PPD has secured a renewal of a decades-long research assistance contract with the Division of AIDS (DAIDS) within the NIH’s National Institute of Allergy and Infectious Diseases (NIAID).
NIAID/DAIDS is the sponsor of many IND applications, and to ensure clinical trials’ compliance with the U.S. and international regulations it has tapped PPD to provide clinical site and study monitoring services.
Under the contract, PPD is providing such monitoring services in research related to HIV or HIV co-infections as directed by the research institute. Those trials could span all four phases of clinical studies on HIV therapeutics and preventative vaccines, topical microbicides, and other prevention strategies, as well as for optimizing clinical management of HIV infection and co-morbidities, according to NIAID.
The services entail predicting risks to trial participant safety and data integrity based on measures of site performance and other risk factors, the CRO said in a press release. The CRO will offer its expertise both on site and remotely, said Patti McNamara, VP of government and public health services for PPD.
Through the deal, PPD will, among others, assist NIAID in two large-scale pivotal HIV trials the research institute just recently initiated.
One trial, dubbed HPTN 083, is testing ViiV’s injectable cabotegravir against Gilead’s oral med Truvada—the current regimen for HIV pre-exposure prophylaxis (PrEP)—on 4,500 people at 45 sites in eight countries. If that trial returns positive results in 2021, cabotegravir, which only needs to be injected once every eight weeks, could improve adherence to PrEP than Truvada, which requires daily intake.
The other study, called HVTN 702, initiated around last November, was the first HIV vaccine efficacy study around the world in seven years. For that phase 2b/3 trial, NIAID is testing an experimental vaccine regimen containing two vaccines by Sanofi Pasteur and GlaxoSmithKline, combined with a GSK-supplied adjuvant, in 5,400 sexually active men and women in South Africa. Results are expected in 2020.
NIAID/DAIDS and PPD first signed on the contract in 1990, and this recent renewal will see NIAID award PPD the contract on a yearly basis for up to seven years. The contract award for the first year is $15.2 million.