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.

Condition	Intervention	Phase
HIV Infections Cytomegalovirus Infections	Drug: valganciclovir 900mg daily vs. placebo x 8 weeks	Phase IV

Further study details as provided by University of California, San Francisco:

Primary Outcomes: Change in T cell activation at week 8.
Secondary Outcomes: Change in CMV-specific T cell responses at week 8.; Change in CMV DNA shedding at week 8.; Change in CD4 counts and plasma HIV RNA levels at week 8.; Change in all of the above factors after a 4-week washout period.
Expected Total Enrollment:  30

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Infection with HIV >1 year in duration.
• Age >18
• CMV antibody positive.
• All CD4+ T cell counts in the last year and at screening <350 cells/mm3

• On a stable 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 %CD38+HLA-DR+ 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, ganciclovir, acyclovir, or valacyclovir 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00264290

Peter W. Hunt, M.D.      (415) 476-4082  Ext. 345    phunt@php.ucsf.edu
Steven G. Deeks, M.D.      (415) 476-4082  Ext. 404    sdeeks@php.ucsf.edu

California
      San Francisco General Hospital - General Clinical Research Center, San Francisco,  California,  94110,  United States

Study chairs or principal investigators

Peter W. Hunt, M.D.,  Principal Investigator,  University of California, San Francisco   

Study ID Numbers:  H10775-26933-01; SFGH GCRC #976; 5 P30 AI 27763 - Hunt
Last Updated:  December 9, 2005
Record first received:  December 9, 2005
ClinicalTrials.gov Identifier:  NCT00264290
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-01-10