HIV InfectionsPhase 4NCT00264290
Valganciclovir to Reduce T Cell Activation in HIV Infection
A Phase 4 study testing Valganciclovir in people with HIV Infections and Cytomegalovirus Infections, run by University of California, San Francisco at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Cytomegalovirus Infections
- What is being tested?
- Valganciclovir
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Nov 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco General Hospital - General Clinical Research Center
San Francisco, California, 94110
About this study
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.
- Conditions
- HIV Infections, Cytomegalovirus Infections
- Being tested
- Valganciclovir, Placebo
- Keywords
- HIV, CMV, T Cell activation, Valganciclovir
- Medical subject headings
- HIV Infections, Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValganciclovirDrug
Also called Valganciclovir (Valcyte), Placebo
900mg PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone.
PlaceboDrug
Placebo designed to resemble Valganciclovir
| Study group | Role | What they receive |
|---|---|---|
| Valganciclovir | Experimental | 900mg PO qd Receives: Drug: Valganciclovir |
| Placebo | Placebo comparator | 900mg PO qd Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 8 weeks
Secondary outcomes (5)
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.
Measured: baseline and week 8
Change in Cluster of Differentiation 4 (CD4) Counts at Week 8
Measured: 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
Measured: 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
Measured: Week 12
Change in CD4 Counts After a 4-week Washout Period
Change from baseline at week 12
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2005 (estimated)
- Study startAug 2006
- Primary completionOct 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Peter W. Hunt, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264290
- Sponsor's protocol ID
- H10775-26933-01
- Other IDs
- SFGH GCRC #976, 5 P30 AI 27763 - Hunt, Roche VAL 104, 5P30AI027763
- Status last verified
- Jul 2020
- First submitted
- 9 Dec 2005
- Last updated
- 31 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 12721933Hunt 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.
PubMed 21502083
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valganciclovir to Reduce T Cell Activation in HIV Infection
- ClinicalTrials.gov ID
- NCT00264290
- Acronym / sponsor ID
- H10775-26933-01
- Conditions
- HIV Infections, Cytomegalovirus Infections
- Keywords
- HIV, CMV, T Cell activation, Valganciclovir
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Aug 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 12 Dec 2005 (estimated)
- Results
- Posted 8 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valganciclovir | Experimental | Drug: Valganciclovir900mg PO qd |
| Placebo | Placebo comparator | Drug: Placebo900mg PO qd |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ValganciclovirAlso: Valganciclovir (Valcyte), Placebo900mg PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone. | Drug | Valganciclovir |
| PlaceboPlacebo designed to resemble Valganciclovir | Drug | Placebo |
Primary outcome
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.
5 secondary outcomes
Change in CMV DNA Shedding From Baseline to Week 8.
Time frame: baseline and week 8
Change in Cluster of Differentiation 4 (CD4) Counts at Week 8
Time frame: Baseline and week 8
Change in Percent of CD38+HLA-DR+ CD8+ T Cells After a 4-week Washout Period
Time frame: Baseline and Week 12
Number of Participants With Positive CMV DNA After a 4-week Washout Period
Time frame: Week 12
Change in CD4 Counts After a 4-week Washout Period
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12721933Hunt 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.
- Results publication: PubMed 21502083Hunt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter W. Hunt, M.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Valganciclovir in people with HIV Infections and Cytomegalovirus Infections, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in %CD38+ Human Leukocyte Antigen-D-related (HLA-DR)+ CD8+ T Cells From Baseline to Week 8. (time frame: Baseline, 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00264290, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020.