Antiretroviral

Dolutegravir + Rilpivirine for HIV

Washington, United States

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.

See full description

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.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.