Infection, Human Immunodeficiency Virus

ACC017 is an integrase inhibitor that will be evaluated for the treatment of HIV infection. This phase Ib/IIa, randomized, double-blind, parallel, dose ranging, placebo-controlled 'proof of concept' study is designed to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of ACC017 monotherapy and combined with FTC/TAF by sequency versus placebo in treatment-naïve HIV-1 infected adults. This study includes two stages, stage one is a single dose escalation, and all subjects will be co-administrated with FTC/TAF at 200 mg/25 mg on stage two. The study consists of a screening visit, baseline period, monotherapy period, and combination therapy period. Total 36 subjects will be randomized in a 5:1 ratio to receive one of three doses of ACC017 or placebo lasting for 10 days for monotherapy followed by 18 days for combination therapy.

The goal of this compassionate use program is to provide a mechanism to supply Cabotegravir, CAB on an individual named patient basis for treatment of individuals who have no available treatment alternatives and/or limited treatment options (e.g., who are unable to participate in the Phase III clinical studies or do not qualify), and are in need of new drugs to construct an effective antiviral regimen and may require the use of parenterally administered drug given underlying medical conditions. You can access ViiV's Policy on Compassionate via https://us.viivhealthcare.com/media/124424/viivs-external-policy-on-cup\_final-version\_23feb2017.pdf.