What is this study trying to find out about HIV?

This study is evaluating two experimental mRNA vaccines to see if they can safely start or boost antibody responses against HIV in adults living with the infection. Researchers also want to understand how a planned pause in antiretroviral therapy affects these immune responses. The National Institute of Allergy and Infectious Diseases sponsors this research to advance HIV treatment science.

Who may be eligible for this HIV clinical trial?

Adults aged 18 to 60 years with documented HIV infection may be eligible. Participants should be in overall good health and on stable antiretroviral therapy for at least 48 weeks with controlled viral load. Both males and females can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this HIV clinical trial?

Study-related care, including the study vaccines and all trial visits, is provided at no cost. However, personal travel and other expenses are the participant's responsibility and may vary. Participants should plan accordingly for these costs.

Actively Recruiting

Phase 1

Age: 18Years - 60Years

All Genders

ID07569029

Phase 1 Study of DV700P-RNA and DV701B1.1-RNA Vaccines with Planned Antiretroviral Therapy Pause in Adults Living with HIV

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-08-06

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, tolerability, and immune responses of two experimental mRNA HIV vaccines in adults living with HIV who are generally healthy. This phase 1 clinical trial aims to determine if these vaccines can initiate or boost antibody responses against HIV. The study also examines how a closely monitored planned pause in antiretroviral therapy ATI influences these immune responses. Participants will receive a series of vaccine injections one group receives DV700P-RNA at weeks 0 and 8, followed by DV701B1.1-RNA at week 16 another group receives DV700P-RNA at week 0 and DV701B1.1-RNA at week 8. Each vaccine is given by intramuscular injection. The trial uses a sequential design with no randomization or masking. During the study, participants will undergo assessments of local and systemic reactions following vaccinations, monitoring for serious and medically attended adverse events through up to 88 weeks. Immune responses will be measured by analyzing antibody levels and B-cell activity at baseline, after vaccinations, and after restarting antiretroviral therapy. The study involves multiple visits for vaccinations and monitoring, lasting approximately up to 88 weeks in total.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 60Years

All Genders

Eligibility Criteria

You may qualify if you...

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 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 ≥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.

You will not qualify if you...

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 <200 cells/mm³ within the past 10 years.
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.
Pregnancy or breastfeeding.
Body mass index (BMI) ≥40 kg/m², unless approved.
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.
Previous receipt of an investigational HIV vaccine (prior placebo recipients allowed).
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.
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.
History of myocarditis or pericarditis.
Recent initiation of allergy immunotherapy within 1 year (unless stable or approved).
Recent use of investigational agents within restricted timeframes prior to enrollment.
History of severe allergic reaction to mRNA vaccines or polyethylene glycol-containing products.
History of angioedema.
Idiopathic urticaria within the past year.
Chronic urticaria or urticaria within the past year.
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.
Absence of spleen or impaired splenic function.
Active duty or reserve military personnel (U.S.).
Any clinically significant medical, psychiatric, or substance use condition that may affect safety or study participation.
Uncontrolled or severe asthma.
History of immune-mediated medical conditions, except limited stable or resolved conditions as allowed.
Allergy to local anesthetics (e.g., lidocaine).
Difficulty with venous access that would interfere with study procedures.

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Phase 1 Study of DV700P-RNA and DV701B1.1-RNA Vaccines with Planned Antiretroviral Therapy Pause in Adults Living with HIV

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria