The safety of valganciclovir in adults and adolescents with advanced HIV disease and cytomegalovirus viraemia

A phase 2b Randomised Placebo Controlled Trial of Valganciclovir for Cytomegalovirus Viraemia in adults and adolescents with Advanced HIV Disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

PACTR

Registry ID

PACTR202507522416399

Enrollment

130

Registered

2025-07-31

Start date

2025-08-04

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS

Interventions

Matching placebo

Valganciclovir IN WHAT WAY IS THIS VAGUE

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age =15 years Confirmed HIV infection CD4 count =100 cells/µL CMV viral load >500 IU/mL in blood. Provision of informed consent

Exclusion criteria

Exclusion criteria: Confirmed or high level of clinical suspicion for CMV end organ disease as determined by the treating team CMV retinitis confirmed by retinal photography Pregnancy or breastfeeding Contraindication to valganciclovir (absolute neutrophil count 3X upper limit of normal (ULN)

Design outcomes

Primary

Measure	Time frame
Adverse events of special interest plus re-hospitalisation or death	—

Secondary

Measure	Time frame
Adverse events of special interest plus re-hospitalisation or death ;Hospital length of stay post randomisation;Serious adverse events (SAEs) ;Mortality: Survival time and all-cause mortality;Median reduction in CMV viral load (log10 IU/mL) ;Proportion with CMV below the limit of detection ;Proportion of participants who prematurely discontinue trial medication ;Ganciclovir resistance: Genotypic resistance to ganciclovir at week 4 by sequencing the UL97 kinase UL54 DNA polymerase genes;Proportion with HIV viral suppression (< 50 copies/mL) stratified by ART status at baseline.;Ganciclovir pharmacokinetics	—

Measure

Time frame

Adverse events of special interest plus re-hospitalisation or death ;Hospital length of stay post randomisation;Serious adverse events (SAEs) ;Mortality: Survival time and all-cause mortality;Median reduction in CMV viral load (log10 IU/mL) ;Proportion with CMV below the limit of detection ;Proportion of participants who prematurely discontinue trial medication ;Ganciclovir resistance: Genotypic resistance to ganciclovir at week 4 by sequencing the UL97 kinase UL54 DNA polymerase genes;Proportion with HIV viral suppression (< 50 copies/mL) stratified by ART status at baseline.;Ganciclovir pharmacokinetics

—

Countries

South Africa, Uganda

Contacts

Public ContactSheila Stanford

Manager

sstanford@witshealth.co.za+27112768800

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026