Valganciclovir to Reduce T Cell Activation in HIV Infection

Completed · Phase 4 · Has a placebo group

Conditions studied: HIV Infections, Cytomegalovirus Infections

In brief

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.

Key facts

Study ID

NCT00264290

Run by

University of California, San Francisco

People needed

30

Starts

2006-08-01

Expected to finish

2008-11-01

Last updated by the study team

2020-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• San Francisco General Hospital - General Clinical Research Center — San Francisco, California, United States

Full record on ClinicalTrials.gov

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