Valganciclovir to Reduce T Cell Activation in HIV Infection
NCT ID: NCT00264290
Last Updated: 2020-07-31
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2006-08-31
2008-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Preventing Cytomegalovirus (CMV) Organ Damage With Valganciclovir in People With HIV
NCT00006145
A Study of Valganciclovir in the Treatment of Cytomegalovirus (CMV) Retinitis in Patients With AIDS
NCT00002222
A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Large Intestine in Patients With AIDS
NCT00002273
Valganciclovir in Patients With CMV Retinitis and AIDS Who Cannot Take Drugs by Injection
NCT00017784
IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients
NCT00294515
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Valganciclovir
900mg PO qd
Valganciclovir
900mg PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone.
Placebo
900mg PO qd
Placebo
Placebo designed to resemble Valganciclovir
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Valganciclovir
900mg PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone.
Placebo
Placebo designed to resemble Valganciclovir
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Roche Pharma AG
INDUSTRY
University of California, San Francisco
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Peter W. Hunt, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
San Francisco General Hospital - General Clinical Research Center
San Francisco, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Hunt PW, Martin JN, Sinclair E, Bredt B, Hagos E, Lampiris H, Deeks SG. T cell activation is associated with lower CD4+ T cell gains in human immunodeficiency virus-infected patients with sustained viral suppression during antiretroviral therapy. J Infect Dis. 2003 May 15;187(10):1534-43. doi: 10.1086/374786. Epub 2003 Apr 23.
Hunt PW, Martin JN, Sinclair E, Epling L, Teague J, Jacobson MA, Tracy RP, Corey L, Deeks SG. Valganciclovir reduces T cell activation in HIV-infected individuals with incomplete CD4+ T cell recovery on antiretroviral therapy. J Infect Dis. 2011 May 15;203(10):1474-83. doi: 10.1093/infdis/jir060.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SFGH GCRC #976
Identifier Type: -
Identifier Source: secondary_id
5 P30 AI 27763 - Hunt
Identifier Type: -
Identifier Source: secondary_id
Roche VAL 104
Identifier Type: -
Identifier Source: secondary_id
H10775-26933-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.