Phase 4
N=30
Valganciclovir to Reduce T Cell Activation in HIV Infection
HIV Infections · Cytomegalovirus Infections
Bottom Line
View on ClinicalTrials.gov: NCT00264290 ↗Enrolled (actual)
30
Serious AEs
3.3%
Results posted
Nov 2013
Primary outcome: Primary: Change in %CD38+ Human Leukocyte Antigen-D-related (HLA-DR)+ CD8+ T Cells From Baseline to Week 8. — 1.3; -4.0 percentage of activated T cells
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Valganciclovir (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in %CD38+ Human Leukocyte Antigen-D-related (HLA-DR)+ CD8+ T Cells From Baseline to Week 8. |
1.3; -4.0 | — |
| SECONDARY Change in CMV DNA Shedding From Baseline to Week 8. |
-36; 0 | 0.007 sig |
| SECONDARY Change in Cluster of Differentiation 4 (CD4) Counts at Week 8 |
-1; -8 | — |
| SECONDARY Change in Percent of CD38+HLA-DR+ CD8+ T Cells After a 4-week Washout Period |
1; -4.1 | — |
| SECONDARY Number of Participants With Positive CMV DNA After a 4-week Washout Period |
0; 3 | — |
| SECONDARY Change in CD4 Counts After a 4-week Washout Period |
6; -17 | — |
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, potentially improving immune responses to antiretroviral therapy.
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 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
Data sourced from ClinicalTrials.gov (NCT00264290). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.