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OpenTrials
Completed

NCT Number: NCT00264290

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Cytomegalovirus Infections DNA Virus Infections Genital Diseases Herpesviridae Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

San Francisco General Hospital - General Clinical Research Center

San Francisco, California, 94110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Valganciclovir

Drug

900mg PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone.

Other names: Valganciclovir (Valcyte), Placebo

Placebo

Drug

Placebo designed to resemble Valganciclovir

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Roche Pharma AG

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 12, 2005
Registry last updated
Jul 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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