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

NCT ID NCT03915366

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

563 people

The number who actually took part.

Started

Mar 2020

Finished

Jan 2025

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

28 to 365 days

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: 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

  • 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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