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