Testing a new dose of HIV medicines for children
Pharmacokinetic Study of an Optimized Dose Ratio of Dolutegravir/Emtricitabine/Tenofovir Alafenamide Fumarate: Expediting a UNIVERSAL First Line Regimen for All Children Living With HIV in Africa
This study is testing a new combination of HIV medicines in children to see if it’s safe and effective for them.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 28 Days to 10 Years |
| Sex | All |
| Sponsor | PENTA Foundation Research network |
| Locations | 3 sites (Kampala and 2 other locations) |
| Trial ID | NCT05993767 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of a novel dose ratio of three anti-HIV medications—dolutegravir (DTG), emtricitabine (FTC), and tenofovir alafenamide (TAF)—in children living with HIV. It aims to determine if this combination can achieve adequate drug concentrations in the body while being safe for young patients. The study will involve 50 children aged 28 days to less than 10 years, who will receive the treatment and undergo clinical assessments and blood tests over a 24-week period. The ultimate goal is to develop a fixed-dose combination dispersible tablet for easier administration to children and adults alike.
Who should consider this trial
Good fit: Ideal candidates are children aged 28 days to less than 10 years who weigh between 3 to less than 25 kg and have confirmed HIV-1 infection.
Not a fit: Patients outside the specified age and weight range, or those not confirmed to have HIV-1 infection, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a safer and more effective treatment option for children living with HIV.
How similar studies have performed: Other studies have shown success with similar approaches in adult populations, but this specific combination and dosing for children is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 28 days and 10 years old * Weighing 3 to \<25 kg * Confirmed HIV-1 infection (local, molecular methods) * A parent or legal guardian is willing and able to give informed consent on behalf of the child as per national legislation and willing to adhere to the protocol * Participant is willing to give informed assent if the trial site clinician deems them old enough and able to understand the age-appropriate information about participation in the study * Girls who have reached menarche must have a negative pregnancy test at screening * Subject is willing to start DTG/FTC/TAF regimen in the novel dose ratio for HIV treatment * Subjects already on a DTG-based ART regimen should be virologically suppressed at screening Exclusion Criteria: * Age between 28 days and 10 years old * Weighing 3 to \<25 kg * Confirmed HIV-1 infection (local, molecular methods) * A parent or legal guardian is willing and able to give informed consent on behalf of the child as per national legislation and willing to adhere to the protocol * Participant is willing to give informed assent if the trial site clinician deems them old enough and able to understand the age-appropriate information about participation in the study * Girls who have reached menarche must have a negative pregnancy test at screening * Subject is willing to start DTG/FTC/TAF regimen in the novel dose ratio for HIV treatment * Subjects already on a DTG-based ART regimen should be virologically suppressed at screening * History or presence of known allergy to DTG, FTC or TAF * Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN), OR ALT ≥3xULN AND bilirubin ≥2xULN * Patients with severe hepatic impairment or unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) * Current or anticipated need for TB therapy during the study * Use of rifampicin-based therapy within 4 weeks before start trial * Presence of comedication known to interact with trial medications * Known resistance to INSTI or NRTI
Where this trial is running
Kampala and 2 other locations
- Baylor College of Medicine Children's Foundation — Kampala, Uganda (Recruiting)
- Joint Research Centre — Kampala, Uganda (Recruiting)
- University of Zimbabwe Clinical Research Centre — Harare, Zimbabwe (Recruiting)
Study contacts
- Study coordinator: Alessandra Nardone
- Email: alessandra.nardone@pentafoundation.org
- Phone: +39 049 716 9822
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.