← Back to Search

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
Awards & highlights

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
Select...
I am between 18 and 65 years old.
Select...
I have been on a stable HIV treatment for at least 48 weeks.
Select...
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:
Select...
My HIV condition is beyond stage 2 according to CDC guidelines.
Select...
I have active TB that's not fully treated or untreated latent TB.
Select...
I have not received any vaccines in the last 4 weeks.
Select...
I have not received blood products or immunoglobulin in the last 16 weeks.
Select...
I have not taken high doses of steroids recently.
Select...
My cancer is related to HIV, including types like Kaposi's sarcoma or lymphoma.
Select...
I have had HIV-related brain issues or a rare brain infection.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with adverse events (AEs)
Number of participants with local injection site reactions
Number of participants with systemic reactogenicity events
Secondary outcome measures
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).

Find a Location

Who is running the clinical trial?

Hookipa Biotech GmbHLead Sponsor
7 Previous Clinical Trials
860 Total Patients Enrolled
Head of Clinical DevelopmentStudy DirectorHookipa Biotech GmbH
4 Previous Clinical Trials
762 Total Patients Enrolled
~20 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top