What side effects are associated with this type of intervention?

Common treatments for HIV, such as antiretroviral therapy (ART), can cause side effects including gastrointestinal issues (nausea, diarrhea), metabolic changes (lipodystrophy, insulin resistance), and cardiovascular risks. Investigational vaccines like Trimer 4571, which aim to stimulate broadly neutralizing antibodies, may cause local injection site reactions (pain, erythema), mild systemic reactions (fever, fatigue), and rare hypersensitivity reactions.

What other types of research exist?

Promising novel alternatives to Trimer 4571 for HIV treatment include AMD11070, an orally bioavailable inhibitor of CXCR4-tropic HIV, which has shown antiviral activity in clinical trials. Additionally, advancements in broadly neutralizing antibodies (bnAbs) and CAR T-cell therapies targeting HIV are also being explored as potential treatments.

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Cancer Vaccine

HIV Vaccine for HIV Infection (NETI Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for HIV include antiretroviral therapy (ART) which typically involves a combination of drugs from different classes: nucleoside reverse transcriptase inhibitors (NRTIs) that block reverse transcriptase, preventing viral RNA from converting into DNA; non-nucleoside reverse transcriptase inhibitors (NNRTIs) that bind to and inhibit reverse transcriptase; protease inhibitors (PIs) that prevent viral replication by inhibiting the protease enzyme; integrase strand transfer inhibitors (INSTIs) that block the integrase enzyme, preventing viral DNA from integrating into the host genome; and entry inhibitors that block the virus from entering host cells. These treatments are crucial as they reduce viral load, improve immune function, and decrease the risk of HIV-related complications. The investigational vaccine Trimer 4571 aims to stimulate the development of broadly neutralizing antibodies (bnAbs) against HIV, which could provide a new avenue for immune system-based control of the virus, potentially offering a complementary approach to existing ART regimens.

Q: What prior FDA approvals exist?

The FDA has approved various antiretroviral therapies (ART) for the treatment of HIV infection, including nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase strand transfer inhibitors (INSTIs), and entry inhibitors. While Trimer 4571 is an investigational vaccine designed to stimulate the development of broadly neutralizing antibodies (bnAbs) against HIV, current FDA-approved treatments primarily focus on inhibiting viral replication rather than stimulating bnAbs. Examples of approved drugs include tenofovir, emtricitabine, efavirenz, and dolutegravir. The development of bnAbs as a treatment strategy is still under investigation and represents a novel approach compared to existing ART regimens.

Phase 1

Recruiting

Led By Madhu Choudhary, MD

Research Sponsored by Madhu Chhanda Choudhary

Eligibility Criteria Checklist

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

Must have

Receiving continuous antiretroviral therapy (ART) for at least 24 months with no interruptions longer than 30 consecutive days and no changes in the components of the ART for at least 8 weeks prior to study entry

Plasma HIV-1 RNA levels < 50 copies/ml for at least 24 months on ART prior to study entry with at least one documented HIV-1 RNA < 50 copies/ml within 12 months prior to study entry

Must not have

Serious medical illness that requires systemic treatment and/or hospitalization within 30 days prior to entry

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0 through week 44

Summary

This trial is testing a new vaccine called Trimer 4571 to see if it can help people with HIV by making their immune system produce special proteins that fight the virus. The study will involve about 32 participants over several months. Researchers aim to find out if the vaccine is safe and effective in boosting the body's defense against HIV.

Who is the study for?

Adults over 18 living with HIV on stable antiretroviral therapy (ART) for at least 24 months, with undetectable viral loads and no history of severe allergies or chronic inflammatory conditions. Participants must not be pregnant, breastfeeding, or have a BMI over 40kg/m2, and should agree to use contraception during the trial.

What is being tested?

The Trimer 4571 vaccine is being tested in two different doses combined with alum as an adjuvant against placebo controls. The study aims to see if it's safe for people with HIV and whether it can stimulate the immune system to produce antibodies against HIV.

What are the potential side effects?

As Trimer 4571 is investigational and new to humans with HIV, potential side effects are not fully known but may include typical vaccine reactions like soreness at injection site, fever, fatigue or allergic responses.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been on consistent HIV medication for at least 2 years without a break longer than 30 days.

Select...

My HIV-1 levels have been under control for at least 2 years with treatment.

Exclusion Criteria

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

Select...

I haven't been hospitalized or needed serious treatment in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0 through week 44

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0 through week 44

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 through week 44 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Safety and tolerability of three vaccinations of Trimer 4571 vaccine in adults with HIV on suppressive ART

Secondary study objectives

HIV

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Randomized Blinded Trimer 4571 Vaccine 500mcgExperimental Treatment1 Intervention

Eighteen (18) participants will receive Trimer 4571 vaccine 500mcg with 500mcg alum adjuvant as a 1.1ml intramuscular injection at Day 0, Week 8 and Week 20.

Group II: Randomized Blinded Trimer 4571 Vaccine 100mcgExperimental Treatment1 Intervention

Six (6) participants will receive Trimer 4571 vaccine 100mcg with 500mcg alum adjuvant as a 1ml intramuscular injection at Day 0, Week 8 and Week 20.

Group III: Randomized Blinded Placebo for Trimer 4571 Vaccine 100mcgPlacebo Group1 Intervention

Two (2) participants will receive the placebo control for Trimer 4571 vaccine 100mcg as a 1ml intramuscular injection at Day 0, Week 8 and Week 20.

Group IV: Randomized Blinded Placebo for Trimer 4571 Vaccine 500mcgPlacebo Group1 Intervention

Six (6) participants will receive the placebo control for Trimer 4571 vaccine 500mcg as a 1.1ml intramuscular injection at Day 0, Week 8 and Week 20.

0 / 3Eligibility 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 include antiretroviral therapy (ART) which typically involves a combination of drugs from different classes: nucleoside reverse transcriptase inhibitors (NRTIs) that block reverse transcriptase, preventing viral RNA from converting into DNA; non-nucleoside reverse transcriptase inhibitors (NNRTIs) that bind to and inhibit reverse transcriptase; protease inhibitors (PIs) that prevent viral replication by inhibiting the protease enzyme; integrase strand transfer inhibitors (INSTIs) that block the integrase enzyme, preventing viral DNA from integrating into the host genome; and entry inhibitors that block the virus from entering host cells. These treatments are crucial as they reduce viral load, improve immune function, and decrease the risk of HIV-related complications. The investigational vaccine Trimer 4571 aims to stimulate the development of broadly neutralizing antibodies (bnAbs) against HIV, which could provide a new avenue for immune system-based control of the virus, potentially offering a complementary approach to existing ART regimens.