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

NCT01367236 | Completed Phase 4 Results DMC

• 2 other identifiers: 17332011-002656-14
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

HIV; Impaired Cognition

Keywords

HIV

Outcome Measures

Primary Outcomes (1)

• Cognitive Function, Global Cognitive Score (Z-score)

  When commencing antiretroviral therapy (anti-HIV therapy) for the first time, improvements in the function of the brain are frequently observed. For example memory and concentration may improve. However, whether these improvements may differ between different anti-HIV therapies is largely unknown. 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. Score increase means improved performance of cognitive function

  24 weeks, 48 weeks

Secondary Outcomes (1)

• Brain Function, Absolute Change Over 48 Weeks of N-acetyl Aspartate/Creatinine Ratio

  48 weeks

Study Arms (2)

standard care

ACTIVE COMPARATOR

treatment with: * atazanavir 300 mg daily * ritonavir 100 mg daily * tenofovir 245 mg daily\* * emtricitabine 200 mg daily\* \* as the fixed dose combination Truvada™

Drug: standard care

Novel therapeutic approach

ACTIVE COMPARATOR

* darunavir 800 mg daily * ritonavir 100 mg daily * lamivudine 300 mg daily\*\* * abacavir 600 mg daily\*\* * maraviroc 150 mg once daily \*\* as the fixed dose combination Kivexa ™

Drug: novel treatment

Interventions

standard care DRUG

* atazanavir 300 mg daily * ritonavir 100 mg daily * tenofovir 245 mg daily\* * emtricitabine 200 mg daily\*

standard care

novel treatment DRUG

* darunavir 800 mg daily * ritonavir 100 mg daily * lamivudine 300 mg daily\*\* and abacavir 600mgs daily\*\* * maraviroc 150 mg once daily

Novel therapeutic approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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\*

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• Pfizer: collaborator

Study Sites (6)

Birmingham Heartlands Hospital:

Birmingham, United Kingdom

Location

Brighton and Sussex University Hospital NHS Trust:

Brighton, BN1 9RE, United Kingdom

Location

Kings College Hospital

London, SE5 9RJ, United Kingdom

Location

Chelsea and Westminster Hospital NHS Trust

London, SW10 9NH, United Kingdom

Location

St. Mary's Hospital

London, W2 1NY, United Kingdom

Location

St. Thomas' Hospital

London, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 29438199 RESULT

MeSH Terms

Conditions

Cognition Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Professor Alan Winston
• Organization: Imperial College London

a.winston@imperial.ac.uk

+44 (0)20 3312 1603

Study Officials

• Alan Winston

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2011
• First Posted: June 7, 2011
• Study Start: January 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 21, 2019
• Results First Posted: October 21, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (6)