DTG/3TC for HIV-1 in Adolescents

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: ViiV Healthcare

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests a new two-drug pill for HIV-infected adolescents who haven't had treatment before. The pill combines DTG and 3TC, which work together to stop the virus from multiplying. The goal is to see if this simpler treatment is effective and safe over time. Dolutegravir (DTG) and lamivudine (3TC) have shown high efficacy and tolerability in both new and experienced HIV-positive patients, and are recommended as an alternative to more complex treatments to reduce long-term toxicity and costs.

Eligibility Criteria

This trial is for HIV-1 infected adolescents aged 12 to under 18, weighing at least 25 kg, who have never been treated with antiretroviral drugs. Participants can join if they've had ART for preventing mother-to-child transmission or post/pre-exposure prophylaxis over six months ago. They must not be pregnant or breastfeeding and agree to use birth control.

Inclusion Criteria

I am a man or a woman capable of having children and meet specific conditions.

I or my guardian can sign the consent form.

Screening plasma HIV-1 RNA between 1,000 and <=500,000 c/mL

+3 more

Exclusion Criteria

My condition is advanced according to CDC or WHO guidelines, excluding certain conditions.

I am currently breastfeeding or plan to become pregnant or breastfeed during the study.

My liver function is severely impaired (Child-Pugh Class C).

+2 more

Participant Groups

The study tests the safety and effectiveness of a fixed-dose combination (FDC) of two drugs, Dolutegravir/Lamivudine (DTG/3TC), in treatment-naive HIV-1 infected adolescents. The trial includes a screening phase, up to 48 weeks of treatment, an optional extension up to 96 additional weeks, and possibly continued therapy thereafter.

1Treatment groups

Experimental Treatment

Group I: Participants receiving DTG + 3TC FDCExperimental Treatment1 Intervention

Eligible participants will receive FDC of DTG + 3TC 50/300 milligrams, tablets, given orally once daily.