Switching from efavirenz/tenofovir/emtricitabine (TDF/FTC/EFV) to abacavir/lamivudine/maraviroc (ABC/3TC/MVC) to assess antiretroviral activity in cerebrospinal fluid
- Conditions
- Human immunodeficiency virus (HIV)Infections and Infestations
- Registration Number
- ISRCTN08592155
- Lead Sponsor
- Institute of Biomedical Investigations of Bellvitge [Institut d'Investigació Biomèdica de Bellvitge (IDIBELL)] (Spain)
- Brief Summary
1. 2015 results in https://www.ncbi.nlm.nih.gov/pubmed/25721471 (added 21/01/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 15
1. Human immunodeficiency virus positive (HIV+)
2. Adults aged over 18 years
3. HLA-B*57:01:01 negative
4. On TDF/FTC/EFV treatment for at least 24 weeks and undetectable HIV viral load in the last 24 weeks
5. Neurocognitive impairment
6. CCR5+ (pro-viral deoxyribonucleic acid [DNA])
7. Signed informed consent
1. Alanine aminotransferase (ALT) greater than 5 fold upper normal limit
2. Renal impairment (creatinine clearance [Cl cr] less than 50 ml/min)
3. Haemoglobin less than 9 g/dl
4. Neutropenia (PMN) less than 1000/ml
5. Platelets less than 30,000/mm3
6. Opportunistic infection, cancer and /or any disease which could alter blood brain barrier permeability (meningitis, cancer, etc.)
7. Neuro-psychiatric disease (previous or current)
8. Illicit drugs use
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Viral load (VL) less than 5 copies/ml in CSF, evaluated at week 48
- Secondary Outcome Measures
Name Time Method <br> Evaluated at week 48:<br> 1. Viral load (VL) less than 50 copies/ml in CSF<br> 2. Central nervous system (CNS) inflammatory markers change in CSF<br> 3. Neurocognitive tests<br>