Dolutegravir 5 mg Dispersible Tablets for HIV

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
IMPAACT/ Gamma Project/ UPR Pediatric HIV/AIDS Research CRS, San Juan, Puerto Rico
HIV
Dolutegravir 5 mg Dispersible Tablets - Drug
Eligibility
Any Age
All Sexes
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Study Summary

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.

Treatment Effectiveness

Study Objectives

5 Primary · 2 Secondary · Reporting Duration: 28 months

28 months
AUC(0-tau) for DTG
Area under the curve (AUC) for DTG
Association of UGT1A1 gene sequence variants with DTG CL/F
C(last) for DTG
C(trough) for DTG
Week 16
Proportion of infants classified as "study drug-related" safety failures.
Proportion of infants classified as safety failures.
Initial study drug dosing through study drug discontinuation
Proportion of infants who are not able to tolerate the study drug.

Trial Safety

Trial Design

2 Treatment Groups

Cohort 1
1 of 2
Cohort 2
1 of 2
Experimental Treatment

36 Total Participants · 2 Treatment Groups

Primary Treatment: Dolutegravir 5 mg Dispersible Tablets · No Placebo Group · Phase 1

Cohort 1Experimental Group · 2 Interventions: Dolutegravir 0.5 mg/kg oral suspension, Dolutegravir 5 mg Dispersible Tablets · Intervention Types: Drug, Drug
Cohort 2Experimental Group · 2 Interventions: Dolutegravir 0.5 mg/kg oral suspension, Dolutegravir 5 mg Dispersible Tablets · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 28 months
Closest Location: Bronx-Lebanon Hospital Center NICHD CRS · Bronx, NY
Photo of Bronx 1Photo of Bronx 2Photo of Bronx 3
2014First Recorded Clinical Trial
0 TrialsResearching HIV
9 CompletedClinical Trials

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,785 Previous Clinical Trials
2,221,762 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,490 Previous Clinical Trials
1,766,035 Total Patients Enrolled
ViiV HealthcareIndustry Sponsor
332 Previous Clinical Trials
462,094 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,108 Previous Clinical Trials
4,672,408 Total Patients Enrolled
Diana Clarke, Pharm.D.Study ChairBMC/Dept. of Pharmacy

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Infants born to mothers who received DTG within 72 hours of delivery.\n
You are 37 weeks or more gestational age at birth.\n
At least 2 kilograms of body weight.
At least 3 kilograms of body weight.\n
You are of legal age or circumstance to provide independent informed consent and are willing and able to provide written informed consent for your infant's participation in this study.
For results obtained from medical records, adequate source documentation, including the date of specimen collection, date of testing or date of test result, name of test/assay performed, and test result, must be available in study records prior to study entry.
Infants born to mothers who received DTG during the two weeks immediately prior to delivery.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.