Assessment of the HIV CNS Reservoir, Neurological and Neuro-cognitive Effects, and Source of Rebound HIV in CNS
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02470351 |
Recruitment Status :
Completed
First Posted : June 12, 2015
Last Update Posted : April 26, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Acute HIV Infection HIV CNS Involvement |

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 |
- 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 ]
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

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
Thailand | |
SEARCH Thailand | |
Bangkok, Thailand, 10330 |
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 |
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 |
HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |