Overview

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

Status:
Completed
Trial end date:
2015-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Imperial College London
Collaborator:
Pfizer
Treatments:
Atazanavir Sulfate
Darunavir
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Maraviroc
Ritonavir
Criteria
Inclusion Criteria:

- HIV-1 infected males or females

- signed informed consent

- no previous antiretroviral treatment since HIV diagnosis

- screening CD4+ lymphocyte count <= 350 cells/ųL

- susceptible to all currently licensed (Nucleoside Reverse Transcriptase Inhibitors)
NRTIs, (Non-Nucleoside Reverse Transcriptase Inhibitors) NNRTIs and PIs based on HIV-1
genotypic resistance report

- CCR5-tropic HIV based on genotypic resistance testing*

Exclusion Criteria:

- • existing neurological disease

- hepatitis B or hepatitis C co-infection

- age under 18 years

- screening laboratory parameters > grade 2 (with the exception of cholesterol and
triglycerides)

- current history of major depression or psychosis

- recent head injury (past three months)

- current alcohol abuse or drug dependence

- active opportunistic infection or significant co-morbidities

- patients who are receiving other concomitant medication which are not permitted,
as listed in appendix 2

- female patients of child-bearing potential who:

- have a positive serum pregnancy test at screening or during the study

- are breast feeding

- are planning to become pregnant

- all participants unwilling to use a barrier method of contraception

- patients who in the opinion of the investigator are not candidates for inclusion
in the study