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Tests treatment safety and results for HIV -1 Infection
Official title A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIV
ClinicalTrials.gov ID: NCT07392372
What this study is testing
What is BNT351?
BNT351 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hiv -1 infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will test the safety and blood levels of the antibody BNT351 in people living without and with human immunodeficiency virus (HIV). This study will also test the anti-viral activity of BNT351 in people living with HIV (PLWH) with detectable virus levels.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Key Part A:
- Are HIV-1 and HIV-2 negative at Visit 0.
- Starting at Visit 0 and continuously until the last planned visit in this study are individuals who:
- Are assessed by the investigator as having a low likelihood of acquiring HIV and are committed to avoiding behaviors associated with a higher...
- Agree to discuss HIV disease risks;
You likely can't join if
- Parts A and B:
- Have received an HIV vaccination or HIV broadly neutralizing antibody in another clinical study.
- Have a known or suspected impairment/alteration of immune function or immunodeficiency (except for HIV infection, applicable to Part B only)...
- Have a history of generalized urticaria or angioedema, or of allergy, anaphylaxis, hypersensitivity or intolerance to a human or humanized antibody...
- Are receiving ongoing therapy for Mycobacterium tuberculosis infection.
- Have a history of opportunistic infections/AIDS-defining illnesses as defined in the protocol.
See the full eligibility criteria
- Key Part A:
- Are HIV-1 and HIV-2 negative at Visit 0.
- Starting at Visit 0 and continuously until the last planned visit in this study are individuals who:
- Are assessed by the investigator as having a low likelihood of acquiring HIV and are committed to avoiding behaviors associated with a higher likelihood of acquiring HIV until the End of Study Visit.
- Agree to discuss HIV disease risks;
- Agree to HIV acquisition risk reduction counseling; Part B:
- Are HIV-1 positive and HIV-2 negative at Visit 0.
- Individuals who at Visit 0:
- Are cART-naïve individuals who were diagnosed with HIV-1 infection ≤12 months prior to screening, OR are individuals who have discontinued cART and who were diagnosed with HIV-1 infection ≤12 months prior to screening...
- If cART-experienced, have discontinued cART for at least 4 weeks before screening (if the individual was taking long-acting antiretroviral therapy [ART]), see the following bullet). For individuals who have discontinued...
- Have never received lenacapavir or ibalizumab or fostemsavir, and have not received other long-acting ARTs in the last 6 months (i.e., intramuscular cabotegravir, cabotegravir-rilpivirine).
- Have a CD4+ T cell count of ≥500 cells/µL and plasma HIV-1 RNA levels between 5,000-100,000 copies/mL at screening.
- Are willing to initiate cART at a protocol-defined timepoint (56 days post-dose, or earlier if meeting early cART start criteria or at investigator's discretion).
- Are willing to undergo HIV transmission risk reduction counseling and to maintain low-risk behavior to protect their partners. Key
- Parts A and B:
- Have received an HIV vaccination or HIV broadly neutralizing antibody in another clinical study.
- Have a known or suspected impairment/alteration of immune function or immunodeficiency (except for HIV infection, applicable to Part B only), including receipt of any immunostimulant, immunomodulator, immunosuppressive...
- Have a history of generalized urticaria or angioedema, or of allergy, anaphylaxis, hypersensitivity or intolerance to a human or humanized antibody or to BNT351 excipients. Part B only:
- Are receiving ongoing therapy for Mycobacterium tuberculosis infection.
- Have a history of opportunistic infections/AIDS-defining illnesses as defined in the protocol.
- Have a history of multi-class drug resistant HIV-1 infection defined as resistance to three or more classes of HIV drugs.
- Have a history of malignancy within 5 years before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered in the investigator's...
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Cologne, Germany
- Mannheim, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Baltimore, Maryland, United States; St Louis, Missouri, United States; New York, New York, United States; Cologne, Germany; Mannheim, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.