What is the mechanism of action of this treatment?

Common treatments for HIV include antiretroviral therapy (ART), which typically involves a combination of drugs that inhibit various stages of the HIV life cycle, such as reverse transcriptase inhibitors, protease inhibitors, and integrase strand transfer inhibitors (InSTIs). These treatments work by preventing the virus from replicating, thereby reducing viral load and improving immune function. Investigational treatments like INO-6160, which use synthetic DNAs encoding HIV Env Trimer and Interleukin-12, aim to elicit specific immune responses by generating HIV-1 envelope protein-specific antibodies and T-cell responses. This approach is significant for HIV patients as it could potentially enhance the body's natural ability to fight the virus, offering a complementary strategy to traditional ART.

What side effects are associated with this type of intervention?

Common treatments for HIV, including antiretroviral therapy (ART) and investigational approaches like synthetic DNAs encoding HIV Env Trimer and Interleukin-12, can have various side effects. ART often causes gastrointestinal issues, fatigue, and metabolic changes such as lipodystrophy. Specific to immune-modulating treatments like INO-6160, potential side effects may include injection site reactions, flu-like symptoms, and immune-related adverse events. It is essential to monitor these side effects closely and discuss them with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved various antiretroviral therapies (ART) for the treatment of HIV, including integrase strand transfer inhibitors (InSTIs) and nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs). These treatments aim to suppress the viral load and improve immune function. Investigational drugs, such as those disrupting the CC chemokine receptor 5 (CCR5), have also been explored. While the INO-6160 trial focuses on synthetic DNAs encoding HIV Env Trimer and Interleukin-12 to elicit immune responses, current FDA-approved treatments primarily involve ART regimens that target different stages of the HIV life cycle.

What other types of research exist?

Promising alternatives to INO-6160 for HIV treatment in 2024 include: 1) mRNA-based vaccines targeting HIV envelope proteins, which have shown potential in eliciting strong immune responses. 2) Broadly neutralizing antibodies (bNAbs) that target multiple HIV strains and can be used in combination with other therapies. 3) Long-acting injectable antiretrovirals, such as cabotegravir and rilpivirine, which offer sustained viral suppression with less frequent dosing. 4) Gene editing technologies like CRISPR/Cas9, which are being explored to target and eliminate HIV reservoirs in the body.

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Virus Therapy

Synthetic DNA + Adjuvanted HIV Env Trimer Vaccine for HIV

Phase 1

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months following any receipt of study product

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new vaccine made from synthetic DNA and immune-boosting substances in people at risk of HIV infection. The vaccine aims to stimulate the immune system to produce antibodies and T-cells that can recognize and fight HIV. DNA vaccination has shown promise in enhancing immune responses.

Who is the study for?

Adults aged 18-55, at low risk for HIV, in good health with normal blood counts and organ function. Must not be pregnant or planning pregnancy, agree to use birth control, and avoid high-risk HIV behaviors. Excludes those with certain allergies, bleeding disorders, severe asthma, recent non-HIV vaccines or immunotherapies.

What is being tested?

The trial tests INO-6160 (synthetic DNAs for an HIV protein & immune booster) alone or followed by VRC HIV Env Trimer 4571 with adjuvants. It aims to see if these can elicit antibody and T-cell responses against HIV in a randomized open-label setup.

What are the potential side effects?

Potential side effects may include typical vaccine reactions like soreness at the injection site, mild fever or fatigue. Since it's testing new compounds there might also be unexpected immune reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months following any receipt of study product

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months following any receipt of study product

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months following any receipt of study product 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 and description of AEs leading to early participant withdrawal or permanent discontinuation and reason for withdrawal/discontinuation

Number and description of adverse events of special interest (AESIs)

Number and description of medically attended adverse events (MAAEs)

+3 more

Secondary study objectives

Epitope specificity of HIV-1 specific IgG binding Ab responses

Magnitude of CD4 +T-cell responses

Magnitude of CD8+T-cell responses

+8 more

Awards & Highlights

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: Group #2: INO-6160/ 2.0 mg with Trimer-4571 / 100 mcg 3M-052-AF (5 mcg) + Alum (500 mcg)Experimental Treatment2 Interventions

The dose of INO-6160, 2 mg, will be administered as 2 separate intradermal (ID) injections, one in each arm. The dose of Trimer 4571, 100 mcg, will be administered as 2 injections delivered intramuscularly (IM), one in each arm.

Group II: Group #1: INO-6160/ 2.0 mgExperimental Treatment1 Intervention

The dose of INO-6160, 2 mg, will be administered as 2 separate intradermal (ID) injections, one in each arm

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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

Common treatments for HIV include antiretroviral therapy (ART), which typically involves a combination of drugs that inhibit various stages of the HIV life cycle, such as reverse transcriptase inhibitors, protease inhibitors, and integrase strand transfer inhibitors (InSTIs). These treatments work by preventing the virus from replicating, thereby reducing viral load and improving immune function. Investigational treatments like INO-6160, which use synthetic DNAs encoding HIV Env Trimer and Interleukin-12, aim to elicit specific immune responses by generating HIV-1 envelope protein-specific antibodies and T-cell responses. This approach is significant for HIV patients as it could potentially enhance the body's natural ability to fight the virus, offering a complementary strategy to traditional ART.

Host transcriptomic signature as alternative test-of-cure in visceral leishmaniasis patients co-infected with HIV.ABCB1 variation and treatment response in AIDS patients: initial results of the Henan cohort.Advances in antiretroviral therapy.