Phase 1 HIV and AIDS Trial, Recruiting (NCT07392372)

Phase 1 HIV and AIDS Trial, Recruiting NCT07392372 Sponsor: BioNTech SE Condition: HIV and AIDS

Printed from Voxsanity (voxsanity.com.au) — NCT07392372 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

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Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

Group A (people without HIV):

You have tested negative for both HIV-1 and HIV-2 at the start of the study
Your doctor considers you to have a low chance of getting HIV, and you are committed to avoiding higher-risk behaviors throughout the study
You agree to talk openly about HIV risk and receive counseling on how to reduce your risk of getting HIV

Group B (people living with HIV):

You have tested positive for HIV-1 but negative for HIV-2 at the start of the study
You were diagnosed with HIV-1 no more than 12 months ago (or up to 18 months ago in some cases — confirm with trial site), and you are either new to HIV treatment or have stopped treatment recently
If you have previously taken HIV treatment, you stopped it at least 4 weeks before the screening appointment
You have never taken the specific HIV medicines lenacapavir, ibalizumab, or fostemsavir, and have not had certain long-acting injectable HIV treatments in the past 6 months
Your immune cell count (CD4+) is at or above 500, and your HIV virus levels fall within a specific range at screening (confirm with trial site for exact numbers)
You are willing to start HIV treatment at a set point during the study (around 56 days after your dose, or earlier if needed)
You are willing to receive counseling and take steps to protect your partners from HIV

Who may not be able to join:

For both groups:

You have previously received an HIV vaccine or a type of HIV antibody treatment in another clinical study
You have a known problem with your immune system (other than HIV, for Group B), or you have taken certain medications that affect the immune system — such as steroids, immunosuppressants, or blood products — within the past 60 days or plan to during the study (note: some inhaled, topical, or locally applied steroids are allowed — confirm with trial site)
You have a history of serious allergic reactions, hives, severe swelling (angioedema), or known allergy to similar antibody-based medicines or to the ingredients in the study drug

For Group B only:

You are currently being treated for tuberculosis (TB)
You have a history of serious infections or illnesses that are linked to advanced HIV/AIDS
Your HIV has shown resistance to three or more types (classes) of HIV medications
You have had cancer in the past 5 years (some minor skin cancers or very low-risk cases may be exceptions — confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 7 July 2026

Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: BioNTech Response Person, BioNTech SE

Phone: +49 6131 9084

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT07392372

Sponsor: BioNTech SE

Phase: Phase 1

Status: Recruiting

Condition: HIV and AIDS

Trial contact: +49 6131 9084

More information: https://clinicaltrials.gov/study/NCT07392372

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Group A (people without HIV):

You have tested negative for both HIV-1 and HIV-2 at the start of the study
Your doctor considers you to have a low chance of getting HIV, and you are committed to avoiding higher-risk behaviors throughout the study
You agree to talk openly about HIV risk and receive counseling on how to reduce your risk of getting HIV

Group B (people living with HIV):

You have tested positive for HIV-1 but negative for HIV-2 at the start of the study
You were diagnosed with HIV-1 no more than 12 months ago (or up to 18 months ago in some cases — confirm with trial site), and you are either new to HIV treatment or have stopped treatment recently
If you have previously taken HIV treatment, you stopped it at least 4 weeks before the screening appointment
You have never taken the specific HIV medicines lenacapavir, ibalizumab, or fostemsavir, and have not had certain long-acting injectable HIV treatments in the past 6 months
Your immune cell count (CD4+) is at or above 500, and your HIV virus levels fall within a specific range at screening (confirm with trial site for exact numbers)
You are willing to start HIV treatment at a set point during the study (around 56 days after your dose, or earlier if needed)
You are willing to receive counseling and take steps to protect your partners from HIV

Who may not be able to join:

For both groups:

You have previously received an HIV vaccine or a type of HIV antibody treatment in another clinical study
You have a known problem with your immune system (other than HIV, for Group B), or you have taken certain medications that affect the immune system — such as steroids, immunosuppressants, or blood products — within the past 60 days or plan to during the study (note: some inhaled, topical, or locally applied steroids are allowed — confirm with trial site)
You have a history of serious allergic reactions, hives, severe swelling (angioedema), or known allergy to similar antibody-based medicines or to the ingredients in the study drug

For Group B only:

You are currently being treated for tuberculosis (TB)
You have a history of serious infections or illnesses that are linked to advanced HIV/AIDS
Your HIV has shown resistance to three or more types (classes) of HIV medications
You have had cancer in the past 5 years (some minor skin cancers or very low-risk cases may be exceptions — confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 7 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Phase 1

Sponsor

BioNTech SE

Registry

ClinicalTrials.gov

Start date

9 February 2026

Est. completion

1 November 2026

Where this trial is recruiting

🇩🇪 Germany 🇺🇸 United States

Primary endpoints

Parts A and B - Occurrence of at least one adverse event (AE); Parts A and B - Occurrence of at least one serious AE (SAE); Parts A and B (except for Cohort A1) - Occurrence of infusion-related reactions (IRRs) Grade ≥2 (graded based on National Cancer Institute Common Terminology Criteria for AEs [NCI CTCAE] version 5.0 as specified in the protocol); Parts A and B - Occurrence of at least one solicited local reaction (pain/tenderness, erythema/redness, induration/swelling) at the investigational medicinal product administration site; Parts A and B- Occurrence of at least one solicited systemi...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 7 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov