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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002107-15 | EudraCT Number |
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This substudy is a prospective, observational, open-label, randomised study within the MARCH study. The purpose of this substudy is to investigate the changes in cerebral function parameters at 5 timepoints over 96 weeks of the three different treatment arms within the MARCH study. The investigators hypothesise that there will be improvements in cerebral function in those patients randomised, as part of the parent study, into the maraviroc arms.
the assessments in this CNS substudy will include:
In those randomised to the maraviroc arms (arms 2 and 3) there is an optional Lumbar puncture at week 48. The cerebrospinal fluid will be used to measure maraviroc levels and an ultrasensitive CSF HIV-1 viral load. These results will be matched with levels in the plasma.
this is detailed above, this is a substudy of MARCH
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NRTI + PI | This is the randomisation of the main study, Arm 1 |
| |
| maraviroc + PI | this is the randomisation of the main study, Arm 2 |
| |
| maraviroc + NRTI | this is the randomisation of the main study, Arm 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm 1 TNucleotide Analogue Reverse Transcriptase Inhibitors and Boosted Protease Inhibitors | Drug | NRTI+PI |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess changes in NC function over 96 weeks, measured via a computerised testing battery in HIV-infected subjects stable on antiretroviral therapy randomised to three different treatment approaches | using CogState testing at 5 timepoints, weeks 0, 12, 24, 48, 96 | 96 weeks |
| To assess changes in cerebral metabolites over 96 weeks, measured via 1H Magnetic Resonance Spectroscopy (1H-MRS), in HIV-infected subjects stable on antiretroviral therapy randomised to three different treatment approaches | Assessment of CNS metabolites via 1H-MRS at week 0, 48, 96
| 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| to assess CSF HIV-1 RNA and CSF maraviroc concentration (in the MVC treatment arms) versus plasma HIV -1 RNA and MVC concentration after 48 weeks of therapy | A LP examination at week 48 (optional and only in the MVC treatment arms, and only if there is no contraindication to LP) to assess, with matched plasma samples:
| 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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participants in the MARCH main study who are eligible for the CNS substudy and provide written informed consent for participation
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| Name | Affiliation | Role |
|---|---|---|
| Alan Winston, MD | Imperial Healthcare, London, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundación IDEAA | Buenos Aires | Buenos Aires | C1405CKC | Argentina | ||
| Hospital Ramos MejÃa |
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plasma and CSF
| Arm 2 Maraviroc and Protease Inhibitors | Drug | maraviroc + PI |
|
|
| Arm 3 Maraviroc and Nucleotide Analogue Reverse Transcriptase Inhibitors | Drug | maraviroc + NRTI |
|
|
| Buenos Aires |
| C1221ADC |
| Argentina |
| CAICI | Rosario | Argentina |
| Chulalongkorn University Hospital | Bangkok | Bangkok | 10330 | Thailand |
| Brighton & Sussex University NHS Trust | Brighton | Sussex | BN21ES, | United Kingdom |
| Imperial Healthcare, St. Mary's Hospital | London | W2 | United Kingdom |
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D000068679 | Emtricitabine |
| D015215 | Zidovudine |
| D019259 | Lamivudine |
| C106538 | abacavir |
| D019438 | Ritonavir |
| D061466 | Lopinavir |
| D000069454 | Darunavir |
| D000069446 | Atazanavir Sulfate |
| C426859 | fosamprenavir |
| D011480 | Protease Inhibitors |
| D000077592 | Maraviroc |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D013936 | Thymidine |
| D015224 | Dideoxynucleosides |
| D016047 | Zalcitabine |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D011744 | Pyrimidinones |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D013450 | Sulfones |
| D005663 | Furans |
| D011725 | Pyridines |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D014230 | Triazoles |
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