Is NCT07392372 recruiting in Baltimore, MD?

Yes, NCT07392372 is currently recruiting participants at its Baltimore, MD location. This hiv -1 infection clinical trial is actively enrolling qualified participants.

How do I join the hiv -1 infection clinical trial in Baltimore?

To join this clinical trial in Baltimore, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Baltimore clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

HIV -1 Infection Clinical Trial in Baltimore, MD

About This HIV -1 Infection Study in Baltimore

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. The main goals of this study are: * To learn about the safety of BNT351 and check for side effects. * To measure the amount of BNT351 antibody in blood over time. * To test the amount of HIV in the blood at different times after treatment with BNT351 in people living with HIV.

Sponsor: BioNTech SE

Who Can Participate

Inclusion Criteria

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 or ≤18 months if this is found to be acceptable after discussion on a case-by-case basis with the sponsor's medical monitor.

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 cART: Are able to comply with study procedures and assessments in the investigator's judgment.

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

Exclusion Criteria

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 medication, immunoglobulin, blood product, or oral or parenteral steroid within 60 days prior to Day 1 or planned administration during the study. The following exception applies: Use of inhaled, intranasal, topical, or locally injected corticosteroids (e.g., intraarticular or intrabursal administration) is allowed.

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 judgment to have minimal risk of recurrence. Any malignancy that is an AIDS-defining illness (as defined in the protocol) is exclusionary regardless of the perceived risk of recurrence. NOTE: Other protocol defined inclusion/exclusion criteria apply.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Baltimore?

Yes, this clinical trial (NCT07392372) has an active research site in Baltimore, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

HIV -1 Infection Treatment Options in Baltimore, MD

If you're searching for hiv -1 infection treatment options in Baltimore, MD, this clinical trial (NCT07392372) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Baltimore research site is actively enrolling participants for this clinical trial. You'll receive care from experienced hiv -1 infection specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hiv -1 infection clinical trials near you to find additional studies recruiting in your area.

HIV -1 Infection Clinical Trial in Baltimore, MD

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