Valganciclovir to Reduce T Cell Activation in HIV Infection
This study has been completed.
Sponsor:
University of California, San Francisco
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Peter Hunt, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00264290
First received: December 9, 2005
Last updated: September 13, 2011
Last verified: September 2011
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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 |
Phase 4 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Official Title: | Valganciclovir to Reduce T Cell Activation in HIV Infection |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Valganciclovir hydrochloride
U.S. FDA Resources
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- Change in %CD38+HLA-DR+ CD8+ T cells at week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in CMV DNA shedding at week 8. [ Time Frame: week 8 ] [ Designated as safety issue: No ]
- Change in CD4 counts and plasma HIV RNA levels at week 8. [ Time Frame: week 8 ] [ Designated as safety issue: No ]
- Change in all of the above factors after a 4-week washout period. [ Time Frame: weeks 8-12 ] [ Designated as safety issue: No ]
Enrollment: | 30 |
Study Start Date: | August 2006 |
Study Completion Date: | November 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Valganciclovir
900mg PO qd
|
Drug: Valganciclovir
900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.
Other Names:
|
Placebo Comparator: Placebo
900mg PO qd
|
Drug: Valganciclovir
900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.
Other Names:
|
![](https://webarchive.library.unt.edu/web/20130312224733im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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 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
![](https://webarchive.library.unt.edu/web/20130312224733im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00264290
Locations
United States, California | |
San Francisco General Hospital - General Clinical Research Center | |
San Francisco, California, United States, 94110 |
Sponsors and Collaborators
University of California, San Francisco
Roche Pharma AG
Investigators
Principal Investigator: | Peter W. Hunt, M.D. | University of California, San Francisco |
![](https://webarchive.library.unt.edu/web/20130312224733im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Peter Hunt, Assistant Professor of Medicine, 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 |
Study First Received: | December 9, 2005 |
Last Updated: | September 13, 2011 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
HIV CMV T Cell activation Valganciclovir |
Additional relevant MeSH terms:
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 Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 10, 2013