendment, and we are pleased that GSK is equally committed to prioritizing patients."
“This has been an issue that the EATG has been working on for some time,” says PA Editor Jeff Berry, who, along with Evans, serves as co-chair of the DDC. “It was not only important for us to work together with our European counterparts and to be able speak with one collective voice on this issue, but also for GSK to be willing to listen and make the necessary change to the study. It demonstrates the continued need for community input on drug development and trial design early on, and the critical role that the DDC and EATG play.”
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AIDS Healthcare Foundation Announces “LOVE Condoms” Campaign
On August 12, at the House of Blues in Los Angeles, AIDS Healthcare Foundation (AHF) announced the launch of its popular “LOVE Condoms” campaign. The “LOVE Condoms” effort includes the installation of free condom dispensers at nightclubs and bars throughout Los Angeles stocked with AHF’s own specially-branded “LOVE” condoms. Many Los Angeles-area bars and nightclubs are already participating in the campaign.
In addition to the condoms, another key component of the campaign is the website www.getfreecondoms.org, which is designed to provide sexual health information and promote condom use. Organizations and individuals can also order a limited number of free condoms through the site.
AHF’s domestic “LOVE Condoms” campaign is part of an innovative, worldwide HIV prevention and awareness initiative and has already launched with great success in several countries, including India, Swaziland, Lithuania, Ukraine, South Africa, Estonia, Thailand and Uganda.
“The ‘Love Condoms’ campaign is just the beginning of a global movement that can take safer sex to a higher level worldwide,” said Michael Weinstein, President of AIDS Healthcare Foundation. “With new leadership in Washington, D.C. vowing to base public health initiatives on science rather than on politically or religiously motivated agendas, now is the time to call for condoms to be brought back to the forefront of HIV/AIDS prevention efforts. Lives are at stake.”
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Alabama Will Allow HIV-Positive Inmates To Participate In Work Release Programs
According to an August 13 report in the Birmingham News/Huntsville Times, the Alabama Department of Corrections has reversed a long-standing policy which restricted HIV-positive prisoners from participating in work release programs. The change in policy is a victory for the American Civil Liberties Union, which has fought to end the discriminatory practice for decades.
Richard Allen, commissioner of the Department of Corrections, said, "It was just time. When those inmates first went into prison, people didn't know how HIV was transmitted and they were scared to death. As we've learned about HIV, people now realize it's not like swine flu; you can't get it from shaking hands. The attitude toward those inmates has changed considerably."
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