Valganciclovir to Reduce T Cell Activation in HIV Infection

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: Roche Pharma AG
• Treatments: Ganciclovir; Valganciclovir

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