ValgaNciclovIR for CMV Viraemia in AdvaNced HIV diseAse

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

Interventions

DRUG

Valganciclovir

Valganciclovir

DRUG

Placebo

Placebo

Sponsors & Collaborators

• Infectious Diseases Institute, Uganda

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• St George's, University of London

  collaborator OTHER

• Wits Health Consortium (Pty) Ltd

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-01

Primary Completion

2027-02-28

Completion

2027-06-30