Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antire… (NCT04985760) | Clinical Trial Compass
CompletedPhase 1
Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy
United States32 participantsStarted 2021-09-30
Plain-language summary
Trimer 4571 is a vaccine designed to stimulate the development of broadly neutralizing antibodies (bnAbs) against HIV. Trimer 4571 is investigational, meaning it is not approved by the US Food and Drug Administration (FDA). There is limited human experience with the Trimer 4571 vaccine administered with aluminum hydroxide (alum) and the vaccine has not been tested in people with HIV prior to this study although it has been tested in healthy volunteers. The goal of this study is to see if Trimer 4571 is safe and well tolerated and to see if it will help the immune system produce bnAbs against HIV.
Who can participate
Age range18 Years
SexALL
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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 antiretroviral therapy (ART) for at least 24 months (defined as no interruptions longer than 30 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 ≥200cells/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 on ART 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 \< 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 ages \> 18 years.
✓
What they're measuring
1
Safety and tolerability of three vaccinations of Trimer 4571 vaccine in adults with HIV on suppressive ART
. The following laboratory values obtained within 60 days prior to entry:
✓. Ability and willingness of participant to provide informed consent.
Exclusion criteria
✕. Known to have been started on antiretroviral therapy within 3 months of the presumed or known date of first acquiring HIV-1 infection; i.e., treated during acute HIV-1 infection
✕. Currently breastfeeding or pregnant
✕. 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 (e.g., interleukins, interferons, Cyclosporine), systemic cytotoxic chemotherapy, or investigational therapy within 60 days prior to study entry.
✕. Receipt of any investigational HIV immunotherapy or HIV therapeutic vaccination within 12 months prior to study entry.