A Phase 2 interventional study of Valganciclovir and Ganciclovir (GCV) in Cytomegalovirus (CMV), Anterior Uveitis and Infectious Uveitis, sponsored by University of California, San Francisco. Not yet recruiting at 6 sites in 3 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by University of California, San Francisco · Phase 2, Interventional, and Treatment
The goal of this clinical trial is to compare antiviral treatment strategies for cytomegalovirus (CMV) anterior uveitis - a viral infection causing inflammation inside the front of the eye - in immunocompetent adults aged 18 years and older. The main questions it aims to answer are:
Does oral valganciclovir reduce aqueous humor CMV viral load more effectively than topical ganciclovir 2% eye drops or placebo after 7 days of treatment (Trial I)? Does long-term suppressive antiviral therapy (oral valganciclovir or topical ganciclovir 2% eye drops) reduce the rate of CMV anterior uveitis recurrence over 12 months compared to placebo (Trial II)?
Researchers will compare oral valganciclovir, topical ganciclovir 2% eye drops, and placebo to see if either antiviral treatment reduces viral load and controls eye inflammation more effectively in the short term, and whether long-term antiviral suppression can prevent the disease from coming back after the inflammation has been controlled.
Participants will:
Cytomegalovirus (CMV) anterior uveitis is an increasingly recognized cause of recurrent and chronic ocular inflammation in immunocompetent individuals, accounting for up to 25% of anterior uveitis cases at specialized centers. The condition typically presents with unilateral hypertensive uveitis, coin-shaped or stellate keratic precipitates, and variable anterior chamber inflammation. Without adequate treatment, CMV anterior uveitis can lead to secondary glaucoma from trabecular meshwork damage and corneal endothelial decompensation, both of which may result in permanent vision loss. Diagnosis requires PCR detection of CMV DNA in aqueous humor via anterior chamber paracentesis.
Despite growing recognition, particularly in Asian and Asian-American populations, no randomized controlled trial has previously established an evidence-based treatment protocol. Observational data and small case series suggest that both oral valganciclovir and topical ganciclovir 2% ophthalmic solution can suppress CMV replication and control inflammation, and that some cases improve without antiviral therapy. However, the relative efficacy of these approaches has not been formally compared, and whether long-term antiviral suppression prevents disease recurrence remains undefined. Prior observational work has demonstrated a correlation between higher aqueous CMV DNA viral load and worse anterior segment outcomes, including greater corneal endothelial cell loss, providing biological rationale for targeting viral load as a primary endpoint in a treatment trial.
Study Design: STACCATO is a sequential, double-masked, placebo-controlled randomized clinical trial consisting of two linked sub-studies (Trial I and Trial II) conducted at six international sites: the Francis I. Proctor Foundation at UCSF (clinical and data coordinating center), UCLA, Chulalongkorn University (Bangkok, Thailand), Khon Kaen University (Khon Kaen, Thailand), Chiang Mai University (Chiang Mai, Thailand), and Chang Gung Memorial Hospital (Taoyuan, Taiwan). Both trials employ a three-arm parallel-group design with 1:1:1 allocation. Randomization uses site-stratified permuted blocks (block sizes 3 and 6) to ensure balance across sites. Allocation concealment is maintained through a centralized electronic randomization system. Both participants and treating ophthalmologists are masked to treatment assignment throughout each trial period. Active and matching placebo tablets and eye drops are identical in appearance, packaging, and administration schedule.
Trial I: Acute Treatment (7-Day Intervention) Trial I evaluates the short-term virologic and clinical effects of antiviral therapy in participants with PCR-confirmed active CMV anterior uveitis. Participants are randomized to one of three treatment arms: Arm 1: oral valganciclovir 900 mg (two 450 mg tablets) twice daily for 7 days, plus matching placebo eye drops six times daily; Arm 2: topical ganciclovir 2% ophthalmic solution six times daily for 7 days, plus matching placebo tablets twice daily; Arm 3: matching placebo tablets twice daily plus matching placebo eye drops six times daily. All participants receive topical prednisolone acetate 1% as standard of care for inflammation control; ocular hypotensive medications are added as clinically indicated for intraocular pressure management.
The primary endpoint of Trial I is log10-transformed aqueous humor CMV viral load at Day 7, measured by quantitative PCR (qPCR) at the central laboratory (Stanford University). Aqueous humor samples are obtained at baseline (Exam 0, pre-enrollment paracentesis) and at Day 7 (Exam 2) via anterior chamber paracentesis; approximately 100 µL are collected at each visit, of which approximately 50 µL is used for local directed qualitative PCR testing for eligibility determination (CMV, HSV, and VZV), and the remaining sample is stored at -80°C and shipped to the central laboratory for quantitative CMV PCR analysis. The pre-specified aqueous lower limit of quantitation (LLOQ) is 2,700 IU/mL (3.43 log10 IU/mL), based on the assay's plasma-validated linear range of 135-6,750,000 IU/mL (2.13-6.83 log10 IU/mL) with 50 µL samples diluted to 1 mL. Viral load values reported as not detected are imputed using maximum likelihood estimation (MLE) in the primary analysis, with sensitivity analyses employing alternative imputation strategies.
