Dolutegravir for Newborns Exposed to HIV
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that infants or breastfeeding mothers should not be receiving any disallowed medication, so it's best to discuss your current medications with the study team.
What data supports the effectiveness of the drug Dolutegravir for newborns exposed to HIV?
Dolutegravir has been shown to be effective in managing HIV-1 infection in adolescents and adults, with studies indicating it works well even against some drug-resistant strains. It has been successfully used in children under 15 in Mozambique, showing good virological outcomes, which suggests it could be effective for newborns as well.12345
Is Dolutegravir safe for humans?
What makes the drug Dolutegravir unique for newborns exposed to HIV?
What is the purpose of this trial?
This study will test an anti-HIV drug (ARV) for newborn babies. The study will include a minimum of 36 and up to 108 mothers living with HIV and their newborn babies from Brazil, South Africa, Thailand, and the United States. Infants will be in the study for approximately 16 weeks (four months) after they are born. Mothers will not receive study drug and will exit the study after the Entry visit.
Research Team
Diana Clarke, Pharm.D.
Principal Investigator
BMC/Dept. of Pharmacy
Eligibility Criteria
This trial is for newborn babies exposed to HIV-1, born at least 37 weeks into pregnancy and weighing at least 2 kg. They must be generally healthy with normal or slightly altered blood tests. Babies can participate if their mothers have confirmed HIV-1 but haven't taken Dolutegravir close to delivery. Mothers need legal capacity to consent.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Infants receive the study drug Dolutegravir to evaluate pharmacokinetics and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Dolutegravir
Dolutegravir is already approved in European Union, United States, Canada, Japan, Switzerland for the following indications:
- HIV-1 infection
- HIV-1 infection
- HIV-1 infection
- HIV-1 infection
- HIV-1 infection
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
ViiV Healthcare
Industry Sponsor
Dr. Harmony Garges
ViiV Healthcare
Chief Medical Officer
MD
Deborah Waterhouse
ViiV Healthcare
Chief Executive Officer since 2017
Bachelor's degree in Business Administration
National Institute of Mental Health (NIMH)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator