Evaluating Dolutegravir in HIV-exposed Newborns
Open Label, Single Arm, Two-stage Trial to Evaluate the Single and Multi-dose Pharmacokinetics and Safety of the Paediatric Dolutegravir (10 mg, Scored) Dispersible Tablet in HIV-exposed Neonates
This study is testing if a new HIV medication called Dolutegravir is safe and effective for newborns who were exposed to HIV at birth.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 1 Day to 14 Days |
| Sex | All |
| Sponsor | Desmond Tutu TB Centre Academic / other |
| Locations | 1 site (Cape Town, Western Cape) |
| Trial ID | NCT05590325 on ClinicalTrials.gov |
What this trial studies
This Phase I/II trial aims to assess the pharmacokinetics and safety of Dolutegravir (DTG) in HIV-exposed neonates who are on antiretroviral prophylaxis. The study will enroll term neonates born to mothers with HIV who are receiving DTG-based therapy, with a focus on those with a birth weight of 2000 grams or more. Participants will be divided into two stages, where the first stage evaluates a single dose of DTG, and the second stage assesses multiple doses. The trial will monitor the infants for safety and efficacy during the first 28 days of life.
Who should consider this trial
Good fit: Ideal candidates include HIV-exposed neonates born to mothers on DTG-based antiretroviral therapy with a birth weight of 2000 grams or more.
Not a fit: Patients who are less than 37 weeks gestational age at birth or have known blood group incompatibilities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safe and effective treatment option for HIV-exposed neonates, potentially reducing the risk of HIV transmission.
How similar studies have performed: Other studies have shown promise in evaluating antiretroviral therapies in neonates, but this specific approach with Dolutegravir is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Stage 1: Inclusion Criteria * HIV-exposed neonate (pending HIV status) born to a woman within HIV on DTG-based ART * Birth weight of ≥2000 g and on standard of care ARV prophylaxis Cohort Specific Inclusion Criteria in Stage 1 must be met at Study Entry: Cohort 1A: Infant \<14 days of life Cohort 1B: Infant ≤3 days of life Stage 2: Inclusion Criteria * Low risk\* HIV-exposed neonate (pending HIV status) born to a virologically suppressed woman on DTG-based ART \*Neonate born to a woman with a documented plasma HIV-1 RNA result \<50 copies/mL in the 4 weeks prior to delivery or between delivery and infant study entry * Birth weight of ≥2000 g and on standard of care ARV prophylaxis Cohort Specific Inclusion Criteria in Stage 2 must be met at Study Entry: Cohort 2: Infant \<7 days of life Exclusion Criteria: * • Less than 37 weeks gestational age at birth * Known blood group incompatibilities which can result in hemolytic disease of the newborn (e.g., Rh-negative mother, presence of antibodies on neonatal red blood cells, etc.) * Total bilirubin values approaching an exchange transfusion as defined by local guidelines (Section 18.2) * Haemoglobin value of \<13.0 g/dL * Platelet count of less than 50,000 cells/mm3) * Decreased total white blood cell count (Grade 3 and above) * Creatinine value more than 1.3 the upper limit of normal (ULN) for gestational age and postnatal age (Grade 2 and above) * AST or ALT of more than 2.5 the ULN (Grade 2 and above) * Any other current Grade ≥3 event on the DAIDS toxicity table * Severe congenital abnormalities or critically ill neonates at discretion of the examining clinician * Receiving medicine(s) that can impact DTG pharmacokinetics (Section 8.7) * Participation in another clinical trial * HIV-infected neonates
Where this trial is running
Cape Town, Western Cape
- Tygerberg Hospital — Cape Town, Western Cape, South Africa (Recruiting)
Study contacts
- Principal investigator: Adrie Bekker, Prof — University of Stellenbosch
- Study coordinator: Adrie Bekker, Prof
- Email: adrie@sun.ac.za
- Phone: +27 (0)219389198
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.