Valganciclovir to Reduce T Cell Activation in HIV Infection

University of California San Francisco (UCSF)

Status and phase

Completed

Phase 4

Conditions

Cytomegalovirus Infections

HIV Infections

Treatments

Drug: Placebo

Drug: Valganciclovir

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00264290

5 P30 AI 27763 - Hunt

Roche VAL 104

SFGH GCRC #976

H10775-26933-01

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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