ValgaNciclovIR for CMV Viraemia in AdvaNced HIV diseAse

NCT07379203 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: NIRVANA
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn if valganciclovir works to treat cytomegalovirus (CMV) infection in people with advanced HIV disease. It will also look at the safety of valganciclovir and how the body handles the drug. The main questions this study aims to answer are: Does valganciclovir safely lower the amount of CMV virus in the blood of people with advanced HIV disease? What medical problems or side effects do participants have when taking valganciclovir? Researchers will compare valganciclovir to a placebo (a look-alike tablet that does not contain any active drug) to see if valganciclovir works better than no treatment for CMV. Who can take part Adults and adolescents (15 years and older) who: Are living with HIV Have a CD4 count of 100 or less (meaning their immune system is very weak) Have CMV detected in their blood People who are pregnant, breastfeeding, very unwell, or have certain blood or kidney problems cannot take part. What will happen in the study Participants will: Be randomly assigned (like flipping a coin) to take either valganciclovir 900 mg or a placebo once a day for 4 weeks Continue to receive standard medical care for HIV and any other infections Be followed for 12 weeks after starting the study treatment During this time, participants will: Have blood tests to check CMV, HIV, and general health Have regular medical check-ups (daily in hospital, then at weeks 1, 2, 3, 4, 8, and 12) Be monitored closely for side effects, such as low blood counts or kidney problems Why this study is important Even though HIV treatment is widely available, many people still come to hospital with advanced HIV disease. In this group, about one in five people die despite starting antiretroviral therapy (ART). Reactivation of CMV is very common in these patients and has been linked to a higher risk of death. Valganciclovir is a medicine that stops CMV from multiplying. If it proves to be safe and effective in this study, it could become part of routine care to help reduce deaths in people with advanced HIV disease. Study design Type: Phase 2b, double-blind, randomised, placebo-controlled trial Sites: Helen Joseph Hospital (South Africa) and Mulago National Referral Hospital (Uganda) Number of participants: 150 (130 in the main trial, 20 in a smaller sub-study) Duration: Each participant will be followed for 12 weeks; total study duration about 2 years Possible risks and benefits Risks: Valganciclovir can cause low white blood cells, anaemia, or low platelets. These effects will be checked for regularly, and treatment will be stopped if unsafe levels are found. Benefits: The study may or may not directly benefit participants. However, it could provide important information that helps improve care for people with advanced HIV disease in the future. Oversight and safety The study is being conducted by researchers in Uganda, South Africa, the UK, and the USA, and follows international Good Clinical Practice (GCP) guidelines. An independent Data Safety and Monitoring Committee (DSMC) will regularly review safety information to protect participants.

Conditions

Cytomegalovirus (CMV) Infection

Keywords

Cytomegalovirus; Advanced HIV disease; valganciclovir

Outcome Measures

Primary Outcomes (1)

• Adverse events of special interest plus re-hospitalisation or death up to week 8

  Adverse Events of Special Interest• Absolute neutrophil count \< 0.4 X109/L * Haemoglobin \< 7 g/dL * Platelets \< 50 X109/L * Creatinine increases to \> 1.5X participant's baseline * ALT \> 5X ULN

  8 weeks post randomisation

Study Arms (2)

Valganciclovir

EXPERIMENTAL

Valganciclovir 900mg daily for 28 days

Drug: Valganciclovir

Arm B

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Valganciclovir DRUG

Valganciclovir

Valganciclovir

Placebo DRUG

Placebo

Arm B

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed HIV infection CD4 count ≤100 cells/mm³ Expected to survive at least 48 hours CMV viral load \>500 international units (IU) / mL in blood. Provision of informed consent

You may not qualify if:

• Confirmed or high level of clinical suspicion for CMV end organ disease as determined by the treating team CMV retinitis confirmed by retinal phography Pregnancy or breastfeeding Contraindication to valganciclovir (absolute neutrophil count \< 1.0 X109/L, haemoglobin \< 8 g/dL, platelets \< 100 X109/L) Allergy or prior adverse reaction to valganciclovir Expected to be unable to complete follow up Moribund - treating team considers patient is likely to die within next 48 hours Estimated creatinine clearance \< 40 mL/min ALT \> 3X ULN Receipt of high dose acyclovir as standard of care Unable to swallow whole tablets Concurrent administration of highly myelosuppressive drug, e.g. amphotericin B deoxycolate and linezolid

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: collaborator
• Wits Health Consortium (Pty) Ltd: lead
• Infectious Diseases Institute, Uganda: collaborator
• St George's, University of London: collaborator

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Valganciclovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Ganciclovir; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 30, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: August 2027 to July 2030
• Access Criteria: Reputable researchers