A Trial to Evaluate the Safety and Tolerability of DV700P-RNA and DV701B1.1-RNA Immunization in Combination With Antiretroviral Analytical Treatment Interruption (ATI) in People Living With HIV for Elicitation of V3-glycan Antibodies

Ki vehet részt

• Able and willing to provide informed consent
• Age 18 to 60 years
• Documented HIV infection
• Lowest (nadir) CD4+ count between 250 and 450 cells/mm³
• On stable combination antiretroviral therapy (ART) for at least 48 weeks prior to screening
• Plasma HIV RNA <50 copies/mL for at least 48 weeks prior to enrollment, allowing limited transient increases
• CD4+ count >450 cells/mm³ and CD4+ percentage ≥15%
• Willing and able to comply with study visits and procedures
• Agrees not to participate in another investigational study during participation unless approved
• In general good health, with no clinically significant findings on physical exam or laboratory testing
• Hemoglobin ≥11.0 g/dL (women) or ≥13.0 g/dL (men)
• Absolute neutrophil count ≥750/mm³
• Platelet count ≥100,000/mm³
• ALT <2.5 × upper limit of normal
• Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m²
• Serum creatinine ≤1.1 × upper limit of normal
• Serum calcium >8.5 mg/dL
• Blood pressure within acceptable limits
• Agrees to use condoms during the specified period when ART is interrupted until HIV RNA is undetectable
• No evidence of active hepatitis C infection
• No evidence of active hepatitis B infection
• For individuals of pregnancy potential: negative pregnancy test prior to enrollment and agreement to use effective contraception during the required study period
• Agreement not to seek pregnancy during the required study period

Ki nem vehet részt

• Current use of ART that includes non-nucleoside reverse transcriptase inhibitors (NNRTIs)
• Use of long-acting ART within 3 months prior to enrollment
• Resistance to one or more drugs in two or more ART classes (excluding M184V/I mutation)
• Previous receipt of an investigational HIV vaccine (prior placebo recipients allowed)
• Prior receipt of anti-HIV monoclonal antibody therapy
• Receipt of certain vaccines within restricted timeframes prior to enrollment (including live or mRNA vaccines within 4 weeks)
• Receipt of other vaccines within 14 days prior to enrollment
• Recent use of investigational agents within restricted timeframes prior to enrollment
• Initiation of ART during acute HIV infection (within 1 year of HIV acquisition, if known)
• History of severe HIV-related conditions, including opportunistic infections, HIV-associated cancers, lymphoma, neurocognitive disease, or progressive multifocal leukoencephalopathy
• Active or recent non-HIV-related cancer requiring systemic treatment within 36 months or expected need for treatment within 12 months (excluding minor skin cancers)
• Active hepatitis B or hepatitis C infection
• Significant liver disease, including cirrhosis or advanced fatty liver disease
• Untreated or incompletely treated active or latent tuberculosis
• Diabetes mellitus, except well-controlled type 2 diabetes as allowed
• History of or current atherosclerotic cardiovascular disease, including heart attack, angina, stroke, or peripheral arterial disease
• Receipt of a non-HIV investigational vaccine within 1 year, unless approved or licensed
• Conditions causing impaired immune function or use of immunosuppressive medications within the specified timeframe
• History of myocarditis or pericarditis
• Recent initiation of allergy immunotherapy within 1 year (unless stable or approved)
• History of severe allergic reaction to mRNA vaccines or polyethylene glycol-containing products
• History of angioedema
• History of urticaria associated with vaccination
• Bleeding disorders or use of systemic anticoagulants
• Conditions associated with increased risk of clotting or bleeding
• History of seizures within the past 3 years or use of anti-seizure medications within that period
• Any clinically significant medical, psychiatric, or substance use condition that may affect safety or study participation
• History of immune-mediated medical conditions, except limited stable or resolved conditions as allowed
• Allergy to local anesthetics (e.g., lidocaine)
• History of advanced HIV-related illness (CDC Category C), except recurrent pneumonia, within 10 years prior to screening, or history of CD4 count <200 cells/mm³ within the past 10 years
• Known resistance to any component of the current ART regimen (excluding M184V/I mutation)
• Pregnancy or breastfeeding
• Body mass index (BMI) ≥40 kg/m², unless approved
• Idiopathic urticaria within the past year
• Chronic urticaria or urticaria within the past year
• Absence of spleen or impaired splenic function
• Active duty or reserve military personnel (U.S.)
• Uncontrolled or severe asthma
• Difficulty with venous access that would interfere with study procedures