Peripheral Reservoir of HIV DNA in Monocytes Pivotal to Cognition in HIV - Full Text View

Sponsored by:	South East Asia Research Collaboration with Hawaii
Information provided by:	South East Asia Research Collaboration with Hawaii
ClinicalTrials.gov Identifier:	NCT00782808

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

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Further study details as provided by South East Asia Research Collaboration with Hawaii:

Biospecimen Retention: Samples With DNA

Biospecimen Description:

-

Estimated Enrollment:	60
Study Start Date:	December 2008

Groups/Cohorts
1 PBMC HIV DNA level individuals will be stratified by high (more than or equal to 5000 copies/106 cells, n=30)
2 PBMC HIV DNA level individuals will be stratified by low (less than 5000 copies/106 cells, n=30).

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
Bangkok, Thailand

Sponsors and Collaborators

South East Asia Research Collaboration with Hawaii

Investigators

Principal Investigator:

Victor Valcour, MD

University of Hawii

More Information

Additional Information:

South East Asia Research Collaboration with Hawaii This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	( SEARCH ,Thai Red Cross AIDS Research Center,Bangkok,Thailand )
Study ID Numbers:	SEARCH 011
Study First Received:	October 29, 2008
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00782808 History of Changes
Health Authority:	Thailand: Ethical Committee

Keywords provided by South East Asia Research Collaboration with Hawaii:

HIV DNA in Monocytes

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on May 07, 2009