IRMA applauds the launch of the world’s first-ever Phase II rectal microbicide trial. The Microbicide Trial Network’s study, called MTN-017, will test a reduced glycerin formulation of tenofovir gel applied rectally. Volunteers consisting of gay men, other men who have sex with men, and transgender women will participate in the study at sites in the United States and in Thailand, South Africa, and Peru.
02 October 2014 | IRMA
An experimental single-tablet regimen containing a new version of tenofovir (tenofovir alafenamide or TAF) and the HIV protease inhibitor darunavir (Prezista) worked as well as a similar regimen containing the older tenofovir disoproxil fumarate (TDF) formulation,but it had less detrimental effects on kidney function and bone density, as study presented at the recent ICAAC conference heard.
09 September 2014 | HIVandhepatitis.com
Social/behavioral intervention vastly increased the number of African American and Latino individuals living with HIV/AIDS who enrolled in HIV/AIDS medical studies, a study has found. Nine out of 10 participants who were found eligible for studies decided to enroll, compared to zero participants among a control group.
08 July 2014 | Science Daily
Merck (MSD) today announced that the first patient has been enrolled in the company’s global Phase 3 clinical trial, ONCEMRK. ONCEMRK is assessing a once-daily investigational formulation of ISENTRESS® (raltegravir), known as reformulated raltegravir, as part of combination HIV therapy for treatment-naïve HIV-1-infected adults. Raltegravir combines high potency with low toxicity but its more widespread use has been held back by its needing to be taken twice a day.
06 June 2014 | Merck
The randomized controlled trial, or RCT, represents the gold standard of interventional studies of new drugs. But how reliable are the results when it remains unknown whether subjects in the trial actually took their medicines at all? A 2007 analysis found that only 33% of 192 papers describing RCTs of oral therapies for six chronic diseases disclosed adherence results.
13 May 2014 | Nature Medicine
The benefits of the iPrEX trial have been localized - most volunteers in Peru, Ecuador, Brazil, Thailand and South Africa no longer have access to the drug.
06 May 2014 | Poz
A Spanish HIV/AIDS researcher is facing a hefty fine for violating clinical trial regulations. Vicente Soriano, a well-known clinical researcher with hundreds of publications to his name, is liable for €210,000 for conducting a clinical trial without approval from the Spanish Agency for Medicines and Health Products, failing to obtain insurance for the trial, and informing participants he had his hospital's ethical approval when he did not.
31 January 2014 | Science
As the FDA seeks to approve drugs not only more quickly but also accommodate a growing clamor to exhibit more flexibility for endorsing therapies for life-threatening diseases, a curious wrinkle has emerged – there is a wide variation in the quality of underlying evidence used for approvals.
22 January 2014 | Forbes
The lack of data on the effectiveness of medicines available to doctors and researchers is "of extreme concern" say a group of MPs.
The Public Accounts Committee is calling for all data on drugs being prescribed in the UK to be made available.
03 January 2014 | BBC Health
Principal investigators and clinical trials units (CTUs) have been chosen to lead and conduct the research of five HIV/AIDS clinical trials networks through 2021. The effort is directed and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Total funding for the networks' leadership and the CTUs is expected to reach $225 million in 2014, the first year of operation.
30 December 2013 | NIAID press release