Peripheral Reservoir of HIV DNA in Monocytes Pivotal to Cognition in HIV
This study is currently recruiting participants.
Verified October 2008 by South East Asia Research Collaboration with Hawaii
Sponsor:
South East Asia Research Collaboration with Hawaii
Collaborator:
Information provided by:
South East Asia Research Collaboration with Hawaii
ClinicalTrials.gov Identifier:
NCT00782808
First received: October 29, 2008
Last updated: July 21, 2011
Last verified: October 2008
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Purpose
Sixty HIV participants will be enrolled and stratified by PBMC HIV DNA levels, either high (greater than or equal to 5000 copies/106 cells) or low (less than 5000 copies/106 cells). Individuals will be enrolled into each group until filled. Screening PBMC HIV DNA levels will be performed at SEARCH in real-time with less than one-week turn around time. All individuals will intend to initiate ARV due to meeting MOPH guidelines for such. The protocol team will work with the primary care physician to facilitate initiation of standard ARV care; however, initiation of ARV is not a requirement of the study and ARV will not be provided by the study.
| Condition |
|---|
|
HIV Infections |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Deoxyribonucleic acid
U.S. FDA Resources
Further study details as provided by South East Asia Research Collaboration with Hawaii:
| Estimated Enrollment: | 52 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | March 2016 |
| Groups/Cohorts |
|---|
| 1 HIV DNA will be stratified by high |
| 2 HIV DNA will be stratified by low |
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
HIV-infected individuals meeting MOPH criteria to initiate HAART and planning to initiate HAART within a month of screening. Consequently, all participants will have plasma CD4 counts at less than 250 cells.
Criteria
Inclusion Criteria:
- HIV-infected individuals meeting MOPH criteria to initiate HAART and planning to initiate HAART within a month of screening.
- Consequently, all participants will have plasma CD4 counts at less than 250 cells.
Exclusion Criteria:
- Head injury with loss of consciousness greater than 1 hour or cognitive sequela
- Current/past illicit drug use or positive drug screen for methamphetamines, amphetamines, or cocaine at screening or entry.
Any of the following laboratory abnormalities:
- PT/PTT > the upper limit of normal (ULN) or INR > 1.1
- Hemoglobin < 9.0 mg/dL
- ALT > 5x ULN
- serum creatinine > 2x ULN or creatinine clearance < 30 cc per min by Cockroft-Gault formula
- Acute illness within 30 days prior, persistent and active AIDS-defining OI of any organ system or autoimmune disease.
- Current or recent fevers or meningeal signs suggestive of CNS opportunistic infection
- CNS opportunistic infection, past or present (Patients diagnosed with opportunistic infection after CSF examination will be excluded from further analysis. In such a situation, an additional patient will be enrolled)
- History of pre-existing neurologic disease to include stroke, multiple sclerosis or psychiatric illness including schizophrenia, bipolar disorder, anxiety disorder, panic attacks, major depression, or post traumatic stress disorder. Patients with past depression that is controlled and patients with or minor depressive symptoms will be allowed to enroll.
- Known learning disability including dyslexia or unable to read or write basic Thai
- Positive Hepatitis C serology (Hepatitis C Ab)
- Confusion or other signs and symptoms of metabolic encephalopathy or delirium
- Other conditions that could explain neurocognitive decline in the opinion of the investigator such as hypothyroidism, vitamin B12 deficiency or neurosyphilis
- Pregnancy or metal objects that would preclude MRI
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00782808
Contacts
| Contact: Jintanat Ananworanich, MD | 662-254-2566 ext 101 | jintanat.a@searchthailand.org |
| Contact: somprartthana Rattanamanee, RN | 662-254-2566 ext 106 | somprartthana.r@searchthailand.org |
Locations
| Thailand | |
| SEARCH Thailand | Recruiting |
| Bangkok, Thailand | |
| Contact: Somprartthana Rattanamanee, RN 662-254-2566 ext 106 somprartthana.r@searchthailand.org | |
Sponsors and Collaborators
South East Asia Research Collaboration with Hawaii
Investigators
| Principal Investigator: | Victor Valcour, MD | University of Hawii |
More Information
Additional Information:
No publications provided
| Responsible Party: | Victor Valcour, MD, Memory and Aging Center, UCSF |
| ClinicalTrials.gov Identifier: | NCT00782808 History of Changes |
| Other Study ID Numbers: | SEARCH 011 |
| Study First Received: | October 29, 2008 |
| Last Updated: | July 21, 2011 |
| Health Authority: | Thailand: Ethical Committee |
Keywords provided by South East Asia Research Collaboration with Hawaii:
|
HIV DNA in Monocytes |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 16, 2013