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Proposal 1403

Title of the Proposed Research

Mathematical modeling of the HIV transmission risk during the first 24 weeks after initiation of antiretroviral therapy in naïve HIV-infected MSM: comparison of INSTI-based regimens vs. nnRTI and PI based regimens.

Lead Researcher

Juan Berenguer

Affiliation

Hospital General Universitario Gregorio Marañón

Funding Source

An Investigator Sponsored Study (ISS) has been sent to ViiV Heath Care for conducting this study

Potential Conflicts of Interest

Has received research grants from: GILEAD, MSD, BMS, VIIV Healthcare
Has received honoraria for advisory boards and talks from ABBVIE, BMS, GILEAD, MSD, JANSSEN, VIIV Healthcare

Data Sharing Agreement Date

6 June 2016

Lay Summary

Scientific Rationale for Study / Scientific Study Objectives

The HIV epidemic among men who have sex with men (MSM) continues to expand in low, middle, and high-income countries. The disproportionate HIV disease burden in MSM is explained largely by the high per act and per-partner transmission probability of HIV transmission in receptive anal sex [1, 2]. Current strategies are inadequate to control HIV spread among MSM; much more vigorous prevention efforts are required, including the early initiation of antiretroviral therapy (ART) that has been shown to reduce the rates of sexual transmission of HIV-1 [3] and the adaptation and expanded use of pre-exposure prophylaxis (PrEP) to prevent the acquisition of HIV-1 infection [4]. Initiation of ART with regimens based on integrase strand transfer inhibitors (INSTI) is associated with a faster decline in HIV-RNA load than what is observed with regimens based on non-nucleoside transcriptase inhibitors (nnRTI), and protease inhibitors (PI). The clinical impact of this finding is unknown although clinical anecdotes suggest that it may it may cause a rapid decline in HIV RNA in women presenting with HIV in late pregnancy [5]. The objective of this study is to explore the impact of initiation of ART with different regimens in naïve MSM (in the setting of acute and chronic HIV-infection) on the probability of transmission of HIV by mathematical modeling.

Study Data Provided

Study VIIV-ING113086: A randomized, double blind study of the safety and efficacy of GSK1349572 50mg once daily to raltegravir 400mg twice daily both administered with fixed-dose dual nucleoside reverse transcriptase inhibitor therapy over 96 weeks in HIV-1 infected antiretroviral therapy naive adult subjects
Study VIIV-ING114467: A Randomized, Double-Blind Study of the Safety and Efficacy of GSK1349572 Plus Abacavir/Lamivudine Fixed-Dose Combination Therapy Administered Once Daily Compared to Atripla over 96 Weeks in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects
Study VIIV-ING114915: A Phase IIIb, randomized, open-label study of the safety and efficacy of GSK1349572 (dolutegravir, DTG) 50 mg once daily compared to darunavir/ritonavir (DRV/r) 800 mg/100 mg once daily each administered with fixed-dose dual nucleoside reverse transcriptase inhibitor therapy over 96 weeks in HIV-1 infected antiretroviral naïve adult subjects

Statistical Analysis Plan

The statistical analysis plan will be added after the research is published.

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.