Valganciclovir to Reduce T Cell Activation in HIV Infection
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ClinicalTrials.gov Identifier: NCT00264290 |
Recruitment Status
:
Completed
First Posted
: December 12, 2005
Results First Posted
: November 8, 2013
Last Update Posted
: December 3, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Cytomegalovirus Infections | Drug: Valganciclovir Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Valganciclovir to Reduce T Cell Activation in HIV Infection |
Study Start Date : | August 2006 |
Actual Primary Completion Date : | October 2008 |
Actual Study Completion Date : | November 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: Valganciclovir
900mg PO qd
|
Drug: Valganciclovir
900mg PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone.
Other Names:
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Placebo Comparator: Placebo
900mg PO qd
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Drug: Placebo
Placebo designed to resemble Valganciclovir
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- Change in %CD38+ Human Leukocyte Antigen-D-related (HLA-DR)+ CD8+ T Cells From Baseline to Week 8. [ Time Frame: Baseline, 8 weeks ]The percentage of activated (CD38+ HLA-DR+) CD8+ T cells was measured on fresh whole blood at screening/baseline. T cell activation was measured on peripheral blood mononuclear cells (PBMCs)in batch at the end of the study.
- Change in CMV DNA Shedding From Baseline to Week 8. [ Time Frame: week 8 ]Change in percentage of participants with detectable CMV DNA. Herpesvirus DNA levels were assessed by polymerase chain reaction (lower limit of detection, 150 copies/mL) on saliva and seminal plasma.
- Change in Cluster of Differentiation 4 (CD4) Counts and Plasma HIV RNA Levels at Week 8. [ Time Frame: week 8 ]
- %CD38+HLA-DR+ CD8+ T Cells After a 4-week Washout Period [ Time Frame: Week 12 ]
- Change in CMV DNA Shedding After a 4-week Washout Period [ Time Frame: Week 12 ]
- Change in CD4 Counts and Plasma HIV RNA Levels After a 4-week Washout Period [ Time Frame: Week 12 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00264290
United States, California | |
San Francisco General Hospital - General Clinical Research Center | |
San Francisco, California, United States, 94110 |
Principal Investigator: | Peter W. Hunt, M.D. | University of California, San Francisco |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00264290 History of Changes |
Other Study ID Numbers: |
H10775-26933-01 SFGH GCRC #976 5 P30 AI 27763 - Hunt Roche VAL 104 |
First Posted: | December 12, 2005 Key Record Dates |
Results First Posted: | November 8, 2013 |
Last Update Posted: | December 3, 2013 |
Last Verified: | November 2013 |
Keywords provided by University of California, San Francisco:
HIV CMV T Cell activation Valganciclovir |
Additional relevant MeSH terms:
Infection Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome Cytomegalovirus Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Herpesviridae Infections DNA Virus Infections Valganciclovir Ganciclovir Antiviral Agents Anti-Infective Agents |