Empirical Treatment Against Cytomegalovirus and Tuberculosis in HIV-infected Infants With Severe Pneumonia

Summary

This trial will evaluate whether empirical treatment against cytomegalovirus and tuberculosis improves survival of HIV-infected infants with severe pneumonia.

Conditions

• Pneumonia
• HIV/AIDS
• Tuberculosis
• Cytomegalovirus Infections

Interventions

DRUG

Valganciclovir Oral Solution [Valcyte]

Treatment for CMV

DRUG

Tuberculostatic Agents

Treatment for tuberculosis

Sponsors & Collaborators

• University Hospital, Bordeaux

  collaborator OTHER

• Institut National de la Santé Et de la Recherche Médicale, France

  collaborator OTHER_GOV

• PENTA Foundation

  collaborator NETWORK

• Centre Hospitalier Cocody

  collaborator UNKNOWN

• Malawi-Liverpool-Wellcome Trust Clinical Research Programme

  collaborator OTHER

• Eduardo Mondlane University

  collaborator OTHER

• Centro de Investigação em Saúde de Manhiça

  collaborator OTHER

• Stichting Katholieke Universiteit

  collaborator OTHER

• Barcelona Institute for Global Health

  collaborator OTHER

• University of Lincoln

  collaborator OTHER

• Makerere University

  collaborator OTHER

• University Teaching Hospital, Lusaka, Zambia

  collaborator OTHER

• University of Zimbabwe

  collaborator OTHER

• Kamuzu Central Hospital

  collaborator OTHER

• Servicio Madrileño de Salud, Madrid, Spain

  collaborator OTHER

• Hospital Universitario 12 de Octubre

  lead OTHER

Principal Investigators

• Cinta Moraleda, MD, PhD · Fundación para la Investigación Biomédica del Hospital 12 de Octubre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

28 Days

Max Age

365 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-03-01

Primary Completion

2025-01-31

Completion

2025-01-31

Countries

• Côte d’Ivoire
• France
• Italy
• Malawi
• Mozambique
• Netherlands
• Spain
• Uganda
• United Kingdom
• Zambia
• Zimbabwe

Study Locations