Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Kaiser Permanente HIV Cohort Study

This study has been completed.
Sponsor:
Collaborators:
Kaiser Permanente
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01339403
First received: March 16, 2011
Last updated: April 2, 2015
Last verified: April 2015
Results First Received: October 27, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: HIV
AIDS
Intervention: Other: non-interventional trial

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants infected and uninfected with Human Immunodeficiency Virus (HIV) were recruited and analyzed retrospectively in the Kaiser Permanente HIV registry.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cohort 1: HIV Infected Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
Cohort 2: HIV Uninfected Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).

Participant Flow:   Overall Study
    Cohort 1: HIV Infected   Cohort 2: HIV Uninfected
STARTED   24768   257600 
COMPLETED   24768   257600 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Analysis population included all participants enrolled in the study.

Reporting Groups
  Description
Cohort 1: HIV Infected Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
Cohort 2: HIV Uninfected Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
Total Total of all reporting groups

Baseline Measures
   Cohort 1: HIV Infected   Cohort 2: HIV Uninfected   Total 
Overall Participants Analyzed 
[Units: Participants]
 24768   257600   282368 
Age, Customized 
[Units: Participants]
     
Less than (<) 35 years   6883   76826   83709 
Between 35 and 39 years   4919   50657   55576 
Between 40 and 44 years   4700   47564   52264 
Between 45 and 49 years   3701   37184   40885 
Between 50 and 54 years   2302   22942   25244 
Between 55 and 59 years   1246   12199   13445 
Between 60 and 64 years   613   6154   6767 
Greater than (>) 65 years   404   4074   4478 
Gender 
[Units: Participants]
     
Female   2306   24134   26440 
Male   22462   233466   255928 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Incidence Rate of Malignancies   [ Time Frame: Up to Week 835 ]

2.  Primary:   Incidence Rate of Myocardial Infarction and Ischemia   [ Time Frame: Up to Week 835 ]

3.  Primary:   Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections   [ Time Frame: Up to Week 835 ]

4.  Primary:   Incidence Rate of Liver Failure   [ Time Frame: Up to Week 835 ]

5.  Primary:   Incidence Rate of Liver Related Death   [ Time Frame: Up to Week 835 ]

6.  Primary:   Incidence Rate of Rhabdomyolysis   [ Time Frame: Up to Week 835 ]

7.  Primary:   Incidence Rate of All-Cause Mortality   [ Time Frame: Up to Week 835 ]

8.  Primary:   Incidence Rate of Viral Encephalitis   [ Time Frame: Up to Week 730 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
Designation of endpoints was based on study team's inputs, as the endpoints were not prioritized in the study protocol.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01339403     History of Changes
Other Study ID Numbers: A4001105
Study First Received: March 16, 2011
Results First Received: October 27, 2014
Last Updated: April 2, 2015
Health Authority: United States: Food and Drug Administration