skip to content

Clinical Trials

MainTitle

Valganciclovir to Reduce T Cell Activation in HIV Infection

This study has been completed
Sponsor
University of California, San Francisco

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
History of Changes
Purpose

Purpose

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 Intervention Phase
HIV Infections
Cytomegalovirus Infections

Drug : Valganciclovir
Drug : Placebo
Phase 4

Study Type: Interventional
Study Design: 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

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures

  • 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:
  • 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 ]

Enrollment: 30
Study Start Date: August 2006
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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 Name:
  • Valganciclovir (Valcyte)
  • Placebo

Placebo Comparator: Placebo
900mg PO qd
Drug: Placebo

Placebo designed to resemble Valganciclovir

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264290

Locations

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

Investigators

Principal Investigator: Peter W. Hunt, M.D. University of California, San Francisco
More Information

More Information


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  
Study First Received: December 9, 2005  
Last Updated: November 7, 2013  

Keywords provided by University of California, San Francisco:

HIV
CMV
T Cell activation
Valganciclovir

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Cytomegalovirus Infections
Valganciclovir
Ganciclovir

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.