What side effects are associated with this type of intervention?

Common treatments for HIV, particularly those involving Integrase Strand Transfer Inhibitors (INSTIs) like Dolutegravir, often include side effects such as insomnia, headache, and gastrointestinal issues like diarrhea and nausea. Other potential side effects can include weight gain and, in rare cases, hypersensitivity reactions. It's important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Dolutegravir, an integrase strand transfer inhibitor (INSTI), has been approved by the FDA for the treatment of HIV infection. It is often used in combination therapies such as abacavir/dolutegravir/lamivudine (ABC/DTG/3TC), marketed as Triumeq. Other FDA-approved INSTIs include Raltegravir (Isentress) and Elvitegravir, which is part of the combination therapy Stribild (Elvitegravir/cobicistat/emtricitabine/tenofovir). These drugs work by inhibiting the integrase enzyme, preventing the integration of viral DNA into the host genome, which is a critical step in the HIV replication cycle.

What other types of research exist?

Promising novel alternatives to Dolutegravir for HIV treatment in 2024 include Bictegravir, a potent INSTI that is part of the fixed-dose combination Biktarvy (Bictegravir/Emtricitabine/Tenofovir alafenamide), and Cabotegravir, another INSTI that is available as a long-acting injectable formulation in combination with Rilpivirine (Cabenuva). Additionally, Lenacapavir, a first-in-class capsid inhibitor, is showing promise in clinical trials for its long-acting potential and efficacy in heavily treatment-experienced patients.

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Dolutegravir for HIV

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

Parent or legal guardian or participant >=18 years of age is able and willing to provide signed informed consent.

Be younger than 65 years old

Must not have

Confirmed virologic failure with evidence of resistance to: DTG in the P1093 parent study, or ABC, DTG or 3TC (with the exception of M184V) in the P2019 parent study.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial aims to provide continued access to a combination of HIV medications for children who participated in earlier studies and cannot get these treatments locally. The medications work together to stop the virus from multiplying and help manage HIV infection. The study will ensure these children can keep receiving their treatment until it becomes available through other sources. Ritonavir has been used in combination therapies for children with advanced HIV infection, showing benefits in improving their health.

Who is the study for?

This trial is for children and adolescents who have HIV-1 and were part of previous studies P1093 or P2019. They must show benefits from the prior treatments without significant side effects or virologic failure. Participants need to practice safe sex, and females of childbearing age must use birth control.

What is being tested?

The study tests ongoing effectiveness of Dolutegravir-based treatments (ABC/DTG/3TC) in tablet forms for pediatric patients with HIV-1. It's an open-label, phase 3b trial providing continued access to these drugs until they're publicly available.

What are the potential side effects?

Possible side effects include allergic reactions, blood disorders like low neutrophil count or hemoglobin, liver issues indicated by elevated enzymes, pancreatitis symptoms, and potential drug interactions leading to increased toxicity.

Eligibility Criteria

Inclusion Criteria

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

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I, or my guardian if I'm under 18, can and will sign the consent form.

Exclusion Criteria

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

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My HIV treatment with DTG, ABC, or 3TC failed due to drug resistance.

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I am not pregnant, planning to become pregnant, or breastfeeding during the study.

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I am not taking any medications that are not allowed in this study.

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I am HLA-B*5701 positive and was in the P2019 study taking ABC/DTG/3TC.

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I do not have any active infections related to AIDS.

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I have been diagnosed with pancreatitis by my doctor.

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I might need treatment for Hepatitis C that could interfere with the study's treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of participants with continued access to age appropriate formulation of dolutegravir

Secondary study objectives

Number of participants with SAEs based on the severity

Number of participants with any clinical or laboratory adverse events leading to discontinuation of investigational product

Number of participants with serious adverse events (SAEs) as a measure of safety

Awards & Highlights

Pivotal Trial

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

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dolutegravir (Tivicay)Experimental Treatment2 Interventions

All participants will receive dolutegravir film-coated tablets or film-coated dispersible tablets at appropriate doses selected as per their age and weight bands. For those participants who were previously receiving dolutegravir in study P1093 (parent study), dolutegravir will be supplied as film-coated tablets containing 50 mg; and 5 mg film-coated dispersible tablets of dolutegravir. Participants will receive dolutegravir until age-appropriate formulations are available to them from some other source, or until participant is no longer deriving benefit from treatment, or participant is discontinued, or until development of dolutegravir is terminated.

Group II: ABC/DTG/3TCExperimental Treatment2 Interventions

All participants will receive ABC/DTG/3TC immediate release tablets or film-coated dispersible tablets at appropriate doses selected as per their weight bands. For those participants who were previously receiving ABC/DTG/3TC in study P2019 (parent study), ABC/DTG/3TC will be supplied as immediate release tablets containing 600 mg, 50 mg and 300 mg of ABC, DTG, and 3TC respectively and film-coated dispersible tablets containing 60 mg, 5 mg and 30 mg of ABC, DTG, and 3TC respectively. Participants will receive ABC/DTG/3TC until age-appropriate formulations are available to them from some other source, until participant is no longer deriving benefit from treatment, or until participant is discontinued, or until development of ABC/DTG/3TC is terminated.

0 / 8Eligibility 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

The most common treatments for HIV infection include antiretroviral drugs such as Integrase Strand Transfer Inhibitors (INSTIs), Nucleoside Reverse Transcriptase Inhibitors (NRTIs), and Protease Inhibitors (PIs). Dolutegravir, an INSTI, works by blocking the HIV integrase enzyme, which is essential for the viral DNA to integrate into the host cell's genome, thereby preventing viral replication. NRTIs, like abacavir and lamivudine, inhibit the reverse transcriptase enzyme, which is crucial for converting viral RNA into DNA. Protease Inhibitors prevent the protease enzyme from cleaving viral proteins into functional units, thus hindering the assembly of new viral particles. These treatments are vital for HIV patients as they reduce viral load, improve immune function, and decrease the risk of HIV-related complications and transmission.