Clinical trial · Interventional
Suppression of Oral HHV8 Shedding With Valganciclovir
Suppression of Oral Shedding of Human Herpesvirus 8 (HHV-8) With Valganciclovir
NCT00194467CI-TRIAL-00001092completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to use valganciclovir to define the role of antiviral therapy in suppression of HHV-8 shedding in HHV-8 seropositive men. Our hypothesis is that valganciclovir will substantially reduce the frequency of detection and amount of HHV-8 in the mouth.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Herpesvirus 8 | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Drug | — | UNRESOLVED |
| valganciclovir | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: valganciclovir
- type
- PLACEBO_COMPARATOR
- label
- 2
- interventionNames
- Drug: placebo
Primary outcomes (1)
- measure
- The reduction in percent days on which HHV-8 is detected on versus off valganciclovir. The quantitative reduction in the HHV-8 DNA detected by PCR on versus off valganciclovir.
- timeFrame
- 19 weeks
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years or older * HHV-8 seropositive or previous evidence of HHV-8 shedding * a frequent shedder of HHV-8 * not receiving any drugs with known anti-HHV-8 activity for study duration * able to comply with the study protocol * agree to HIV testing Exclusion Criteria: * history of evidence of CMV disease * hypersensitivity to ganciclovir or valganciclovir * use of high-dose acyclovir, valacyclovir, famciclovir, ganciclovir, foscarnet, or cidofovir * neutropenia * renal insufficiency with serum creatinine greater than 1.5mg.ml or CrCl less than 60 * AST or ALT greater than 5 times upper limit of normal * concurrent administration of medications which are often associated with severe neutropenia or thrombocytopenia * concurrent administration of probenecid or didanosine
References
Publications (0)
Data not yet available
No reference posted for this study.