HIV Clinical Trial
Official title:
Towards Eradication: Reducing Proviral HIV DNA With Interferon-a Immunotherapy
The purpose of this study is to determine if treatment with pegylated interferon alpha 2b
(peg-IFN-α2b) will reduce the amount of integrated HIV DNA in peripheral blood cells and
tissues of individuals with chronic HIV infection receiving antiretroviral treatment (ART).
A reduction and/or clearance of the latent viral reservoir (i.e.: virus that remains dormant
in HIV-infected subjects receiving suppressive treatment ) is considered essential for HIV
eradication.
By measuring the changes in integrated proviral HIV DNA, which is considered a surrogate
measure of the latent reservoir, the investigators will establish if peg-IFN-α2b treatment
should be considered as a component of future viral eradication strategies.
Our long-term goal is to evaluate the effect of pegylated interferon (peg-IFN) α as an
anti-HIV reservoir immunotherapy that could potentiate eradication strategies against HIV.
The present study is a 3-arm randomized clinical trial (RCT). The aim of this study is to
determine whether a 20-week treatment course with 1μg/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 ART.
In addition, we will study if a 4-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% 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.
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