Could early CMV and TB drugs save HIV-Positive babies with pneumonia?
NCT ID NCT03915366
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.
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
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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563 people
The number who actually took part.
- Started
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Mar 2020
- Finished
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Jan 2025
- Lead sponsor
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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
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28 to 365 days
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Age 28 days to 365 days of age 2. Pneumonia defined as chest indrawing or fast breathing for age, for infants 28 to 60 days of age ≥60 breaths per minute and for infants 61 to 365 days of age, ≥50 breaths per minute. 3. Current hospitalization due to pneumonia with criteria for parenteral antibiotics (1 or more criteria) 1. Chest indrawing with HIV infection 2. No improvement with oral treatment. 3. One or more danger signs according to WHO 5,44,45 * Central cyanosis or saturation of O2 \<90% * Severe respiratory distress, e.g. grunting or very severe chest indrawing * Signs of pneumonia with a general danger sign: * Unable to drink or breastfeed * Persisting vomiting * Convulsions in the last 24 hours * Lethargic or unconscious * Stridor while calm * Severe malnutrition 4. HIV-confirmed infection (with at least one molecular method: DNA polymerase chain reaction (PCR) or RNA PCR/viral load). 5. Informed consent obtained Exclusion Criteria: 1. Clinical TB (pulmonary or extrapulmonary) diagnosis, defined as the necessity of TB-T prescribed by a physician, at the moment of randomization 2. Known bacteriologically confirmed TB case (at least one biological specimen positive by culture or Xpert MTB/RIF) at the moment of randomization 3. Patient previously treated for TB or currently on treatment for TB 4. Documented evidence of close TB exposure (household contact of a patient with documented TB during the lifetime of the child, or currently receiving TB-T) 5. Pure wheezers defined as a clear clinical improvement after a bronchodilator test (give a challenge of rapid-acting inhaled bronchodilator for up to three times 15-20 minutes apart. Count the breaths and look for chest indrawing again, and then re-classify) 6. Active malignancies 7. Systemic immunosuppressive medications. Steroids will be considered to be immunosuppressing only if \>2 mg/kg of prednisone or equivalent during \>15 days 8. Evidence of condition other than HIV and pneumonia which precludes, to the judgment of the clinical researcher, enrollment in this trial due to risk for the patient. In case of doubt, the Trial Management Team will be contacted to assess eligibility 9. Less than 2.5 kg of weight 10. Hb \<6 g/dL in the screening blood test or in a test done in the last 48 hours. Transfusion is permitted to achieve \>6 g/dL if the patient's state allows it. In case a transfusion is administered, the patient can be enrolled 11. Neutropenia \<500 /mm3 in the screening blood test or in a test done in the last 48 hours. Repeating the test is allowed to check eligibility
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cemtro de Investigaçao em Saúde da Manhiça
Manhiça, Mozambique
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Fundación para la Investigación Biomédica del Hospital 12 de Octubre
Madrid, 28041, Spain
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Hospital Central Maputo
Maputo, Mozambique
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INSERM
Toulouse, France
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Lusaka Teaching Hospital
Lusaka, Zambia
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Makerere University - Mulago Hospital
Kampala, Uganda
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Malawi Liverpool Welcome Trust. Queen Elizabeth Central Hospital College of Medicine
Blantyre, Malawi
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PENTA Foundation
Padova, Italy
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Programme PACCI. Centre Hospitalier Cocody.
Abidjan, Côte d’Ivoire
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Stichting Katholieke Universiteit Radboudumc
Nijmegen, Netherlands
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University of Lincoln
Lincoln, United Kingdom
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University of Zimbabwe Clinical Research Centre
Harare, Zimbabwe
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Université de Bourdeaux
Bourdeaux, France
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