Last updated on April 2018

Safety and Efficacy of Fixed Dose Combination Dolutegravir/Abacavir/Lamivudine FDC Initiated During Acute HIV Infection

Brief description of study

This is a multicenter, single arm, 96-week open-label study of the safety and virologic efficacy of fixed dose combination Dolutegravir/Lamivudine/Abacavir (DTG/3TC/ABC FDC) initiated during acute HIV infection (AHI).

Detailed Study Description

The study will be conducted at the University of North Carolina in Chapel Hill, NC and Duke University in Durham, NC. All forty (40) participants will be enrolled for 96 weeks and will receive DTG/3TC/ABC FDC.

We propose to evaluate the efficacy and time to viral suppression with DTG/3TC/ABC FDC as initial therapy for AHI (acute HIV infection), as well as the feasibility of prompt administration using a rapid HLA-B57 (human leukocyte antigen) screening antibody assay. In addition to validating the restriction of RCI (resting cell infection) by ART (antiretroviral therapy) including a DTG-based regimen initiated during AHI, we will seek correlations between low RCI, residual GALT (gastrointestinal associated lymphoid tissue) HIV expression, and measures of immune activation. We hypothesize that rapid reduction in plasma viremia with this regimen will limit the area under the pre-ART viral load curve, and thus reduce the latent reservoir size as measured by a viral outgrowth assay one to two years following ART start, and as compared with the latent reservoir size in acutely infected individuals started on regimens without an integrase inhibitor based regimen. In addition, we will examine the longitudinal impact of the proposed integrase-based regimen initiated during the acute period on immune activation through week 96. If residual viral expression and persistent immune dysfunction is related to the burden of the latent viral reservoir (and presumably its periodic activation) these abnormalities should be ameliorated by early ART with rapid viral suppression. Finally, we will evaluate dolutegravir levels in plasma and GALT and whether rapid viral suppression with the proposed dolutegravir-based ART regimen impacts HIV RNA levels in GALT.

Clinical Study Identifier: NCT02384395

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JoAnn Kuruc, MSN, RN

University of North Carolina
Chapel Hill, NC United States
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Mehri McKellar, MD

Duke University Health System
Durham, NC United States
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Recruitment Status: Open

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