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Virus Therapy

HB-502 + HB-501 for HIV

Phase 1

Recruiting

Research Sponsored by Hookipa Biotech GmbH

Eligibility Criteria Checklist

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

Must have

Participants 18 to 65 years of age

Must be on stable suppressive antiretroviral treatment (ART) for at least 48 weeks prior to screening

Must not have

More than stage 2 HIV-related illness based on the Revised Surveillance Case Definition for HIV Infection (CDC 2014)

Current untreated or incompletely treated active TB disease or untreated latent TB infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dosing until 48 weeks after first dosing

Summary

This trial is testing a new treatment for people with HIV who are already taking antiretroviral medication. The new treatment, HB-502 and HB-501, aims to help the body recognize

Who is the study for?

This trial is for people living with HIV who are currently on suppressive antiretroviral therapy (ART). Participants should be stable on ART, have a suppressed viral load, and meet other health criteria to ensure safety during the trial.

What is being tested?

The study tests HB-502 and HB-501 therapies designed to boost the immune response against HIV. It compares two different dose levels of these therapies against a placebo. Participants will receive injections every 8 weeks over six months.

What are the potential side effects?

Potential side effects may include reactions at the injection site, flu-like symptoms, fatigue, headache, or fever as the body's immune system responds to the treatment.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 65 years old.

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I have been on a stable HIV treatment for at least 48 weeks.

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My CD4+ cell count is above 450 and the percentage is at least 15%.

Exclusion Criteria

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

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My HIV condition is beyond stage 2 according to CDC guidelines.

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I have active TB that's not fully treated or untreated latent TB.

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I have not received any vaccines in the last 4 weeks.

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I have not received blood products or immunoglobulin in the last 16 weeks.

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I have not taken high doses of steroids recently.

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My cancer is related to HIV, including types like Kaposi's sarcoma or lymphoma.

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I have had HIV-related brain issues or a rare brain infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dosing until 48 weeks after first dosing

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dosing until 48 weeks after first dosing

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dosing until 48 weeks after first dosing 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 adverse events (AEs)

Number of participants with local injection site reactions

Number of participants with systemic reactogenicity events

Secondary study objectives

Determine the breadth of the cellular immune response against HIV-1 induced by HB-502 and HB-501 alternating 2-vector therapy compared with placebo

Determine the magnitude of the cellular immune response against HIV-1 induced by HB-502 and HB-501 alternating 2-vector therapy compared with placebo

Trial Design

2Treatment groups

Experimental Treatment

Group I: HB-502 and HB-501 alternating 2-vector therapy (Dose Level 2) OR placeboExperimental Treatment2 Interventions

Intramuscular injection of HB-502 and HB-501 alternating 2-vector therapy at Dose Level 2 OR placebo every 8 weeks for 24 weeks (injections at Weeks 0, 8, 16, and 24).

Group II: HB-502 and HB-501 alternating 2-vector therapy (Dose Level 1) OR placeboExperimental Treatment2 Interventions

Intramuscular injection of HB-502 and HB-501 alternating 2-vector therapy at Dose Level 1 OR placebo every 8 weeks for 24 weeks (injections at Weeks 0, 8, 16, and 24).

0 / 10Eligibility criteria met