What side effects are associated with this type of intervention?

Common treatments for HIV, such as the combination of Dolutegravir (DTG) and Lamivudine (3TC), are generally well-tolerated but can have side effects. Dolutegravir may cause insomnia, headache, and gastrointestinal issues like diarrhea and nausea. It has also been associated with weight gain and, rarely, hypersensitivity reactions. Lamivudine is usually well-tolerated but can cause headaches, fatigue, and gastrointestinal disturbances such as nausea and diarrhea. Both drugs can potentially lead to liver enzyme elevations, and monitoring is recommended during treatment.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of HIV infection that are similar to Dolutegravir and Lamivudine. Dolutegravir, an integrase inhibitor, is part of the class of drugs that includes other FDA-approved integrase inhibitors like Raltegravir and Elvitegravir. Lamivudine, a reverse transcriptase inhibitor, belongs to a class that includes other approved drugs such as Zidovudine, Abacavir, and Tenofovir. These drugs work by inhibiting key enzymes necessary for the replication of the HIV virus, thereby reducing viral load and improving immune function in patients.

What other types of research exist?

Promising novel alternatives to DTG/3TC for HIV treatment in 2024 include bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), which is a single-tablet regimen with high efficacy and a favorable safety profile. Another alternative is cabotegravir/rilpivirine (CAB/RPV) long-acting injectable, which offers the convenience of less frequent dosing (monthly or every two months) and has shown good efficacy in clinical trials. These options provide effective viral suppression with different mechanisms of action and dosing schedules, catering to patient preferences and needs.

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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

Must not have

Females who are breastfeeding or plan to become pregnant or breastfeed during the study

Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification

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

No Placebo-Only Group

Pivotal Trial

Summary

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.

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.

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.

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

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

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I weigh at least 25 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I do not have unstable liver disease, cirrhosis, or hepatitis B.

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for HIV, such as integrase inhibitors and reverse transcriptase inhibitors, work by targeting key enzymes necessary for viral replication. Integrase inhibitors like Dolutegravir (DTG) prevent the integration of viral DNA into the host genome, while reverse transcriptase inhibitors like Lamivudine (3TC) block the conversion of viral RNA into DNA. These mechanisms are crucial for reducing viral load and preventing disease progression, thereby improving the health and longevity of HIV patients.

Dolutegravir plus lamivudine dual therapy - a new option for initial antiretroviral therapy.Dolutegravir: a review of its use in the management of HIV-1 infection in adolescents and adults.