Secondary endpoints in Trial I include: (1) proportion of participants achieving clinical inactivity (≤0.5+ anterior chamber cell per SUN criteria) at Days 7 and 21; (2) intraocular pressure (IOP) in mmHg at Days 7 and 21; and (3) visual acuity (logMAR) at Days 7 and 21. A nested observational analysis evaluates the effect of pre-enrollment topical corticosteroid use on baseline aqueous CMV viral load.
Trial II: Long-Term Suppressive Therapy (12-Month Follow-up) Trial II evaluates whether long-term antiviral suppression reduces the rate of inflammatory recurrence in participants who have achieved clinical quiescence following PCR-confirmed CMV anterior uveitis. Participants may enter Trial II via two pathways: (1) participants who complete Trial I and subsequently achieve clinical inactivity, defined as ≤0.5+ anterior chamber cell sustained for at least 2 weeks with a minimum 2-week washout from antiviral therapy; or (2) patients with previously PCR-confirmed CMV anterior uveitis who are already clinically inactive and have not participated in Trial I.
Upon enrollment, participants are re-randomized (independently of their Trial I assignment) to one of three long-term suppressive regimens: Arm 1: oral valganciclovir at suppressive dosing for 12 months, plus matching placebo eye drops; Arm 2: topical ganciclovir 2% ophthalmic solution at maintenance dosing for 12 months, plus matching placebo tablets; Arm 3: matching placebo tablets plus matching placebo eye drops for 12 months.
The primary endpoint of Trial II is recurrence of anterior uveitis inflammation, defined as ≥1+ anterior chamber cell, over 12 months of follow-up. Participants are assessed for recurrence at scheduled visits (approximately months 1, 3, 5, 7, 9, 11, and 12 after randomization) and at unscheduled visits prompted by participant-reported symptoms. If recurrent inflammation is detected at any visit, an anterior chamber paracentesis is performed to assess for the presence of detectable CMV viral load in aqueous humor, and the participant exits the study. A secondary endpoint of Trial II is the prevalence of CMV mutations conferring antiviral resistance in aqueous humor at recurrence, assessed by viral genomic sequencing.
Genomic and Translational Aims: Aqueous humor samples from baseline (Trial I, Exam 0) and recurrence visits (Trial II) are subjected to RNA sequencing to characterize host transcriptional signatures and viral genomic features associated with CMV anterior uveitis. Specific hypotheses include: (a) participants who experience recurrent inflammation after antiviral suppression will have a higher prevalence of CMV resistance mutations compared to baseline samples from Trial I; (b) host transcriptional profiles will distinguish CMV-positive from CMV-negative anterior uveitis; and (c) unique transcriptional signatures will be associated with recurrent inflammation in Trial II participants. This aim is designed to identify biomarkers of treatment response and recurrence risk, and to elucidate mechanisms of viral persistence and resistance informing future therapeutic development.
Statistical Analysis Plan Sample Size: Trial I is powered to detect a 0.8 log10 IU/mL difference in post-treatment CMV viral load between oral valganciclovir and each comparator arm. With baseline viral load as a covariate (ANCOVA), 39 participants per arm (117 total) provides 80% power at a two-sided alpha of 0.05, accounting for approximately 10% loss to follow-up. For Trial II, assuming a 25% recurrence rate in the placebo group, 33 participants per arm (99 total) provides 80% power to detect a 36 percentage-point reduction in recurrence risk at a two-sided alpha of 0.05.
Primary Analyses: The primary efficacy analysis for Trial I compares log10-transformed post-treatment viral loads using ANCOVA, adjusting for baseline viral load, treatment arm, and research site. Multiple comparison adjustment uses the max-T method for the two primary comparisons (oral valganciclovir vs. topical ganciclovir 2%, and oral valganciclovir vs. placebo); topical ganciclovir 2% vs. placebo is a pre-specified secondary comparison. The primary analysis for Trial II uses log-binomial regression to evaluate the risk of inflammatory recurrence over 12 months, adjusted for baseline viral load, treatment arm, and research site.
Secondary and Sensitivity Analyses: Secondary clinical endpoints in both trials are analyzed using linear regression (continuous outcomes) or log-binomial regression (binary outcomes) with analogous covariate adjustment. Pre-specified sensitivity analyses for Trial I evaluate robustness to alternative approaches for undetectable viral load values, including substitution with 1 IU/mL, MLE imputation below the LLOQ, exclusion of participants with undetectable pre-treatment viral loads, and binarization by LLOQ or detectability thresholds. Subgroup analyses include stratification by sex and adjustment for glaucoma medication use as a proxy for baseline disease severity.
Interim Analyses and Stopping Rules: An independent Data Safety Monitoring Board (DSMB) will review accumulating safety and efficacy data at scheduled intervals throughout both trials. Formal interim efficacy analyses employ the O'Brien-Fleming alpha spending approach to preserve overall Type I error. The DSMB has authority to recommend early study modification or termination for safety or overwhelming efficacy.
