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Antiretroviral

DTG/3TC for HIV-1 in Adolescents

Phase 3

Waitlist Available

Research Sponsored by ViiV Healthcare

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

HIV-1 infected adolescents aged >=12 to <18 years at the time of signing the informed consent form

Weight >=25 kg at the time of signing the informed consent form

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-dose, 0.5, 1.0, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose at week 1

Awards & highlights

Study Summary

This trial is studying the effects of a new two-drug regimen for HIV-infected adolescents who have not taken any HIV medications before.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

DTG/3TC regimen is generally well-tolerated but may include common side effects like headaches, digestive issues such as nausea or diarrhea, fatigue, potential allergic reactions and rarely more serious effects related to liver health or changes in blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an adolescent with HIV, aged 12 to under 18, and can sign the consent form.

Select...

I weigh at least 25 kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose, 0.5, 1.0, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose at week 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose, 0.5, 1.0, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose at week 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, 0.5, 1.0, 1.5, 2, 3, 4, 6, 10, and 24 hours post-dose at week 1 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Less Than 50 Copies Per Milliliter (c/mL) at Week 48

Secondary outcome measures

Apparent Terminal Half-life (t1/2) Following Dosing With DTG and 3TC

Area Under the Curve (AUC) Over the Dosing Interval (AUC[0-tau]) Following Dosing With DTG and 3TC

Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC[0-t]) Following Dosing With DTG and 3TC

+41 more

Trial Design

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

ViiV HealthcareLead Sponsor

359 Previous Clinical Trials

468,511 Total Patients Enrolled

GSK Clinical TrialsStudy DirectorViiV Healthcare

3,595 Previous Clinical Trials

6,143,898 Total Patients Enrolled

Media Library

DTG + 3TC FDC (Antiretroviral) Clinical Trial Eligibility Overview. Trial Name: NCT03682848 — Phase 3

Human Immunodeficiency Virus Infection Research Study Groups: Participants receiving DTG + 3TC FDC

Human Immunodeficiency Virus Infection Clinical Trial 2023: DTG + 3TC FDC Highlights & Side Effects. Trial Name: NCT03682848 — Phase 3

DTG + 3TC FDC (Antiretroviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03682848 — Phase 3

Frequently Asked Questions

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

Could you tell me if this trial is only available to people over the age of 55?

"According to the inclusion criteria set forth by the researchers, the minimum age requirement for participants is 12 and the maximum is 17."

Answered by AI

Which patient population is eligible for this clinical trial?

"This study is looking for 32 participants between the ages of 12 and 17 who currently have HIV infections. It is important that participants also meet the following criteria: Antiretroviral-naive (defined as no prior therapy with any antiretroviral agent for the treatment of HIV following a diagnosis of HIV-1 infection). Participants who received ART for prevention of mother to child transmission of HIV in the first 3 months of life are allowed. Participants who received HIV post-exposure prophylaxis (PEP) or pre-exposure prophylaxis (Prep) in the past are allowed as long"

Answered by AI