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

December 9, 2005
November 7, 2013
August 2006
October 2008   (final data collection date for primary outcome measure)
Change in %CD38+ Human Leukocyte Antigen-D-related (HLA-DR)+ CD8+ T Cells From Baseline to Week 8. [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
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.
Change in T cell activation at week 8.
Complete list of historical versions of study NCT00264290 on ClinicalTrials.gov Archive Site
  • Change in CMV DNA Shedding From Baseline to Week 8. [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • %CD38+HLA-DR+ CD8+ T Cells After a 4-week Washout Period [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change in CMV DNA Shedding After a 4-week Washout Period [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change in CD4 Counts and Plasma HIV RNA Levels After a 4-week Washout Period [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • 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.
Not Provided
Not Provided
 
Valganciclovir to Reduce T Cell Activation in HIV Infection
Valganciclovir to Reduce T Cell Activation in HIV Infection

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • HIV Infections
  • Cytomegalovirus Infections
  • 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
  • Experimental: Valganciclovir
    900mg PO qd
    Intervention: Drug: Valganciclovir
  • Placebo Comparator: Placebo
    900mg PO qd
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
November 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00264290
H10775-26933-01, SFGH GCRC #976, 5 P30 AI 27763 - Hunt, Roche VAL 104
No
University of California, San Francisco
University of California, San Francisco
Roche Pharma AG
Principal Investigator: Peter W. Hunt, M.D. University of California, San Francisco
University of California, San Francisco
November 2013

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