Efficacy of switch to lopinavir/ritonavir in improving cognitive function in efavirenz treated patients

Phase 4

Completed

• Conditions: Infectious diseases and microbiology; Infections and Infestations

• Registration Number: ISRCTN73411795
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Brief Summary

1. 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27132696 2. 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/29054815

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-16
• Study Completion: 2015-11-27
• Last Update Posted: 8 April 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Documented HIV-1 viral load (VL) measurement =200 copies/ml within 4 months preceding study entry and no VL exceeding 200c/ml within 1 year prior to study entry. The constraint of >1 year of HIV infection is to remove any CNS effects of acute retroviral syndrome.
2. Documented HIV-1 RNA viral load (VL) measurement of <50 copies/ml within the 4 months preceding study entry and no VL exceeding 200c/ml within 1year prior to study entry. This constraint is to remove any CNS effects of active viral replication at baseline, and / or potential change in level of viral replication during the study period.
3. On HAART (at least 3 anti-retroviral drugs from at least 2 classes) for at least 12 months prior to study entry.
4. On Efavirenz (EFV, Sustiva) for at least 6 months prior to study entry. This constraint is to remove acute neuropsychiatric effects of EFV which are typically clinically apparent in the first 4-6 weeks of therapy.
5. Patient has provided written informed consent for participation in the study prior to any study specific procedures
6. Age 18 to 65 years inclusive
7. Male and female participants

Exclusion Criteria

1. Use of Kaletra or any other HIV protease inhibitor within 6 months of study entry
2. Current self-reported (within last 3 months) recreational drug use
3. Current self-reported weekly alcohol consumption exceeding 35 units/week
4. Known contra-indication to MRI scanning
5. Known hypersensitivity to Kaletra, or to ritonavir in pharmacokinetic boosting doses (100 or 200mg ritonavir daily)
6. Currently (within 6 weeks of study entry) receiving interferon therapy for treatment of chronic viral hepatitis, or expected to commence such treatment with the next 4 months
7. Severe renal or hepatic impairment;
8. Pregnancy, or women planning to become pregnant within next 6 months;
9. Women breastfeeding
10. Use of other investigational study drugs within 30 days prior to study entry (defined as date of randomisation into study)
11. Previous participation in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in cognitive test scores from visit 1 (baseline) to visit 3 (10 weeks from switch to Kaletra)

Secondary Outcome Measures

Name	Time	Method
<br> 1. Change in resting-state and attentional processing task-based fMRI<br> 2. Change in sleep quality<br> 3. Change in cerebral metabolite profile on magnetic resonance spectroscopy<br> All outcomes measured from visit 1 (baseline) to visit 3 (10 weeks from switch to Kaletra)<br>