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Integrase Inhibitor
Dolutegravir for HIV-1 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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one intensive pk visit between 5 and 10 days of dtg initiation. at intensive pk visit, blood samples were drawn pre-dose and at 1, 2, 3, 4, 6, 8 and 24 hours post dosing
Awards & highlights
Summary
This trial found that DTG is safe and effective when used with OBT in HIV-1 infected infants, children, and adolescents.
Who is the study for?
This trial is for HIV-1 infected infants, children, and adolescents who have a viral load greater than 1,000 copies/mL. Participants can be ARV treatment-experienced or naive but must not have resistance to integrase inhibitors or any history of malignancy. They should be able to swallow medication and commit to the study's procedures.Check my eligibility
What is being tested?
The trial tests Dolutegravir (DTG) in various forms (film-coated tablets, granules for suspension, dispersible tablets) alongside optimized background therapy in young patients with HIV-1. It aims to assess drug safety, tolerability, immune response and how the body processes it.See study design
What are the potential side effects?
Potential side effects may include digestive issues like nausea or vomiting; allergic reactions; changes in liver function; fatigue; headaches; difficulty sleeping; and possible effects on growth rates or development in children.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one intensive pk visit between 5 and 10 days of dtg initiation. at intensive pk visit, blood samples were drawn pre-dose and at 1, 2, 3, 4, 6, 8 and 24 hours post dosing
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one intensive pk visit between 5 and 10 days of dtg initiation. at intensive pk visit, blood samples were drawn pre-dose and at 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
PK Parameter: Area-under-the-curve From 0 to 24 Hours (AUC0-24)
Secondary outcome measures
Disease Progression as Measured by Change in Centers for Disease Control and Prevention (CDC) Category
Genotypic and Phenotypic Measures of Resistance
Number of Participants Who Died
+16 moreTrial Design
8Treatment groups
Experimental Treatment
Group I: Cohort V-DTExperimental Treatment1 Intervention
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets
Group II: Cohort IV-DTExperimental Treatment1 Intervention
Children 6 months to younger than 2 years of age who received DTG dispersible tablets
Group III: Cohort IVExperimental Treatment1 Intervention
Children 6 months to younger than 2 years of age who received DTG granules for suspension
Group IV: Cohort III-DTExperimental Treatment1 Intervention
Children 2 to younger than 6 years of age who received DTG dispersible tablets
Group V: Cohort IIIExperimental Treatment1 Intervention
Children 2 to younger than 6 years of age who received DTG granules for suspension
Group VI: Cohort IIBExperimental Treatment1 Intervention
Children 6 to younger than 12 years of age who received DTG granules for suspension
Group VII: Cohort IIAExperimental Treatment1 Intervention
Children 6 to younger than 12 years of age who received DTG film-coated tablets
Group VIII: Cohort IExperimental Treatment1 Intervention
Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DTG dispersible tablets
2011
Completed Phase 2
~190
DTG film-coated tablets
2011
Completed Phase 2
~190
DTG granules for suspension
2011
Completed Phase 2
~190
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,283 Previous Clinical Trials
5,498,751 Total Patients Enrolled
Andrew Wiznia, M.D.Study ChairJacobi Medical Center
Theodore Ruel, M.D.Study ChairUniversity of California, San Francisco
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had cancer before, but it doesn't count if it was just on your skin and was removed.You have signs or symptoms of pancreatitis, as determined by your doctor.The participant or their mother has taken integrase inhibitor medication before giving birth or stopping breastfeeding.You have taken HIV medications in the past, except if it was for preventing transmission to a baby or as a preventive measure.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort III
- Group 2: Cohort I
- Group 3: Cohort IIA
- Group 4: Cohort IIB
- Group 5: Cohort IV
- Group 6: Cohort III-DT
- Group 7: Cohort IV-DT
- Group 8: Cohort V-DT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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