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Pilot Project of Virologic and Immunologic Correlates of GALT Immune Reconstitution Following Raltegravir Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00661960
First received: April 16, 2008
Last updated: May 24, 2017
Last verified: May 2017
Results First Received: January 18, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: HIV Infections
AIDS
Interventions: Drug: raltegravir
Drug: efavirenz

  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
Subjects are recruited from the specialty clinic and their friends or family.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
no special pre-assignment details

Reporting Groups
  Description
Negative Volunteers HIV Negative volunteers
HIV-postive Randomized to Raltegravir HIV-Positive volunteers taking raltegravir in combination with two other nucleoside reverse transcriptase inhibitors (NRTI) medications
HIV-postive Randomized to NNRTI HIV-Positive volunteers taking efavirenz or any other non-nucleoside reverse transcriptase inhibitors (NNRTI) in combination with two other nucleoside reverse transcriptase inhibitor (NRTI) medications

Participant Flow:   Overall Study
    Negative Volunteers   HIV-postive Randomized to Raltegravir   HIV-postive Randomized to NNRTI
STARTED   5   10   10 
COMPLETED   5   7   9 
NOT COMPLETED   0   3   1 



  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
Negative Volunteers HIV Negative volunteers
HIV-postive Randomized to Raltegravir HIV-Positive volunteers taking raltegravir in combination with two other nucleoside reverse transcriptase inhibitors (NRTI) medications
HIV-postive Randomized to NNRTI HIV-Positive volunteers taking efavirenz or any other non-nucleoside reverse transcriptase inhibitors (NNRTI) in combination with two other nucleoside reverse transcriptase inhibitor (NRTI) medications
Total Total of all reporting groups

Baseline Measures
   Negative Volunteers   HIV-postive Randomized to Raltegravir   HIV-postive Randomized to NNRTI   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   10   10   25 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      5 100.0%      10 100.0%      10 100.0%      25 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 35  (5)   37  (5)   45  (5)   38  (5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      1  20.0%      4  40.0%      3  30.0%      8  32.0% 
Male      4  80.0%      6  60.0%      7  70.0%      17  68.0% 
Region of Enrollment 
[Units: Participants]
       
United States   5   10   10   25 


  Outcome Measures

1.  Primary:   the Percentage of CD3+/CD4+ Cells Per Cubic Millimeter at the Effector Sites in the Duodenal Tissues Obtained From Volunteers to the Antiretroviral Therapy Regimen Over Time.   [ Time Frame: nine months ]


  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
Limitations of the study include small numbers of subjects over all - Several subjects dropped out due to moving out of the region and lost to follow up.


  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: David Asmuth/Principal Investigator
Organization: UCaliforniaDavis
phone: 9167348695
e-mail: david.asmuth@ucdmc.ucdavis.edu


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00661960     History of Changes
Other Study ID Numbers: 200715792
Study First Received: April 16, 2008
Results First Received: January 18, 2013
Last Updated: May 24, 2017