Replies to post #7544 on Avid Bioservices Inc (CDMO)

[cjgaddy]

Katie, BigTarvy wrote in #7505. “HCV Repeat Dose Trial: If HIV patient is known to have HIV infection, whether positive, active or chronic, patient will not be allowed in this trial. However, the trial sites are not testing for the presence of HIV infection, so it’s quite possible (indeed 40% likely) that many of the HCV patients will be co-infected.”

In your reply #7543, you said, “Are you implying that the research centers are enrolling patients unknowingly with HIV in the repeat dose study right now? You should be careful with these type of statements. Insinuating PPHM and their investigators are not abiding by the protocol parameters is not cool.”

Did a little Googling and I found many clinical trial protocols where the “No known HIV disease” exclusion is specified. Take this MDA example:

Study #2004-0595: Dr. Nicholas E. Papadopoulos, MDAnderson Cancer Center
“Ph.II Study of Temozolomide Thalidomide & Lomustine for Metastatic Melanoma in the Brain”
Exclusion Criteria:
11) No known HIV disease. Patients with a history of intravenous drug abuse or any other behavior associated with an increased risk of HIV infection should be tested for exposure to the HIV virus. Because peripheral neuropathies are a common toxicity of antiviral therapy and of viral infection in HIV patients, as well as a common significant toxicity with thalidomide, patients who test positive or who are known to be infected are not eligible. An HIV test is not required for entry on this protocol, but is required if the patient is perceived to be at risk.
http://utm-ext01a.mdacc.tmc.edu/dept/prot/clinicaltrialswp.nsf/Index/2004-0595

Not sure, but the reason you don’t see mandatory HIV Tests in trials may be this:
“Arbitrary exclusion of individuals with a prior malignancy or individuals known to be HIV-positive from extramural research potentially violates the Americans with Disabilities Act (ADA) and the Rehabilitation Act of 1973.”

Katie, I think the operative word is “KNOWN”, and I’m seeing “An HIV test is not required for entry on this protocol” come up over and over. I’m also not seeing any flaw in BT’s conclusion about the Repeat-dose HepC trial, “so it’s quite possible (indeed 40% likely) that many of the HCV patients will be co-infected [with HIV]”.