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Valganciclovir to Reduce T Cell Activation in HIV Infection

CompletedPhase 4

Sponsor: University of California, San Francisco

Conditions: HIV Infections, Cytomegalovirus Infections

Interventions: Valganciclovir, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

San Francisco, California, United States