Working… Menu

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. Identifier: NCT00264290
Recruitment Status : Completed
First Posted : December 12, 2005
Results First Posted : November 8, 2013
Last Update Posted : July 31, 2020
Roche Pharma AG
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
HIV Infections Cytomegalovirus Infections Drug: Valganciclovir Drug: Placebo Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Valganciclovir to Reduce T Cell Activation in HIV Infection
Study Start Date : August 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : November 2008

Arm Intervention/treatment
Experimental: Valganciclovir
900mg PO qd
Drug: Valganciclovir
900mg PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone.
Other Names:
  • Valganciclovir (Valcyte)
  • Placebo

Placebo Comparator: Placebo
900mg PO qd
Drug: Placebo
Placebo designed to resemble Valganciclovir

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

  2. Change in Cluster of Differentiation 4 (CD4) Counts at Week 8 [ Time Frame: Baseline and week 8 ]
  3. Change in Percent of CD38+HLA-DR+ CD8+ T Cells After a 4-week Washout Period [ Time Frame: Baseline and Week 12 ]
    Change from baseline at week 12

  4. Number of Participants With Positive CMV DNA After a 4-week Washout Period [ Time Frame: Week 12 ]
    Number of Participants with positive CMV DNA at any site at week 12

  5. Change in CD4 Counts After a 4-week Washout Period [ Time Frame: Week 12 ]
    Change from baseline at week 12

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00264290

Layout table for location information
United States, California
San Francisco General Hospital - General Clinical Research Center
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Roche Pharma AG
Layout table for investigator information
Principal Investigator: Peter W. Hunt, M.D. University of California, San Francisco
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: University of California, San Francisco Identifier: NCT00264290    
Other Study ID Numbers: H10775-26933-01
5 P30 AI 27763 - Hunt
Roche VAL 104
First Posted: December 12, 2005    Key Record Dates
Results First Posted: November 8, 2013
Last Update Posted: July 31, 2020
Last Verified: July 2020
Keywords provided by University of California, San Francisco:
T Cell activation
Additional relevant MeSH terms:
Layout table for MeSH terms
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Cytomegalovirus Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Antiviral Agents
Anti-Infective Agents