Valganciclovir to Reduce T Cell Activation in HIV Infection

University of California, San Francisco30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

HIV Infections Cytomegalovirus Infections

Interventions

ValganciclovirDRUG

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

PlaceboDRUG

Placebo designed to resemble Valganciclovir

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

San Francisco General Hospital - General Clinical Research Center

San Francisco, California, United States

Outcomes

Primary Outcomes

Change in %CD38+ Human Leukocyte Antigen-D-related (HLA-DR)+ CD8+ T Cells From Baseline to Week 8.

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.

Time frame: Baseline, 8 weeks

Secondary Outcomes

Change in CMV DNA Shedding From Baseline to 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.

Time frame: baseline and week 8

Change in Cluster of Differentiation 4 (CD4) Counts at Week 8

Time frame: Baseline and week 8

Change in Percent of CD38+HLA-DR+ CD8+ T Cells After a 4-week Washout Period

Change from baseline at week 12

Time frame: Baseline and Week 12

Number of Participants With Positive CMV DNA After a 4-week Washout Period

Number of Participants with positive CMV DNA at any site at week 12

Time frame: Week 12

Change in CD4 Counts After a 4-week Washout Period

Change from baseline at week 12

Time frame: Week 12

Data from ClinicalTrials.gov

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