Status:
COMPLETED
Valganciclovir to Reduce T Cell Activation in HIV Infection
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Roche Pharma AG
Conditions:
HIV Infections
Cytomegalovirus Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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, pot...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00264290
Start Date
August 1 2006
End Date
November 1 2008
Last Update
July 31 2020
Active Locations (1)
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1
San Francisco General Hospital - General Clinical Research Center
San Francisco, California, United States, 94110