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Antiretroviral
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets for Human Immunodeficiency Virus Infection
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
Weight 6 kg to less than 40 kg at entry
Antiretroviral therapy (ART)-naïve at entry or has been taking a stable ART regimen for at least six consecutive months at entry
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
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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%
Blood cholesterol increased
18%
Aspartate aminotransferase increased
18%
Cough
18%
Rhinorrhoea
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%
Ligament sprain
9%
Alanine aminotransferase increased
9%
Platelet count decreased
9%
Headache
9%
Childhood asthma
9%
Dyspnoea exertional
9%
Upper respiratory tract congestion
9%
Wheezing
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)
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
3,268 Previous Clinical Trials
5,480,643 Total Patients Enrolled
International Maternal Pediatric Adolescent AIDS Clinical Trials GroupNETWORK
34 Previous Clinical Trials
12,342 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,958 Previous Clinical Trials
2,673,458 Total Patients Enrolled
Frequently Asked Questions
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