Prior Work: Pilot STACCATO Trial The current study builds on the completed pilot STACCATO trial (NCT03586284), which enrolled 51 participants across three sites (UCSF, Chulalongkorn University, and Khon Kaen University) between January 2020 and March 2024. The pilot demonstrated feasibility of double-masked RCTs with repeated anterior chamber paracentesis in CMV anterior uveitis. Oral valganciclovir produced the largest absolute reduction in aqueous CMV viral load at Day 7 (0.44 log10 IU/mL), though between-arm differences did not reach statistical significance in this underpowered cohort (early termination due to COVID-19). Baseline and Day 7 viral loads were strongly correlated (Pearson's r=0.774). No serious procedural complications (endophthalmitis, traumatic cataract) were observed. The current study is powered to detect the virologic and clinical differences suggested by these pilot data.
Study Oversight and Data Management The study is overseen by an independent DSMB comprising a uveitis/ocular infectious disease specialist, a biostatistician with clinical trial expertise, and an infectious disease/antiviral pharmacology specialist, none affiliated with the participating institutions. Study data are captured in a validated electronic data capture system with built-in range checks and logic validation; source data verification is conducted at each site. Quantitative PCR analyses of all aqueous humor samples are performed at the central laboratory (Stanford University) to ensure assay comparability across sites and throughout the study period. The study is funded by the National Eye Institute-National Institutes of Health.
56 studies on the registry are indexed under Uveitis, Anterior; 9 are open to participants now.
This study's planned enrollment of 117 is above the median of 50 across 45 interventional studies indexed under Uveitis, Anterior.
Browse Uveitis, Anterior studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Trial I - Inclusion Criteria
Trial II - Inclusion Criteria
Participants may enter Trial II via one of two pathways. All participants must meet the following general inclusion criteria:
Exclusion Criteria:
Trial I - Exclusion Criteria
Trial II - Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral valganciclovir 900 mg twice daily.
Drug: Valganciclovir
Topical ganciclovir instilled into affected eye 6 times daily.
Drug: Ganciclovir (GCV)
This arm does not receive antiviral therapy, but this arm will receive topical corticosteroid eye drop like the other two active arms for inflammation management.
Drug: Placebo
Trial I will use oral valganciclovir 450 mg tablet (2 tablets twice daily). Trial II will use oral valganciclovir 450 mg tablet (1 tablet twice daily).
Also known as: Oral valganciclovir
Ganciclovir 2% eye drop (compounded).
Also known as: Topical ganciclovir eye drops
Placebo tablets and placebo drops.
Primary Outcome Measure - Trial I
Trial I Aqueous Humor CMV Viral Load at Day 7
Time frame: 7 days
Primary Outcome Measure - Trial II
Trial II Recurrence of Anterior Uveitis Inflammation Over 12 Months
Time frame: 12 months
Secondary Outcome Measure - Trial I
Trial I proportion of patients achieving clinical inactivity of anterior chamber inflammation at Day 7
Time frame: 7 days
Secondary Outcome Measure Trial I at 21 days
Trial I Clinical proportion of patients achieving clinical inactivity of anterior chamber Inflammation at Day 21
Time frame: 21 days
Trial I intraocular pressure at 7 days
Trial I Intraocular Pressure at Day 7
Time frame: 7 days
Intraocular pressure at 21 days
Trial I Intraocular Pressure at Day 21
Time frame: 21 days
Visual acuity at 7 days
Trial I Visual Acuity at Day 7
Time frame: 7 days
Visual acuity at 21 days
Trial I Visual Acuity at Day 21
Time frame: 21 days
Topical corticosteroid effect on baseline CMV viral load
Change in aqueous humor CMV viral load (IU/mL) per additional topical corticosteroid drop used daily at the time of first anterior chamber paracentesis
Time frame: 7 days
Presence of detectable CMV viral load during recurrence in Trial II
Trial II Presence of Detectable Aqueous CMV Viral Load at Time of Recurrence
Time frame: 12 months
Trial topical ganciclovir 2% vs placebo
Trial I Topical Ganciclovir 2% Versus Placebo: Post-Treatment CMV Viral Load at Day 7 (Subsidiary Analysis)
Time frame: 7 days
Prevalence of CMV antiviral resistance mutations in Trial II recurences
Trial II Prevalence of CMV Mutations Conferring Antiviral Resistance at Time of Recurrence
Time frame: 12 months
Host transcriptional profiles
Specific Aim 3 Host Transcriptional Signatures in CMV Anterior Uveitis (Translational)
Time frame: 12 months
Time to first recurrence during Trial II
Trial II Time to First Recurrence of Inflammation
Time frame: 12 months
Plan to share: No — Individual participant data (IPD) will not be shared beyond the study team and authorized oversight bodies. The study involves sensitive personal health information from participants across international sites in the United States, Thailand, and Taiwan. Sharing IPD raises privacy and confidentiality concerns given variability in data protection regulations across jurisdictions. De-identified aggregate data and results will be made available through peer-reviewed publication and ClinicalTrials.gov results reporting. Requests for de-identified data for secondary research may be considered following primary results publication, subject to IRB approval and a data sharing agreement with the principal investigator.
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Studies of the drugs tested here: Valganciclovir · Ganciclovir
University of California, San Francisco →