Could early CMV and TB drugs save HIV-Positive babies with pneumonia?

NCT ID NCT03915366

Completed Disease control Sponsor: Hospital Universitario 12 de Octubre Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether giving HIV-infected infants with severe pneumonia early treatment for cytomegalovirus (CMV) and tuberculosis (TB) could help them survive. Over 500 babies aged 1 month to 1 year were randomly assigned to receive either standard care or additional drugs for CMV and TB. The main goal was to see if this approach reduced deaths within 15 days and up to one year.

What this could mean

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

Active substance: Valganciclovir and tuberculosis drugs
What this could lead to: If successful, this approach could reduce deaths in HIV-positive infants with severe pneumonia by treating hidden CMV and TB infections early.
What could go wrong: This is a completed Phase 2/3 trial, but results may not apply to all settings. The drugs have side effects, and the benefit may be limited to specific populations.

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Conditions

The condition(s) this trial relates to.

AIDS cytomegalovirus infection HIV infectious disease pneumonia tuberculosis

As listed by the trial registrant

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

CYTOMEGALOVIRUS INFECTIONS HIV/AIDS PNEUMONIA TUBERCULOSIS

Contacts and locations

Locations

Cemtro de Investigaçao em Saúde da Manhiça

Manhiça, Mozambique
Fundación para la Investigación Biomédica del Hospital 12 de Octubre

Madrid, 28041, Spain
Hospital Central Maputo

Maputo, Mozambique
INSERM

Toulouse, France
Lusaka Teaching Hospital

Lusaka, Zambia
Makerere University - Mulago Hospital

Kampala, Uganda
Malawi Liverpool Welcome Trust. Queen Elizabeth Central Hospital College of Medicine

Blantyre, Malawi
PENTA Foundation

Padova, Italy
Programme PACCI. Centre Hospitalier Cocody.

Abidjan, Côte d’Ivoire
Stichting Katholieke Universiteit Radboudumc

Nijmegen, Netherlands
University of Lincoln

Lincoln, United Kingdom
University of Zimbabwe Clinical Research Centre

Harare, Zimbabwe
Université de Bourdeaux

Bourdeaux, France

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