Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT07569029

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

Conditions: HIV

Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 42
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Location: Alabama CRS (Site ID: 31788) Birmingham Alabama

Summary

This phase 1 study will evaluate the safety, tolerability, and immune responses of two experimental mRNA HIV vaccines in adults living with HIV who are in overall good health. The study will enroll about 42 participants at multiple study sites. Researchers will assess whether these vaccines can start or strengthen antibody responses against HIV. The study will also evaluate how a closely monitored planned pause in antiretroviral therapy affects these immune responses.

Eligibility Criteria

Inclusion Criteria: * 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 \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 \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. Exclusion Criteria: * Current use of ART that includes non-nucleoside reverse transcriptase inhibitors (NNRTIs). * Use of long-acting ART within 3 months prior to enrollment. * Known resistance to any component of the current ART regimen (excluding M184V/I mutation). * Resistance to one or more drugs in two or more ART classes (excluding M184V/I mutation). * Initiation of ART during acute HIV infection (within 1 year of HIV acquisition, if known). * History of advanced HIV-related illness (CDC Category C), except recurrent pneumonia, within 10 years prior to screening, or history of CD4 count \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07569029). StuddyBuddy aggregates publicly available trial information.