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Antiretroviral

Dolutegravir(DTG)/Rilpivirine (RPV) for Human Immunodeficiency Virus Infection

Phase 1 & 2

Recruiting

Research Sponsored by ViiV Healthcare

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 baseline (day 1), week 4, 8, 12, 16, 20, 24, 36 and 48

Awards & highlights

Study Summary

This trial aims to gather information on how well a new 2-drug combination tablet works in children aged 6 to 12 years who have HIV and have their viral levels under control.

Who is the study for?

This trial is for HIV-1 infected children aged 6 to less than 12 years, weighing at least 25 kg. They must have been on the same antiretroviral therapy for the past six months and have a viral load of less than 50 copies/mL. Participants should not be pregnant or breastfeeding and if of reproductive potential, agree to use two contraception methods.Check my eligibility

What is being tested?

The study tests the pharmacokinetics (how the drug moves through a child's body), safety, tolerability, efficacy, and acceptability of Dolutegravir/Rilpivirine in tablet form for kids who are already responding well to HIV treatment.See study design

What are the potential side effects?

Possible side effects may include trouble sleeping, headache, depression or mood changes; digestive issues like stomach pain or discomfort; weight gain; rash or allergic reactions; muscle pain; tiredness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 1), week 4, 8, 12, 16, 20, 24, 36 and 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day 1), week 4, 8, 12, 16, 20, 24, 36 and 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1), week 4, 8, 12, 16, 20, 24, 36 and 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area under the curve (AUC0-24h) of DTG

Area under the curve (AUC0-24h) of RPV

Number of Participants with AEs assessed as related to study drug that led to permanent discontinuation of study drug at Week 24

+5 more

Secondary outcome measures

Cluster of differentiation 4 (CD4+) Cell Count

Cmin of DTG at Week 4 Visit

Cmin of RPV

+16 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dolutegravir(DTG)/Rilpivirine (RPV)Experimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCIndustry Sponsor

976 Previous Clinical Trials

6,384,672 Total Patients Enrolled

ViiV HealthcareLead Sponsor

360 Previous Clinical Trials

468,559 Total Patients Enrolled

GSK Clinical TrialsStudy DirectorViiV Healthcare

3,595 Previous Clinical Trials

6,143,920 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for patient participation in this clinical trial?

"The ongoing trial, currently open for enrollment according to clinicaltrials.gov, was initially listed on 7/6/2023 and its latest update was recorded on 3/27/2024."

Answered by AI

Who meets the eligibility criteria to participate in this medical study?

"Participants aged between 6 and 12 years old with a confirmed human immunodeficiency virus infection are sought to fill the 20 available slots for this clinical trial."

Answered by AI

Is the research suitable for those individuals who are younger than 70 years old?

"Eligible participants for this research study must be between 6 and 12 years old based on the inclusion criteria."

Answered by AI

What is the upper limit for the participation count in this medical study?

"Affirmative. The details from clinicaltrials.gov indicate that this medical research is actively seeking participants. Initially shared on July 6, 2023, the trial data was last updated on March 27, 2024. A total of 20 volunteers are sought across seven locations."

Answered by AI

In North America, are there numerous medical facilities conducting this trial?

"The ongoing trial is operational at 7 sites, including establishments in Washington, Fort Lauderdale, and Miami among others. Opting for the site closest to you will reduce the need for extensive travel should you decide to partake in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics

2023. "Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05674656.