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Valganciclovir to Reduce T Cell Activation in HIV Infection

Primary Purpose

HIV Infections, Cytomegalovirus Infections

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Valganciclovir
Placebo
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV, CMV, T Cell activation, Valganciclovir

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Infection with HIV >1 year in duration. Age >18 Cytomegalovirus (CMV) antibody positive. All Cluster of Differentiation 4 (CD4)+ T cell counts in the last year and at screening <350 cells/mm3 On a stable highly addictive antiretroviral therapy (HAART) regimen (DHHS definition) for the preceding 6 months. 90% adherence to antiretroviral therapy within the preceding 30 days. Females of childbearing potential must have a negative serum pregnancy test at screening and all subjects must agree to use a double-barrier method of contraception throughout the study period. Screening %Cluster of differentiation 38 (CD38)+ Human leukocyte antigen-D-related (HLA-DR)+ Cluster of differentiation 8 (CD8)+ T cells >10% Exclusion Criteria: Patients intending to modify antiretroviral therapy in the next 16 weeks. Serious illness requiring hospitalization or parental antibiotics within preceding 3 months. Evidence of active symptomatic CMV end-organ disease. Treatment with valganciclovir or ganciclovir in the past 30 days. Concurrent treatment with immunomodulatory drugs. Concurrent treatment with nephrotoxic drugs Screening absolute neutrophil count <1,000 cells/mm3, platelet count <100,000 cells/mm3, hemoglobin < 8mg/dL, estimated creatinine clearance <50 mL/minute. Men who are considering having children will also be excluded given potential effects of valganciclovir on spermatogenesis. Pregnant or breastfeeding women

Sites / Locations

  • San Francisco General Hospital - General Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Valganciclovir

Placebo

Arm Description

900mg PO qd

900mg PO qd

Outcomes

Primary Outcome Measures

Change in %CD38+ Human Leukocyte Antigen-D-related (HLA-DR)+ CD8+ T Cells From Baseline to Week 8.
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.

Secondary Outcome Measures

Change in CMV DNA Shedding From Baseline to Week 8.
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.
Change in Cluster of Differentiation 4 (CD4) Counts at Week 8
Change in Percent of CD38+HLA-DR+ CD8+ T Cells After a 4-week Washout Period
Change from baseline at week 12
Number of Participants With Positive CMV DNA After a 4-week Washout Period
Number of Participants with positive CMV DNA at any site at week 12
Change in CD4 Counts After a 4-week Washout Period
Change from baseline at week 12

Full Information

First Posted
December 9, 2005
Last Updated
July 20, 2020
Sponsor
University of California, San Francisco
Collaborators
Roche Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT00264290
Brief Title
Valganciclovir to Reduce T Cell Activation in HIV Infection
Official Title
Valganciclovir to Reduce T Cell Activation in HIV Infection
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Roche Pharma AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether treatment with valganciclovir decreases T cell activation levels among HIV-infected patients with asymptomatic cytomegalovirus (CMV) co-infection, potentially improving immune responses to antiretroviral therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Cytomegalovirus Infections
Keywords
HIV, CMV, T Cell activation, Valganciclovir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Valganciclovir
Arm Type
Experimental
Arm Description
900mg PO qd
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
900mg PO qd
Intervention Type
Drug
Intervention Name(s)
Valganciclovir
Other Intervention Name(s)
Valganciclovir (Valcyte), Placebo
Intervention Description
900mg PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo designed to resemble Valganciclovir
Primary Outcome Measure Information:
Title
Change in %CD38+ Human Leukocyte Antigen-D-related (HLA-DR)+ CD8+ T Cells From Baseline to Week 8.
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
Secondary Outcome Measure Information:
Title
Change in CMV DNA Shedding From Baseline to Week 8.
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
baseline and week 8
Title
Change in Cluster of Differentiation 4 (CD4) Counts at Week 8
Time Frame
Baseline and week 8
Title
Change in Percent of CD38+HLA-DR+ CD8+ T Cells After a 4-week Washout Period
Description
Change from baseline at week 12
Time Frame
Baseline and Week 12
Title
Number of Participants With Positive CMV DNA After a 4-week Washout Period
Description
Number of Participants with positive CMV DNA at any site at week 12
Time Frame
Week 12
Title
Change in CD4 Counts After a 4-week Washout Period
Description
Change from baseline at week 12
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Infection with HIV >1 year in duration. Age >18 Cytomegalovirus (CMV) antibody positive. All Cluster of Differentiation 4 (CD4)+ T cell counts in the last year and at screening <350 cells/mm3 On a stable highly addictive antiretroviral therapy (HAART) regimen (DHHS definition) for the preceding 6 months. 90% adherence to antiretroviral therapy within the preceding 30 days. Females of childbearing potential must have a negative serum pregnancy test at screening and all subjects must agree to use a double-barrier method of contraception throughout the study period. Screening %Cluster of differentiation 38 (CD38)+ Human leukocyte antigen-D-related (HLA-DR)+ Cluster of differentiation 8 (CD8)+ T cells >10% Exclusion Criteria: Patients intending to modify antiretroviral therapy in the next 16 weeks. Serious illness requiring hospitalization or parental antibiotics within preceding 3 months. Evidence of active symptomatic CMV end-organ disease. Treatment with valganciclovir or ganciclovir in the past 30 days. Concurrent treatment with immunomodulatory drugs. Concurrent treatment with nephrotoxic drugs Screening absolute neutrophil count <1,000 cells/mm3, platelet count <100,000 cells/mm3, hemoglobin < 8mg/dL, estimated creatinine clearance <50 mL/minute. Men who are considering having children will also be excluded given potential effects of valganciclovir on spermatogenesis. Pregnant or breastfeeding women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter W. Hunt, M.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco General Hospital - General Clinical Research Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12721933
Citation
Hunt PW, Martin JN, Sinclair E, Bredt B, Hagos E, Lampiris H, Deeks SG. T cell activation is associated with lower CD4+ T cell gains in human immunodeficiency virus-infected patients with sustained viral suppression during antiretroviral therapy. J Infect Dis. 2003 May 15;187(10):1534-43. doi: 10.1086/374786. Epub 2003 Apr 23.
Results Reference
background
PubMed Identifier
21502083
Citation
Hunt PW, Martin JN, Sinclair E, Epling L, Teague J, Jacobson MA, Tracy RP, Corey L, Deeks SG. Valganciclovir reduces T cell activation in HIV-infected individuals with incomplete CD4+ T cell recovery on antiretroviral therapy. J Infect Dis. 2011 May 15;203(10):1474-83. doi: 10.1093/infdis/jir060.
Results Reference
result

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Valganciclovir to Reduce T Cell Activation in HIV Infection

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