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Trial record 17 of 103 for:    Valcyte

Valganciclovir to Reduce T Cell Activation in HIV Infection

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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

Tracking Information
First Submitted Date  ICMJE December 9, 2005
First Posted Date  ICMJE December 12, 2005
Results First Submitted Date  ICMJE August 13, 2013
Results First Posted Date  ICMJE November 8, 2013
Last Update Posted Date December 3, 2013
Study Start Date  ICMJE August 2006
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 9, 2005)
Change in T cell activation at week 8.
Change History Complete list of historical versions of study NCT00264290 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2013)
  • Change in CMV DNA Shedding From Baseline to Week 8. [ Time Frame: 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 and Plasma HIV RNA Levels at Week 8. [ Time Frame: week 8 ]
  • %CD38+HLA-DR+ CD8+ T Cells After a 4-week Washout Period [ Time Frame: Week 12 ]
  • Change in CMV DNA Shedding After a 4-week Washout Period [ Time Frame: Week 12 ]
  • Change in CD4 Counts and Plasma HIV RNA Levels After a 4-week Washout Period [ Time Frame: Week 12 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2005)
  • Change in CMV-specific T cell responses at week 8.
  • Change in CMV DNA shedding at week 8.
  • Change in CD4 Counts and Plasma HIV RNA Levels at Week 8.
  • Change in all of the above factors after a 4-week washout period.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Valganciclovir to Reduce T Cell Activation in HIV Infection
Official Title  ICMJE Valganciclovir to Reduce T Cell Activation in HIV Infection
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV Infections
  • Cytomegalovirus Infections
Intervention  ICMJE
  • 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
  • Drug: Placebo
    Placebo designed to resemble Valganciclovir
Study Arms  ICMJE
  • Experimental: Valganciclovir
    900mg PO qd
    Intervention: Drug: Valganciclovir
  • Placebo Comparator: Placebo
    900mg PO qd
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2005)
30
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00264290
Other Study ID Numbers  ICMJE H10775-26933-01
SFGH GCRC #976
5 P30 AI 27763 - Hunt
Roche VAL 104
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Roche Pharma AG
Investigators  ICMJE
Principal Investigator: Peter W. Hunt, M.D. University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP