Trial Outcomes & Findings for Valganciclovir to Reduce T Cell Activation in HIV Infection (NCT NCT00264290)

NCT ID: NCT00264290

Last Updated: 2020-07-31

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 30 participants
• Primary outcome timeframe: Baseline, 8 weeks
• Results posted on: 2020-07-31

Participant Flow

Cytomegalovirus (CMV)-seropositive adults with chronic HIV infection were recruited at one US clinical site.

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.

Participant milestones

Measure	Placebo Placebo PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone.	Valganciclovir 900mg PO qd Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone.
Intervention (8 Weeks) STARTED	16	14
Intervention (8 Weeks) COMPLETED	15	14
Intervention (8 Weeks) NOT COMPLETED	1	0
Observation (4 Weeks) STARTED	15	14
Observation (4 Weeks) COMPLETED	15	14
Observation (4 Weeks) NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Placebo Placebo PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone.	Valganciclovir 900mg PO qd Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone.
Intervention (8 Weeks) Adverse Event	1	0

Baseline Characteristics

Valganciclovir to Reduce T Cell Activation in HIV Infection

Baseline characteristics by cohort

Measure	Placebo n=16 Participants Placebo PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.	Valganciclovir n=14 Participants 900mg PO qd Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	50 years n=5 Participants	48 years n=7 Participants	49 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	14 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Placebo n=15 Participants placebo PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.	Valganciclovir n=14 Participants 900mg PO qd Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.
Change in %CD38+ Human Leukocyte Antigen-D-related (HLA-DR)+ CD8+ T Cells From Baseline to Week 8.	1.3 percentage of activated T cells Interval -2.6 to 5.8	-4.0 percentage of activated T cells Interval -5.7 to -0.9

SECONDARY outcome

Timeframe: baseline and 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.

Outcome measures

Measure	Placebo n=14 Participants placebo PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.	Valganciclovir n=16 Participants 900mg PO qd Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.
Change in CMV DNA Shedding From Baseline to Week 8.	-36 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline and week 8

Outcome measures

Measure	Placebo n=16 Participants placebo PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.	Valganciclovir n=14 Participants 900mg PO qd Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.
Change in Cluster of Differentiation 4 (CD4) Counts at Week 8	-1 CD4 cells/mm3 Interval -19.0 to 16.0	-8 CD4 cells/mm3 Interval -38.0 to 22.0

SECONDARY outcome

Timeframe: Baseline and Week 12

Change from baseline at week 12

Outcome measures

Measure	Placebo n=16 Participants placebo PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.	Valganciclovir n=14 Participants 900mg PO qd Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.
Change in Percent of CD38+HLA-DR+ CD8+ T Cells After a 4-week Washout Period	1 %CD38+HLA-DR+ CD8+ T cells Interval -3.0 to 5.0	-4.1 %CD38+HLA-DR+ CD8+ T cells Interval -6.8 to -1.1

SECONDARY outcome

Timeframe: Week 12

Number of Participants with positive CMV DNA at any site at week 12

Outcome measures

Measure	Placebo n=16 Participants placebo PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.	Valganciclovir n=14 Participants 900mg PO qd Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.
Number of Participants With Positive CMV DNA After a 4-week Washout Period	0 Participants	3 Participants

SECONDARY outcome

Timeframe: Week 12

Change from baseline at week 12

Outcome measures

Measure	Placebo n=16 Participants placebo PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.	Valganciclovir n=14 Participants 900mg PO qd Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.
Change in CD4 Counts After a 4-week Washout Period	6 cells/mm3 Interval -11.0 to 23.0	-17 cells/mm3 Interval -47.0 to 12.0

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Valganciclovir

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=16 participants at risk Placebo PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.	Valganciclovir n=14 participants at risk 900mg PO qd Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.
Cardiac disorders congestive heart failure	6.2% 1/16 • Number of events 1 • 8 weeks of study treatment and a 4-week Observation Period	0.00% 0/14 • 8 weeks of study treatment and a 4-week Observation Period

Other adverse events

Adverse event data not reported

Additional Information

Peter W. Hunt, M.D.

University of California, San Francisco

Phone: 415-476-4082

Email: phunt@php.ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place