Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SFGH GCRC #976 | |||
| 5 P30 AI 27763 - Hunt | |||
| Roche VAL 104 | |||
| 5P30AI027763 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valganciclovir | Experimental | 900mg PO qd |
|
| Placebo | Placebo Comparator | 900mg PO qd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valganciclovir | Drug | 900mg PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in %CD38+ Human Leukocyte Antigen-D-related (HLA-DR)+ CD8+ T Cells From Baseline to Week 8. | 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. | Baseline, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CMV DNA Shedding From Baseline to 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. | baseline and week 8 |
| Change in Cluster of Differentiation 4 (CD4) Counts at Week 8 |
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter W. Hunt, M.D. | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco General Hospital - General Clinical Research Center | San Francisco | California | 94110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12721933 | Background | 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. | |
| 21502083 | Result | 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. |
Not provided
Not provided
Of 60 screened subjects, 3 refused participation and 27 did not meet eligibility criteria. The most common reason for exclusion was <10% activated Cluster of differentiation * (CD8)+ T cells.
Cytomegalovirus (CMV)-seropositive adults with chronic HIV infection were recruited at one US clinical site.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone. |
| FG001 | Valganciclovir | 900mg PO qd Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention (8 Weeks) |
|
| ||||||||||||||||||
| Observation (4 Weeks) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone. |
| BG001 | Valganciclovir | 900mg PO qd Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in %CD38+ Human Leukocyte Antigen-D-related (HLA-DR)+ CD8+ T Cells From Baseline to Week 8. | 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. | Posted | Mean | 95% Confidence Interval | percentage of activated T cells | Baseline, 8 weeks |
|
8 weeks of study treatment and a 4-week Observation Period
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| congestive heart failure | Cardiac disorders | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter W. Hunt, M.D. | University of California, San Francisco | 415-476-4082 | 345 | phunt@php.ucsf.edu |
Not provided
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077562 | Valganciclovir |
| ID | Term |
|---|---|
| D015774 | Ganciclovir |
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo designed to resemble Valganciclovir |
|
| Baseline and week 8 |
| Change in Percent of CD38+HLA-DR+ CD8+ T Cells After a 4-week Washout Period | Change from baseline at week 12 | Baseline and Week 12 |
| Number of Participants With Positive CMV DNA After a 4-week Washout Period | Number of Participants with positive CMV DNA at any site at week 12 | Week 12 |
| Change in CD4 Counts After a 4-week Washout Period | Change from baseline at week 12 | Week 12 |
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change in CMV DNA Shedding From Baseline to 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. | Posted | Number | percentage of participants | baseline and week 8 |
|
|
|
|
| Secondary | Change in Cluster of Differentiation 4 (CD4) Counts at Week 8 | Posted | Mean | 95% Confidence Interval | CD4 cells/mm3 | Baseline and week 8 |
|
|
|
| Secondary | Change in Percent of CD38+HLA-DR+ CD8+ T Cells After a 4-week Washout Period | Change from baseline at week 12 | Posted | Mean | 95% Confidence Interval | %CD38+HLA-DR+ CD8+ T cells | Baseline and Week 12 |
|
|
|
| Secondary | Number of Participants With Positive CMV DNA After a 4-week Washout Period | Number of Participants with positive CMV DNA at any site at week 12 | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| Secondary | Change in CD4 Counts After a 4-week Washout Period | Change from baseline at week 12 | Posted | Mean | 95% Confidence Interval | cells/mm3 | Week 12 |
|
|
|
| 1 |
| 16 |
| 0 |
| 16 |
| EG001 | Valganciclovir | 900mg PO qd Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone. | 0 | 14 | 0 | 14 |
Not provided
Not provided
Not provided
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |