What is the mechanism of action of this treatment?

HIV treatments commonly include NNRTIs and NRTTIs, which target the reverse transcriptase enzyme crucial for HIV replication. NNRTIs, like Doravirine, bind to and inhibit the reverse transcriptase enzyme, preventing the conversion of viral RNA into DNA, thus halting viral replication. NRTTIs, such as Islatravir, incorporate into the viral DNA and cause premature chain termination, further preventing the virus from replicating. These mechanisms are vital for HIV patients as they help maintain viral suppression, reduce the risk of resistance, and improve overall health outcomes.

What side effects are associated with this type of intervention?

Common side effects of HIV treatments, particularly those involving Doravirine (NNRTI) and Islatravir (NRTTI), include headache, fatigue, nausea, and diarrhea. Doravirine has been associated with fewer neuropsychiatric side effects compared to other NNRTIs. Serious adverse events are rare but can include severe skin reactions and liver toxicity. As with most antiretroviral therapies, monitoring for potential drug interactions and side effects is essential to ensure patient safety and treatment efficacy.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of HIV, particularly in the classes of NNRTIs and NRTTIs. Doravirine, an NNRTI, was approved for use in combination with other antiretroviral agents to treat HIV-1 infection. Other notable NNRTIs include efavirenz and rilpivirine. In the NRTTI class, although Islatravir is still under investigation, other NRTIs like tenofovir and emtricitabine have been widely used and approved for HIV treatment. These drugs work by inhibiting the reverse transcriptase enzyme, crucial for viral replication, thereby helping to manage and suppress HIV infection.

What other types of research exist?

Promising novel alternatives to DOR/ISL for HIV treatment in 2024 include long-acting injectable therapies such as Cabotegravir combined with Rilpivirine, which have shown efficacy in maintaining viral suppression with less frequent dosing. Additionally, Lenacapavir, a capsid inhibitor, is being explored for its potential in both treatment and prevention of HIV. These alternatives offer new mechanisms of action and dosing strategies that may improve adherence and outcomes for patients.

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Antiretroviral

DOR/ISL Switch for HIV

Phase 3

Waitlist Available

Research Sponsored by Merck Sharp & Dohme LLC

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 at day 1 and week 144

Awards & highlights

Pivotal Trial

Summary

This trial is testing if switching to a new HIV treatment is as good or better than continuing the current treatment. The study focuses on people with HIV-1 who are already on a specific treatment. The new treatment works by reducing the amount of HIV in the blood, helping to keep the immune system healthy.

Who is the study for?

This trial is for adults with HIV-1 who are virologically suppressed on BIC/FTC/TAF therapy. Participants must have maintained viral suppression for at least 3 months and cannot be pregnant, breastfeeding, or planning to become pregnant. They should not have a history of treatment failure or resistance to DOR, active hepatitis B or C infections, certain cancers within the last 5 years, or be using strong immune system affecting drugs.

What is being tested?

The study compares switching HIV-1 positive patients from their current medication (BIC/FTC/TAF) to a new combination drug (DOR/ISL) versus continuing their current regimen. The goal is to see if DOR/ISL maintains virus suppression as effectively as BIC/FTC/TAF after 48 weeks without causing significant side effects.

What are the potential side effects?

Potential side effects include those commonly associated with antiretroviral therapy such as nausea, headache, fatigue, and diarrhea. Specific side effects related to DOR/ISL may also occur but are being studied for comparison against the established treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline at day 1 and week 144

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline at day 1 and week 144

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline at day 1 and week 144 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 who discontinue study intervention due to AEs through Week 48

Percentage of participants who experience adverse events (AEs) through Week 48

Percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48

Secondary study objectives

Change from baseline in CD4+ T-cell count at Week 144

Change from baseline in CD4+ T-cell count at Week 48

Change from baseline in CD4+ T-cell count at Week 96

+13 more

Awards & Highlights

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: DOR/ISL and Placebo to BIC/FTC/TAFExperimental Treatment2 Interventions

Participants will receive DOR/ISL 100 mg/0.25 mg and Placebo to BIC/FTC/TAF once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may continue on DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).

Group II: BIC/FTC/TAF and Placebo to DOR/ISLActive Control2 Interventions

Participants will receive BIC/FTC/TAF 50 mg/200 mg/25 mg and Placebo to DOR/ISL once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may switch to DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

DOR/ISL

2020

Completed Phase 3

~750

Do I qualify?Apply below to find out

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

HIV treatments commonly include NNRTIs and NRTTIs, which target the reverse transcriptase enzyme crucial for HIV replication. NNRTIs, like Doravirine, bind to and inhibit the reverse transcriptase enzyme, preventing the conversion of viral RNA into DNA, thus halting viral replication. NRTTIs, such as Islatravir, incorporate into the viral DNA and cause premature chain termination, further preventing the virus from replicating. These mechanisms are vital for HIV patients as they help maintain viral suppression, reduce the risk of resistance, and improve overall health outcomes.

New Antiretroviral Treatment for HIV.Advances in antiretroviral therapy.Antiretroviral regimens sparing agents from the nucleoside(tide) reverse transcriptase inhibitor class: a review of the recent literature.