Changes in Cerebral Function in Treatment Naive HIV-1 Infected Subjects Commencing Either Boosted Atazanavir With Truvada or Boosted Darunavir With Maraviroc and Kivexa

Summary

The purpose of this study is to compare two different combination anti-HIV therapies over 48 weeks and to assess if differences in improvement in the function of the brain are observed over this period. The study will compare anti-HIV therapy combinations which are currently in use. The patients will not have had any previous treatment for their HIV infection.

Timeline

Start

2013-01

Primary completion

2015-10

Completion

2015-10

Outcome

Missed primary endpoint

registry analysis (superiority test); Standard Boosted vs Maraviroc-intesified Boosted; p = 0.68; Regression, Linear NCT01367236 ↗

paper Maraviroc-intensified ART had no demonstrable benefit on cognitive function in individuals initiating ART. PMID 29438199 ↗

Publications

• Results Mora-Peris B, Bouliotis G, Ranjababu K, Clarke A, Post FA, Nelson M, Burgess L, Tiraboschi J, Khoo S, Taylor S, Ashby D, Winston A. Changes in cerebral function parameters with maraviroc-intensified antiretroviral therapy in treatment naive HIV-positive individuals. AIDS. 2018 May 15;32(8):1007-1015. doi: 10.1097/QAD.0000000000001786.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abacavir	Other / unclassified	600 mg	—
Subject	Atazanavir	Other / unclassified	300 mg	—
Subject	Darunavir	Small molecule	800 mg	—
Subject	Lamivudine	Other / unclassified	300 mg	—
Subject	Maraviroc	Other / unclassified	150 mg	—
Subject	Tenofovir	Small molecule	245 mg	—
Subject	emtricitabine	Other / unclassified	200 mg	—
Background	Ritonavir	Other / unclassified	100 mg	—

Indications