Trial record 16 of 31 for:    " July 12, 2011":" August 11, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Stanford Universities: The Stanford HIV Aging Cohort

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01401348
First received: July 19, 2011
Last updated: July 22, 2011
Last verified: July 2011
  Purpose

A research study to evaluate the effect of aging and HIV on neurocognitive dysfunction (declining ability to process information), physical frailty and heart disease. HIV-infected participants whose virus is controlled on antiretroviral medications will be studied to determine the rates and risk factors of developing these conditions.


Condition
Acquired Immunodeficiency Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Stanford HIV Aging Cohort (SHAC)

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • neurocognitive testing [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Controlled oral word association test-FAS, Paced auditory serial addition task, trail making a and b, REY auditory verbal learning test, grooved peg board, timed gait


Secondary Outcome Measures:
  • cardiovascular testing [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
    ankle-brachial index


Biospecimen Retention:   Samples Without DNA

PBMC's


Estimated Enrollment: 300
Study Start Date: December 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Detailed Description:

With advances in antiretroviral therapy, the life expectancy of HIV-infected individuals continues to improve with older individuals representing a rapidly growing proportion of those infected. However, despite improved life expectancy, substantial residual morbidity remains in treated HIV including increased rates of neurocognitive dysfunction, frailty, and cardiovascular disease. As these conditions also increase with normal aging, HIV is often thought to be a risk factor for "early" or "accelerated" aging. Prior studies have generally focused on HIV-specific factors and risk for neurocognitive dysfunction, frailty, and cardiovascular disease, while few have examined extensively risk factors found to be significant for these conditions in the general population.

The investigators hypothesize that the effects of age and HIV will be synergistic on the rates of non-AIDS morbidity. While the correlates and risk factors for non-AIDS morbidity in younger individuals may largely be related to HIV, in older individuals with sustained virologic control, traditional risk factors for neurocognitive disease, frailty, and cardiovascular disease will contribute more significantly to disease than HIV-specific risk factors. Our primary objectives are to:

  1. Define the prevalence and incidence of neurocognitive dysfunction, frailty, and cardiovascular disease in a well-defined cohort of aging virologically suppressed HIV-infected individuals.
  2. Identify correlates and risk factors for prevalent and incident neurocognitive dysfunction, frailty, and cardiovascular disease.
  3. Compare and contrast the identified correlates and risk factors for the co-morbidities of interest in older (>50 years old) and younger HIV-infected individuals.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

300 HIV-infected participants whose virus is controlled on antiretroviral medications from the Stanford Positive Care Clinic. Five (150) patients over 50 years old and five (150) patients less than 50 years old

Criteria

Inclusion Criteria:

  • Subjects must have an HIV RNA level below the limit of quantification (e.g., <75 copies, <50 copies, or <48 copies/mL, depending on the assay used) for at least 6 months excluding "blips" (e.g., a single measurement between 48-200 copies/mL preceded and followed by measurements below the limit of quantification) while on antiretroviral therapy.

Exclusion Criteria:

  1. Completed treatment for any acute systemic infection (other than HIV-1) less than four weeks before study entry.
  2. Any active brain infection (except for HIV-1), brain neoplasm, or space-occupying brain lesion.
  3. Receipt of immunomodulating medication (e.g., corticosteroids, immunoglobulin, etc.) within four weeks of study entry.
  4. Any active psychiatric illness including schizophrenia, severe depression, or severe bipolar affective disorder that, in the opinion of the investigator, could confound the analysis of the neuropsychological test results.
  5. Active drug or alcohol abuse that, in the investigator's opinion, could prevent compliance with study procedures or confound the analysis of study endpoints.
  6. Unable to provide informed consent
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01401348

Contacts
Contact: Debbie Slamowitz (650) 723-2804 dslam@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Debbie Slamowitz    650-723-2804    dslam@stanford.edu   
Contact: Stacy Kobayashi    (650) 723-2805    stacyk@stanford.edu   
Principal Investigator: Philip Grant         
Principal Investigator: Andrew R Zolopa         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Andrew R Zolopa Stanford University
Principal Investigator: Philip Grant Stanford University
  More Information

No publications provided

Responsible Party: Andrew R Zolopa, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01401348     History of Changes
Other Study ID Numbers: SU-12142010-7318
Study First Received: July 19, 2011
Last Updated: July 22, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014