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Valganciclovir to Reduce T Cell Activation in HIV Infection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00264290
First Posted: December 12, 2005
Last Update Posted: December 3, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
University of California, San Francisco
Results First Submitted: August 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV Infections
Cytomegalovirus Infections
Interventions: Drug: Valganciclovir
Drug: Placebo

  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
Cytomegalovirus (CMV)-seropositive adults with chronic HIV infection were recruited at one US clinical site.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 60 screened subjects, 3 refused participation and 27 did not meet eligibility criteria. The most common reason for exclusion was <10% activated Cluster of differentiation * (CD8)+ T cells.

Reporting Groups
  Description
Placebo Placebo PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone.
Valganciclovir

900mg PO qd

Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone.


Participant Flow for 2 periods

Period 1:   Intervention (8 Weeks)
    Placebo   Valganciclovir
STARTED   16   14 
COMPLETED   15   14 
NOT COMPLETED   1   0 
Adverse Event                1                0 

Period 2:   Observation (4 Weeks)
    Placebo   Valganciclovir
STARTED   15   14 
COMPLETED   15   14 
NOT COMPLETED   0   0 



  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
Placebo Placebo PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.
Valganciclovir

900mg PO qd

Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.

Total Total of all reporting groups

Baseline Measures
   Placebo   Valganciclovir   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   14   30 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   16   14   30 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Full Range)
 50 
 (44 to 59) 
 48 
 (43 to 55) 
 49 
 (43 to 59) 
Gender 
[Units: Participants]
     
Female   0   2   2 
Male   16   12   28 
Region of Enrollment 
[Units: Participants]
     
United States   16   14   30 


  Outcome Measures

1.  Primary:   Change in %CD38+ Human Leukocyte Antigen-D-related (HLA-DR)+ CD8+ T Cells From Baseline to Week 8.   [ Time Frame: Baseline, 8 weeks ]

2.  Secondary:   Change in CMV DNA Shedding From Baseline to Week 8.   [ Time Frame: week 8 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Change in Cluster of Differentiation 4 (CD4) Counts and Plasma HIV RNA Levels at Week 8.   [ Time Frame: week 8 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   %CD38+HLA-DR+ CD8+ T Cells After a 4-week Washout Period   [ Time Frame: Week 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Change in CMV DNA Shedding After a 4-week Washout Period   [ Time Frame: Week 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Change in CD4 Counts and Plasma HIV RNA Levels After a 4-week Washout Period   [ Time Frame: Week 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events
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Time Frame 8 weeks of study treatment and a 4-week washout period
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Placebo Placebo PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.
Valganciclovir

900mg PO qd

Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.


Other Adverse Events
    Placebo   Valganciclovir
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   0/16 (0.00%)   0/14 (0.00%) 



  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
No text entered.


  More Information