Trial studying safety and effects for HIV
Official 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
ClinicalTrials.gov ID: NCT07569029
What this study is testing
What is DV700P-RNA 100 mcg?
DV700P-RNA 100 mcg is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for hiv.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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.
You likely can't join if
- 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...
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Atlanta, Georgia, United States
- Decatur, Georgia, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Rochester, New York, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Buenos Aires, Buenos Aires, Argentina
- Lima, Lima Province, Peru
- Bellavista, Provincia Constitucional del Callao, Peru
- Harare, Zimbabwe
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Atlanta, Georgia, United States; Decatur, Georgia, United States; Boston, Massachusetts, United States; New York, New York, United States; Rochester, New York, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.