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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Parent or legal guardian or participant >=18 years of age is able and willing to provide signed informed consent.
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial is for children who participated in previous studies on the effects of dolutegravir, a medication used to treat HIV, and who can no longer access the medication. The trial will provide the medication to the children until it is available to them again. Up to 300 children may be enrolled.
Who is the study for?
This trial is for children and adolescents who have HIV-1 and were part of previous studies P1093 or P2019. They must show benefits from the prior treatments without significant side effects or virologic failure. Participants need to practice safe sex, and females of childbearing age must use birth control.Check my eligibility
What is being tested?
The study tests ongoing effectiveness of Dolutegravir-based treatments (ABC/DTG/3TC) in tablet forms for pediatric patients with HIV-1. It's an open-label, phase 3b trial providing continued access to these drugs until they're publicly available.See study design
What are the potential side effects?
Possible side effects include allergic reactions, blood disorders like low neutrophil count or hemoglobin, liver issues indicated by elevated enzymes, pancreatitis symptoms, and potential drug interactions leading to increased toxicity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I, or my guardian if I'm under 18, can and will sign the consent form.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with continued access to age appropriate formulation of dolutegravir
Secondary outcome measures
Number of participants with SAEs based on the severity
Number of participants with any clinical or laboratory adverse events leading to discontinuation of investigational product
Number of participants with serious adverse events (SAEs) as a measure of safety
Trial Design
2Treatment groups
Experimental Treatment
Group I: Dolutegravir (Tivicay)Experimental Treatment2 Interventions
All participants will receive dolutegravir film-coated tablets or film-coated dispersible tablets at appropriate doses selected as per their age and weight bands. For those participants who were previously receiving dolutegravir in study P1093 (parent study), dolutegravir will be supplied as film-coated tablets containing 50 mg; and 5 mg film-coated dispersible tablets of dolutegravir. Participants will receive dolutegravir until age-appropriate formulations are available to them from some other source, or until participant is no longer deriving benefit from treatment, or participant is discontinued, or until development of dolutegravir is terminated.
Group II: ABC/DTG/3TCExperimental Treatment2 Interventions
All participants will receive ABC/DTG/3TC immediate release tablets or film-coated dispersible tablets at appropriate doses selected as per their weight bands. For those participants who were previously receiving ABC/DTG/3TC in study P2019 (parent study), ABC/DTG/3TC will be supplied as immediate release tablets containing 600 mg, 50 mg and 300 mg of ABC, DTG, and 3TC respectively and film-coated dispersible tablets containing 60 mg, 5 mg and 30 mg of ABC, DTG, and 3TC respectively. Participants will receive ABC/DTG/3TC until age-appropriate formulations are available to them from some other source, until participant is no longer deriving benefit from treatment, or until participant is discontinued, or until development of ABC/DTG/3TC is terminated.
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Who is running the clinical trial?
ViiV HealthcareLead Sponsor
360 Previous Clinical Trials
468,478 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorViiV Healthcare
3,595 Previous Clinical Trials
6,143,829 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver function tests are within normal limits and I do not have severe liver problems.I, or my guardian if I'm under 18, can and will sign the consent form.My HIV treatment with DTG, ABC, or 3TC failed due to drug resistance.I am not pregnant, planning to become pregnant, or breastfeeding during the study.I am not taking any medications that are not allowed in this study.I practice safe sex and understand the risks of HIV transmission.I agree to use birth control and condoms during the study if I can get pregnant.I am HLA-B*5701 positive and was in the P2019 study taking ABC/DTG/3TC.I do not have any active infections related to AIDS.I have been diagnosed with pancreatitis by my doctor.I do not have severe lab test abnormalities from previous studies.I might need treatment for Hepatitis C that could interfere with the study's treatment.
Research Study Groups:
This trial has the following groups:- Group 1: ABC/DTG/3TC
- Group 2: Dolutegravir (Tivicay)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any side effects associated with taking ABC/DTG/3TC immediate release tablets?
"There is some evidence, from both Phase 3 trials and other sources, that suggests ABC/DTG/3TC immediate release tablets are safe."
Answered by AI
Are there other published reports on the effects of ABC/DTG/3TC immediate release tablets?
"ABC/DTG/3TC was first studied at University of Zurich in 2002 and, to date, there have been 98 completed studies. Currently, there are 34 live studies; many of which are based in Los Angeles, California."
Answered by AI
If I am interested in enrolling in this clinical trial, are there opportunities available?
"Yes, this study is still looking for volunteers according to the most recent update on clinicaltrials.gov. The posting date was June 6th, 2017."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
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