CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 563 enrolled
Drug / intervention
Valganciclovir Oral Solution [Valcyte] +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03915366
NCT03915366Phase 3Completed
CompareCT.gov

Empirical Treatment Against Cytomegalovirus and Tuberculosis in HIV-infected Infants With Severe Pneumonia: a Multicenter, Open-label Randomized Controlled Clinical Trial

Hospital Universitario 12 de Octubre·interventional·Posted Apr 16, 2019·Updated Sep 19, 2025

In Brief

A Phase 3 clinical trial evaluating Valganciclovir Oral Solution [Valcyte] and Tuberculostatic Agents for Pneumonia and 3 related conditions. Completed, enrolled 563 participants across 13 sites in 11 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumonia, HIV/AIDS, Tuberculosis, Cytomegalovirus Infections
CountriesCôte d’Ivoire, France, Italy, Malawi, Mozambique, Netherlands, Spain, Uganda, United Kingdom, Zambia, Zimbabwe
CollaboratorsUniversity Hospital, Bordeaux, Institut National de la Santé Et de la Recherche Médicale, France, PENTA Foundation, Centre Hospitalier Cocody, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Eduardo Mondlane University, Centro de Investigação em Saúde de Manhiça, Stichting Katholieke Universiteit, Barcelona Institute for Global Health, University of Lincoln, Makerere University, University Teaching Hospital, Lusaka, Zambia, University of Zimbabwe, Kamuzu Central Hospital, Servicio Madrileño de Salud, Madrid, Spain

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedApr 16, 2019
Enrollment StartMar 1, 2020
Primary CompletionJan 31, 2025
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 7.2 years ago

Interventions

Valganciclovir Oral Solution [Valcyte]drug

Treatment for CMV

Tuberculostatic Agentsdrug

Treatment for tuberculosis