What side effects are associated with this type of intervention?

Common side effects of antiretroviral therapies similar to Dolutegravir/Lamivudine (DTG/3TC) and Cabotegravir plus Rilpivirine (CAB + RPV LA) include gastrointestinal issues such as nausea and diarrhea, headaches, and fatigue. Integrase inhibitors like Dolutegravir and Cabotegravir can sometimes cause insomnia and weight gain. Rilpivirine may lead to depression and sleep disturbances, while Lamivudine is generally well-tolerated but can cause mild gastrointestinal symptoms and, rarely, lactic acidosis. Long-acting injectable forms like CAB + RPV LA may also cause injection site reactions.

What prior FDA approvals exist?

The FDA has approved several antiretroviral therapies for the treatment of HIV, including those similar to Dolutegravir/Lamivudine (DTG/3TC) and Cabotegravir plus Rilpivirine (CAB + RPV LA). Dolutegravir (DTG) is an integrase strand transfer inhibitor (INSTI) often combined with Lamivudine (3TC), a nucleoside reverse transcriptase inhibitor (NRTI), for a once-daily oral regimen. Cabotegravir (CAB), another INSTI, combined with Rilpivirine (RPV), a non-nucleoside reverse transcriptase inhibitor (NNRTI), is available as a long-acting injectable regimen administered every two months. These treatments aim to achieve and maintain viral suppression in HIV-infected individuals.

What other types of research exist?

Promising novel alternatives to DTG/3TC and CAB + RPV LA for HIV treatment in 2024 include: 1. Lenacapavir: A long-acting capsid inhibitor with potential for biannual dosing. 2. Islatravir: A nucleoside reverse transcriptase translocation inhibitor (NRTTI) with a long half-life, allowing for less frequent dosing. 3. Fostemsavir: An attachment inhibitor that prevents HIV from binding to host cells, suitable for heavily treatment-experienced patients. 4. Doravirine-based regimens: Newer non-nucleoside reverse transcriptase inhibitors (NNRTIs) with a favorable safety profile and efficacy. These alternatives offer different mechanisms of action and dosing schedules, providing more options for personalized HIV treatment.

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Antiretroviral Therapy

Oral vs Injectable Therapy for HIV (VOLITION Trial)

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (week 4) and at month 6 and 12

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing two treatments for people with HIV-1 who haven't had previous treatments. Participants start with a pill to manage the virus and may later switch to an injection. The study aims to see how well these treatments work and how patients feel about them.

Who is the study for?

Adults with HIV-1 who haven't taken antiretroviral therapy before can join this trial. They must have a certain level of HIV in their blood and be able to consent to the study's requirements. People with severe liver issues, heart conditions, risk of suicide, untreated syphilis or hepatitis B infection, recent exposure to experimental drugs or vaccines, or those on certain medications are excluded.

What is being tested?

The trial is testing two drug regimens for treating HIV-1: an oral tablet (DTG/3TC) taken daily and long-acting injectable drugs (CAB + RPV LA) given every two months. Participants start with the oral tablet and after viral suppression can choose to switch to injections or continue pills.

What are the potential side effects?

Possible side effects include allergic reactions, liver problems, digestive disturbances, changes in body fat distribution and bone density loss for DTG/3TC; injection site reactions, fever-like symptoms and potential organ damage for CAB + RPV LA.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 4) and at month 6 and 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week 4) and at month 6 and 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 4) and at month 6 and 12 for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Change From Baseline in Anxiety and Depression Score Using General Anxiety Disorder 7 (GAD-7) Through Day of Choice

Change From Baseline in Anxiety and Depression Score Using Patient Health Questionnaire 9 (PHQ-9) Through Day of Choice

Change From Baseline in Health-Related Quality of Life Using World Health Organisation Quality of Life Brief version (WHOQoL-HIV-BREF) Through Day of Choice

+23 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

2Treatment groups

Experimental Treatment

Group I: Participants Receiving DTG/3TC Fixed Dose Combination (FDC)Experimental Treatment1 Intervention

Group II: Participants Receiving CAB + RPV LAExperimental Treatment2 Interventions

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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

Dolutegravir (DTG) is an integrase strand transfer inhibitor (INSTI) that prevents the integration of viral DNA into the host genome, a critical step in HIV replication. Lamivudine (3TC) is a nucleoside reverse transcriptase inhibitor (NRTI) that inhibits reverse transcriptase, an enzyme HIV uses to convert its RNA into DNA. Cabotegravir (CAB) is another INSTI similar to DTG, and Rilpivirine (RPV) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that also targets reverse transcriptase but through a different mechanism. These treatments are essential for HIV patients as they reduce viral load, improve immune function, and decrease the risk of HIV-related complications and transmission.

Dolutegravir plus lamivudine dual therapy - a new option for initial antiretroviral therapy.Dolutegravir, a second-generation integrase inhibitor for the treatment of HIV-1 infection.