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Can a common antiviral save lives in advanced HIV?

NCT ID NCT07379203

Disease control Sponsor: Wits Health Consortium (Pty) Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether valganciclovir, a drug that stops CMV from multiplying, can safely lower CMV levels in the blood of people with advanced HIV. About 130 adults and adolescents with very weak immune systems will be randomly assigned to take either valganciclovir or a placebo daily for 4 weeks, while continuing standard HIV care. Researchers will monitor side effects and check if the drug reduces hospitalizations or deaths.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Valganciclovir
What this could lead to
If it works, this could point toward a standard treatment to reduce CMV-related deaths in people with advanced HIV.
What could go wrong
This is a phase 2b trial with only 130 participants, so results may not apply broadly. Valganciclovir can cause serious side effects like low blood cell counts.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 130 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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 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 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 \-

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Conditions

The condition(s) this trial relates to.

AIDS cytomegalovirus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cytomegalovirus (CMV) infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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