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Trial record 16 of 102 for:    Valcyte

Valganciclovir to Reduce T Cell Activation in HIV Infection

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.
ClinicalTrials.gov Identifier: NCT00264290
Recruitment Status : Completed
First Posted : December 12, 2005
Results First Posted : November 8, 2013
Last Update Posted : December 3, 2013
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
University of California, San Francisco

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
Enrollment 30
Recruitment Details Cytomegalovirus (CMV)-seropositive adults with chronic HIV infection were recruited at one US clinical site.
Pre-assignment Details 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.
Arm/Group Title Placebo Valganciclovir
Hide Arm/Group Description Placebo PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone.

900mg PO qd

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

Period Title: Intervention (8 Weeks)
Started 16 14
Completed 15 14
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Period Title: Observation (4 Weeks)
Started 15 14
Completed 15 14
Not Completed 0 0
Arm/Group Title Placebo Valganciclovir Total
Hide Arm/Group Description Placebo PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.

900mg PO qd

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

Total of all reporting groups
Overall Number of Baseline Participants 16 14 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
 100.0%
14
 100.0%
30
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 16 participants 14 participants 30 participants
50
(44 to 59)
48
(43 to 55)
49
(43 to 59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
Female
0
   0.0%
2
  14.3%
2
   6.7%
Male
16
 100.0%
12
  85.7%
28
  93.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 14 participants 30 participants
16 14 30
1.Primary Outcome
Title Change in %CD38+ Human Leukocyte Antigen-D-related (HLA-DR)+ CD8+ T Cells From Baseline to Week 8.
Hide Description The percentage of activated (CD38+ HLA-DR+) CD8+ T cells was measured on fresh whole blood at screening/baseline. T cell activation was measured on peripheral blood mononuclear cells (PBMCs)in batch at the end of the study.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Valganciclovir
Hide Arm/Group Description:
placebo PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.

900mg PO qd

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

Overall Number of Participants Analyzed 15 14
Mean (95% Confidence Interval)
Unit of Measure: percentage of activated T cells
1.3
(-2.6 to 5.8)
-4.0
(-5.7 to -0.9)
2.Secondary Outcome
Title Change in CMV DNA Shedding From Baseline to Week 8.
Hide Description Change in percentage of participants with detectable CMV DNA. Herpesvirus DNA levels were assessed by polymerase chain reaction (lower limit of detection, 150 copies/mL) on saliva and seminal plasma.
Time Frame week 8
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Change in Cluster of Differentiation 4 (CD4) Counts and Plasma HIV RNA Levels at Week 8.
Hide Description [Not Specified]
Time Frame week 8
Outcome Measure Data Not Reported
4.Secondary Outcome
Title %CD38+HLA-DR+ CD8+ T Cells After a 4-week Washout Period
Hide Description [Not Specified]
Time Frame Week 12
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Change in CMV DNA Shedding After a 4-week Washout Period
Hide Description [Not Specified]
Time Frame Week 12
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Change in CD4 Counts and Plasma HIV RNA Levels After a 4-week Washout Period
Hide Description [Not Specified]
Time Frame Week 12
Outcome Measure Data Not Reported
Time Frame 8 weeks of study treatment and a 4-week washout period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Valganciclovir
Hide Arm/Group Description Placebo PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.

900mg PO qd

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

All-Cause Mortality
Placebo Valganciclovir
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Valganciclovir
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/16 (6.25%)      0/14 (0.00%)    
Cardiac disorders     
congestive heart failure   1/16 (6.25%)  1 0/14 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Valganciclovir
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/14 (0.00%)    
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
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
First Submitted: December 9, 2005
First Posted: December 12, 2005
Results First Submitted: August 13, 2013
Results First Posted: November 8, 2013
Last Update Posted: December 3, 2013