A Trial to Evaluate the Safety and Tolerability of DV700P-RNA and DV701B1.1-RNA Immunization in C… (NCT07569029) | Clinical Trial Compass
Not Yet RecruitingPhase 1
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
United States, Argentina, Peru42 participantsStarted 2026-06-02
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \<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.
Exclusion …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Local reactogenicity following study product administration
Timeframe: 14 days following each vaccination
2
Systemic reactogenicity following study product administration
Timeframe: 14 days following each vaccination
3
Number and description of serious adverse events (SAEs)
Timeframe: Through study completion, expected to be up to 88 weeks
4
Number and description of medically attended adverse events (MAAEs)
Timeframe: Through study completion, expected to be up to 88 weeks
5
Number and description of adverse events of special interest (AESIs)
Timeframe: Through study completion, expected to be up to 88 weeks
6
Number and description of adverse events leading to study product discontinuation or participant withdrawal
Timeframe: Through study completion, expected to be up to 88 weeks
7
Number and description of adverse events (AEs) following study product administration
Trial details
NCT IDNCT07569029
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)