Your session is about to expire
← Back to Search
Antiretroviral
The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age
Phase 1 & 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1; blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing.
Awards & highlights
No Placebo-Only Group
Summary
This trial studied the effects of a new HIV drug in children. The drug was found to be safe and effective in treating HIV in children.
Eligible Conditions
- HIV Suppression
- Human Immunodeficiency Virus Infection
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 1; blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1; blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Geometric Mean Area Under the Plasma Concentration-time Curve Over 24 Hours (AUC0-24h) for ABC, DTG, and 3TC
Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC
Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC
+6 moreSecondary study objectives
Antiretroviral (ARV) Resistance Mutations
Median (Q1, Q3) CD4+ Cell Count
Median (Q1, Q3) CD4+ Percentage
+38 moreSide effects data
From 2022 Phase 1 & 2 trial • 57 Patients • NCT0376045864%
Glomerular filtration rate decreased
45%
Blood creatinine increased
27%
Neutropenia
18%
Aspartate aminotransferase increased
18%
Cough
18%
Blood cholesterol increased
18%
Rhinorrhoea
9%
Ligament sprain
9%
Childhood asthma
9%
Wheezing
9%
Pharyngitis
9%
Blood triglycerides increased
9%
Haemoglobin decreased
9%
Low density lipoprotein increased
9%
Oropharyngeal pain
9%
Perioral dermatitis
9%
Lymphadenopathy
9%
Hepatomegaly
9%
COVID-19
9%
Alanine aminotransferase increased
9%
Platelet count decreased
9%
Headache
9%
Dyspnoea exertional
9%
Upper respiratory tract congestion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Weight Band #5 (25 kg or Greater at Study Entry)
Weight Band #3 (14 to Less Than 20 kg at Study Entry)
Weight Band #4 (20 to Less Than 25 kg at Study Entry)
Weight Band #1 (6 to Less Than 10 kg at Study Entry)
Weight Band #2 (10 to Less Than 14 kg at Study Entry)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Group I: Weight Band #5 (25 kg or greater at study entry)Experimental Treatment1 Intervention
Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.
Group II: Weight Band #4 (20 to less than 25 kg at study entry)Experimental Treatment1 Intervention
Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.
Group III: Weight Band #3 (14 to less than 20 kg at study entry)Experimental Treatment1 Intervention
Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.
Group IV: Weight Band #2 (10 to less than 14 kg at study entry)Experimental Treatment1 Intervention
Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.
Group V: Weight Band #1 (6 to less than 10 kg at study entry)Experimental Treatment1 Intervention
Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets
2020
Completed Phase 2
~60
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release)
2020
Completed Phase 2
~60
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,336 Previous Clinical Trials
5,392,707 Total Patients Enrolled
International Maternal Pediatric Adolescent AIDS Clinical Trials GroupNETWORK
34 Previous Clinical Trials
11,862 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,068 Previous Clinical Trials
2,747,650 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,936 Previous Clinical Trials
2,751,584 Total Patients Enrolled
ViiV HealthcareIndustry Sponsor
375 Previous Clinical Trials
470,711 Total Patients Enrolled
Patricia Flynn, MDStudy ChairSt. Jude Children's Research Hospital
4 Previous Clinical Trials
433 Total Patients Enrolled
Helena Rabie, MBChB, MMED, FCPaedStudy ChairUniversity of Stellenbosch
Jennifer Kiser, PharmD, PhDStudy ChairUniversity of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences