Assessment of the HIV CNS Reservoir, Neurological and Neuro-cognitive Effects, and Source of Rebound HIV in CNS
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| ClinicalTrials.gov Identifier: NCT02470351 |
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Recruitment Status :
Completed
First Posted : June 12, 2015
Last Update Posted : April 26, 2016
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Sponsor:
South East Asia Research Collaboration with Hawaii
Collaborator:
US NIH Research Project Grant Program
Information provided by (Responsible Party):
Nittaya Phanuphak, MD, PhD, South East Asia Research Collaboration with Hawaii
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Brief Summary:
This study aims to describe in depth the CNS, CNS HIV reservoir and CNS viral rebound in consenting SEARCH 019 subjects prior to, during and after the SEARCH 019 study intervention (VHM + ART or ART only), at 1) baseline, 2) end of study intervention and start of ART interruption, 3) viral rebound (if occurring) or mid-way during observed ART interruption, and 4) at the end of ART interruption. Study SEARCH 026 itself does not employ any therapeutic interventions. However, consenting subjects will participate in lumbar puncture, non-contrast MRI + MRS, and neuropsychological testing at at least three and at most four time points. Any of the 15 subjects to be enrolled in SEARCH 019 may consent to study SEARCH 026 participation and hence a maximum of 15 subjects may enroll. As this is a sub-study, data will be shared from study SEARCH 019 and no interventions (venipunctures) will be repeated unnecessarily.
| Condition or disease |
|---|
| Acute HIV Infection HIV CNS Involvement |
Show Detailed Description
| Study Type : | Observational |
| Actual Enrollment : | 9 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Study SEARCH 026Assessment of the HIV CNS Reservoir, Neurological and Neuro-cognitive Effects, and Source of Rebound HIV in CNS in Subjects Participating in Study SEARCH 019 |
| Study Start Date : | January 2015 |
| Actual Primary Completion Date : | November 2015 |
| Actual Study Completion Date : | March 2016 |
Primary Outcome Measures :
- CSF vs. plasma HIV viral load in VHM+ART and ART alone [ Time Frame: 34 weeks ]Difference between CSF vs. plasma HIV viral load in VHM+ART and ART alone groups at study baseline (prior to VHM initiation), at time just before ATI, midway through ATI period (if not preceded by viral rebound) and at viral rebound or end of ATI observation period. Unit of measure: copies/mL.
- Establishment of HIV in the CNS and the source of resurgent CSF HIV RNA between plasma and CSF variants prior to ART and after VHM intervention. [ Time Frame: 34 weeks ]
Secondary Outcome Measures :
- Change in levels over time of CSF neopterin (nmol/L), sCD14 (ng/mL), CSF MCP-1 (pg/dL), IP-10 (nmol/L), sCD163 (ng/mL), IL-6 (pg/mL), and HIV RNA (copies/mL) value by single copy assay [ Time Frame: 34 weeks ]
- Change over time in appearance of structural and T2 MRI scans including evidence of neuroinflammatory lesions [ Time Frame: 34 weeks ]
- Change over time in concentrations of creatine (Cr) of choline (Cho), myoinositol (mI), and n-acetylaspartate (NAA) in the basal ganglia, occipital grey matter, and frontal white matter. Unit of measure of all metabolites is mM. [ Time Frame: 34 weeks ]
- Measurement ratios with respect to creatinine (Cr) of choline (Cho), myoinositol (mI), and n-acetylasparate (NAA) in the basal ganglia, occipital grey matter, and frontal white matter. Unit of measure for all metabolites is mM. [ Time Frame: 34 weeks ]
- Change over time in measures of fractional anisotropy on diffusion tensor imaging (DTI) in whole brain and voxel-based analysis [ Time Frame: 34 weeks ]
- Measurement of mean diffusivity on diffusion tensor imaging (DTI) in whole brain and voxel based analysis. [ Time Frame: 34 weeks ]
- Change over time in patterns of functional MRI activity between major brain networks [ Time Frame: 34 weeks ]
- Change over time in performance on neuropsychological test battery [ Time Frame: 34 weeks ]
Biospecimen Retention: Samples With DNA
HIV RNA standard quantitation will be completed using the Roche COBAS/Amplicor HIV-1 Viral Load v2.0 assay, with a lower limit of quantitation of 20cps/mL. Single Copy Assay (SCA) HIV RNA quantitation in the setting of ART will be performed using 5-10 ml of CSF. In addition, cell associated HIV-DNA (total, integrated and 2LTR circles in total CD4+ T cells will be assessed at CRC-CHUM.
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| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Any of the 15 subjects to be enrolled in SEARCH 019 may consent to study SEARCH 026 participation and hence a maximum of 15 subjects may enroll.
Criteria
Inclusion Criteria:
- Volunteers recruited to participate in this study must satisfy all of the inclusion and exclusion criteria for study SEARCH 019.
Exclusion Criteria:
- Subject is pregnant or breast-feeding.
- Any contraindication to lumbar puncture, such as history of bleeding diathesis or known cerebral mass lesion
- Any contraindication to MRI or MRS such as an implanted pacemaker, some older intracranial aneurysm clips, cochlear implants, certain prosthetic devices, implanted drug infusion pumps, neurostimulators, bone-growth stimulators, certain intrauterine contraceptive devices, or any other type of iron-based metal implants. MRI is also contraindicated in the presence of some internal metallic objects such as bullets or shrapnel, as well as most surgical clips, pins, plates, screws, metal sutures, or wire mesh.
- Subject has been diagnosed with a serious medical or psychiatric illness that, in the opinion of the site investigator, would interfere with his or her ability to adhere to study requirements or to give informed consent.
- Subject has active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with his or her ability to adhere to study requirements or to give informed consent.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470351
Locations
| Thailand | |
| SEARCH Thailand | |
| Bangkok, Thailand, 10330 | |
Sponsors and Collaborators
South East Asia Research Collaboration with Hawaii
US NIH Research Project Grant Program
Investigators
| Principal Investigator: | Nittaya - Phanuphak, MD, PhD | South East Asia Research Collaboration with Hawaii |
| Responsible Party: | Nittaya Phanuphak, MD, PhD, South East Asia Research Collaboration with Hawaii |
| ClinicalTrials.gov Identifier: | NCT02470351 History of Changes |
| Other Study ID Numbers: |
SEARCH 026 |
| First Posted: | June 12, 2015 Key Record Dates |
| Last Update Posted: | April 26, 2016 |
| Last Verified: | March 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
Additional relevant MeSH terms:
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HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |