MOAA0103 - Oral Abstract Session
Effect of intensification of long-term highly active antiretroviral therapy (HAART) with raltegravir on proviral HIV-1 DNA in gut associated lymphoid tissue (GALT): a randomized, placebo controlled trial
Presented by Jason Brunetta (Canada).
C. Kovacs1, J. Brunetta1, T.-W. Chun2, G. Smith1, R. Halpenny3, D. Su4, O. Mario5, G. Kandel5, R. Kaul4, J. Raboud4, M. Loutfy1
1Maple Leaf Medical Clinic, Toronto, Canada, 2National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, United States, 3Canadian Immunodeficiency Research Collaborative, Toronto, Canada, 4University Health Network, Toronto, Canada, 5St. Michael's Hospital, Toronto, Canada
To determine if intensification of long-term HAART with raltegravir is
associated with a change in the level of proviral HIV-1 DNA in CD4+ T cells in
GALT at 48 weeks of follow-up.
A prospective, double-blind, placebo-controlled study of 24 HIV-infected
individuals with sustained virologic suppression for a minimum of 4 years on
their first regimen was conducted. Patients were randomized to receive
either raltegravir 400mg twice/day or placebo for 48 weeks. GALT was
acquired using sigmoid colon biopsies.
The primary outcome of the study was to evaluate the mean change in the
frequency of CD4+ T cells carrying proviral HIV-1 DNA in GALT from baseline to
week 48 between the two groups. Placebo participants were rolled over to the
intervention arm at week 48 and all patients were then followed to 96
weeks. Changes in post- and pre-intensification values between the two
groups at week 48 were compared using ANCOVA.
There were no significant differences between the two groups with respect
to any demographic variables, including duration of HIV diagnosis and baseline CD4+ cell count.
Mean baseline levels of proviral HIV-1 DNA in GALT were 3.01(log10
copies/106 CD4+ T cells) [standard deviation (SD)=0.59] and
3.04(log10 copies/106 CD4+ T cells) (SD=0.48) in raltegravir and
placebo patients, respectively (p=0.88). The mean (SD) change in the
level of proviral HIV-1 DNA in CD4+ T cells in GALT from baseline to week 48
was -0.165 (0.267) and -0.123 (0.266) for patients randomized to raltegravir
and placebo, respectively (p=0.72).
In virologically suppressed patients on stable long-term HAART,
intensification with raltegravir did not result in decay of HIV viral
reservoirs in GALT CD4+ T-lymphocytes obtained from sigmoid colon biopsies at
48 weeks of follow up.
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