Valganciclovir to Reduce T Cell Activation in HIV Infection

This study has been completed.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00264290
First received: December 9, 2005
Last updated: November 7, 2013
Last verified: November 2013
Results First Received: August 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV Infections
Cytomegalovirus Infections
Interventions: Drug: Valganciclovir
Drug: Placebo

  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
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
  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.
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  
Number of Participants  
[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.   Safety Issue:   No

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.   Safety Issue:   No

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.   Safety Issue:   No

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.   Safety Issue:   No

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.   Safety Issue:   No


  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
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Peter W. Hunt, M.D.
Organization: University of California, San Francisco
phone: 415-476-4082 ext 345
e-mail: phunt@php.ucsf.edu


Publications:
Publications automatically indexed to this study:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00264290     History of Changes
Other Study ID Numbers: H10775-26933-01, SFGH GCRC #976, 5 P30 AI 27763 - Hunt, Roche VAL 104
Study First Received: December 9, 2005
Results First Received: August 13, 2013
Last Updated: November 7, 2013
Health Authority: United States: Institutional Review Board