Aging & HIV/AIDS Neurocognitive Sequelae and Functional Consequences

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00675766
First received: May 7, 2008
Last updated: April 29, 2015
Last verified: April 2015
Results First Received: February 13, 2015  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Prospective
Condition: HIV Infections

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment took place from September 2005 to September 2010. The population consisted of young (40 years or less) and old (50 years or more) Human Immunodeficiency Virus infected and non-infected veterans within the Greater Los Angeles VA Healthcare System with additional recruitment from the Los Angeles community in order to meet project goals.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Recruited subjects who meet any of the following criteria were excluded prior to group assignment: Brain infection other than HIV; Brain neoplasm; neurosyphilis; traumatic brain injury with L.O.C>30 mins; current diagnosis of seizure disorder; current psychotic spectrum disorders; history of drug or alcohol abuse or dependence within the past year.

Reporting Groups
  Description
Group 1 HIV-positive adults 50 and older
Group 2 HIV-positive adults 18-40 years old
Group 3 HIV-negative controls 50 and older
Group 4 HIV-negative controls 18-40 years old

Participant Flow:   Overall Study
    Group 1     Group 2     Group 3     Group 4  
STARTED     106     30     50     37  
Year 2     105     28     34     20  
Year 3     100     25     29     11  
COMPLETED     100     25     29     11  
NOT COMPLETED     6     5     21     26  
Lost to Follow-up                 6                 5                 21                 26  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group 1 HIV-positive adults 50 and older
Group 2 HIV-positive adults 18-40 years old
Group 3 HIV-negative controls 50 and older
Group 4 HIV-negative controls 18-40 years old
Total Total of all reporting groups

Baseline Measures
    Group 1     Group 2     Group 3     Group 4     Total  
Number of Participants  
[units: participants]
  106     30     50     37     223  
Age, Customized  
[units: participants]
         
Between 18 and 40 years old     0     30     0     37     67  
50 years and older     106     0     50     0     156  
Gender  
[units: participants]
         
Female     18     6     32     17     73  
Male     88     24     18     20     150  
Race (NIH/OMB)  
[units: participants]
         
American Indian or Alaska Native     2     0     2     0     4  
Asian     1     1     1     3     6  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0  
Black or African American     59     12     36     16     123  
White     43     15     9     12     79  
More than one race     1     2     2     6     11  
Unknown or Not Reported     0     0     0     0     0  
Region of Enrollment  
[units: participants]
         
United States     106     30     50     37     223  



  Outcome Measures

1.  Primary:   Neuropsychological Status (i.e., Cognitive Functioning)   [ Time Frame: Baseline (Year 1) and 1-year follow-up (Year 2) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Large number of subjects who were lost to follow up (i.e moved from community, did not answer follow up calls to schedule visits) resulted in a reduced sample size of subjects who completed the study.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Charles Hinkin
Organization: West Los Angeles Veterans Association
phone: 310-478-3711 ext 44214
e-mail: chinkin@ucla.edu


No publications provided by Department of Veterans Affairs

Publications automatically indexed to this study:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00675766     History of Changes
Other Study ID Numbers: AGCG-012-04F
Study First Received: May 7, 2008
Results First Received: February 13, 2015
Last Updated: April 29, 2015
Health Authority: United States: Federal Government