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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Valganciclovir to Reduce T Cell Activation in HIV Infection

Resource links provided by NLM:


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 ] [ 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.


Secondary Outcome Measures:
  • 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 ]

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 Names:
  • Valganciclovir (Valcyte)
  • Placebo
Placebo Comparator: Placebo
900mg PO qd
Drug: Placebo
Placebo designed to resemble Valganciclovir

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Results First Received: August 13, 2013
Last Updated: November 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
HIV
CMV
T Cell activation
Valganciclovir

Additional relevant MeSH terms:
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
Valganciclovir
Ganciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014