Our long-term goal is to evaluate the effect of pegylated interferon alpha (peg-IFN-α) as an anti-HIV reservoir immunotherapy that could potentiate eradication strategies against HIV.
The present study is a three-arm randomized clinical trial (RCT). The aim of this study is to determine whether a 20-week treatment course with 1 μg/kg/week of pegylated interferon alpha 2 b (peg-IFN-α2b) will reduce the levels of HIV-1 proviral DNA levels in circulating PBMC and mucosa-associated lymphoid tissue (MALT) in HIV-infected individuals receiving long-term anti-retroviral therapy (ART).
In addition, we will study if a four-week interruption of ART is necessary to observe any change in proviral DNA levels.
In our previous study (NCT00594880) with a different form of interferon alpha (peg-IFN-α2a), we observed a reduction in proviral DNA in peripheral blood cells in 50 percent of the patients. However, we did not measure the levels in MALT, and we could not determine whether or not an interruption of ART was necessary. The present study will address these questions.
We will also seek to determine the biological mechanisms (such as an increase in Natural Killer cell cytotoxicity) that mediate the antiviral effects of peg-IFN-α.
For more information, please refer to our clinicaltrials.gov registration page.