Comparison of Dendritic Cell-Based Therapeutic Vaccine Strategies for HIV Functional Cure (NCT03758625) | Clinical Trial Compass
CompletedPhase 1
Comparison of Dendritic Cell-Based Therapeutic Vaccine Strategies for HIV Functional Cure
United States40 participantsStarted 2019-01-02
Plain-language summary
This study will be done in people living with HIV to see if an investigational vaccine made from a person's own white blood cells is safe and tolerated. This study will also look at the body's immune response to the vaccine and evaluate four different methods of making the vaccine to see which method may result in better immune responses.
Who can participate
Age range18 Years – 70 Years
SexALL
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
✓. HIV-1 infection, documented by any FDA-approved assay. NOTE: The term 'licensed' refers to a US FDA approved kit, which is required for all investigational new drug (IND) studies.
✓. Receiving continuous ART for at least 24 months (defined as no interruptions longer than 14 consecutive days) and with no changes in the components of the ART for at least 8 weeks prior to study entry. A change in formulation (for example tenofovir disaproxil fumarate to tenofovir alafenamide) will not be considered a change in ART.
✓. Screening CD4+ cell count ≥350cells/mm3 obtained within 60 days prior to study entry by any US laboratory that has a CLIA certification or its equivalent.
✓. Plasma HIV-1 RNA levels \< 50 copies/ml for at least 24 months prior to study entry using a FDA-approved assay performed by any laboratory that has a CLIA certification or its equivalent. Participants must have at least one documented HIV-1 RNA less than 50 copies/ml \>24 months prior to study entry and at least one HIV-1 RNA less than 50 copies/ml within 12 months prior to study entry. All available HIV-1 RNA measurements must be \< 50 copies/ml during the 24 months prior to study entry except as allowed by the following note.
✓. Screening HIV-1 RNA levels \<50 copies/mL using a FDA-approved assay performed by any laboratory that has a CLIA certification or its equivalent within 60 days prior to entry.
✓. Men and women age 18 to 70 years, inclusive.
✓. The following laboratory values obtained within 60 days prior to entry:
✓. Ability and willingness of participant to provide informed consent.
Exclusion criteria
What they're measuring
1
Safety and tolerability of six immunizations (10e7 DCs per dose) of DC-whole virus and DC-peptide vaccines in HIV-1 infected participants on effective ART
Timeframe: Step 2-Week 0 (overall Study Week 12) to overall Study Week 80
2
Efficacy of six immunizations (10e7 DCs per dose) of DC-whole virus and DC-peptide vaccines in HIV-1 infected participants on effective ART
Timeframe: Baseline to Step 2-Week 22 (overall Study Week 34)
✕. Known allergy/sensitivity or any hypersensitivity to components of study vaccine or their formulation.
✕. Known chronic inflammatory conditions such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, sarcoidosis, inflammatory bowel disease (i.e., Crohn's disease or ulcerative colitis), chronic pancreatitis, or autoimmune hepatitis, myositis, or myopathy.
✕. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
✕. Serious medical illness that requires systemic treatment and/or hospitalization within 30 days prior to entry.
✕. Use of systemic immunomodulators (eg, interleukins, interferons, cyclosporine), systemic cytotoxic chemotherapy, or investigational therapy within 60 days prior to study entry.
✕. Participation on any HIV immunotherapy or therapeutic vaccination trials within 6 months prior to study entry.
✕. History of positive HCV antibody with detectable HCV RNA in plasma within 48 weeks prior to study entry.