6th IAS Conference On HIV Pathogenesis, Treatment and Prevention


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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

Background: 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.
Methods: 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.
Results: 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).
Conclusion: 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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