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Antiretroviral

Dolutegravir + Rilpivirine for HIV

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 up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dolutegravir(DTG)/Rilpivirine (RPV)Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCIndustry Sponsor
1,008 Previous Clinical Trials
6,402,883 Total Patients Enrolled
ViiV HealthcareLead Sponsor
375 Previous Clinical Trials
470,762 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorViiV Healthcare
3,608 Previous Clinical Trials
6,145,444 Total Patients Enrolled
~10 spots leftby Jun 2026
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