A Study to Evaluate the Safety and Effects of Repeated Doses of 3BNC117-LS and 10-1074-LS on Pers… (NCT05612178) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study to Evaluate the Safety and Effects of Repeated Doses of 3BNC117-LS and 10-1074-LS on Persistent Viral Reservoirs in People Living With HIV and on Suppressive Antiretroviral Therapy
United States105 participantsStarted 2023-07-26
Plain-language summary
Background:
Antiretroviral therapy (ART) can suppress HIV to undetectable levels in people, but the virus rebounds quickly if the drug treatment is stopped; this is because HIV can remain dormant in a pool of blood cells called the persistent viral reservoir (PVR). Yet lifelong ART is expensive and can lead to serious side effects over the long term. Some drugs may be more effective at reducing the PVR.
Objective:
To see if 2 study drugs (3BNC117-LS and 10-1074-LS) are safe and if they can lower the number of HIV-infected blood cells in people with HIV who are on ART.
Eligibility:
People aged 18 to 70 years with HIV who are on ART.
Design:
Participants will be screened. They will have a physical exam and blood and urine tests. They will undergo leukapheresis. Leukapheresis is a procedure where blood is drawn from a needle in one arm. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be given back through a second needle in the other arm.
The study drugs or placebo (normal saline) will be administered 3 times at 20-week intervals. The drugs will be given through a tube attached to a needle inserted into a vein in the arm. This will take 1 hour. Some participants will receive only a saline solution. They will not know if they are getting the drugs or the placebo.
Participants will undergo leukapheresis up to 4 more times during the study.
Participants will have follow-up visits every 10 weeks until the study ends.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Ability to provide informed consent;
✓. Stated willingness to comply with all study procedures and availability for the duration of the study;
✓. Adult persons of any sex or gender, aged 18 years to 70;
✓. Confirmed HIV-1 infection and clinically stable;
✓. On antiretroviral therapy with plasma HIV-1 RNA levels of \< 50 copies/mL and no reported interruption of ART for 7 consecutive days or longer for at least 96 weeks. NOTE: At least two viral load (VL) measurements within 48 weeks prior to the screening visit must be available for review. A single plasma HIV-1 RNA \> 50 copies/mL but \< 200 copies/mL over 48 weeks that is followed by an HIV-1 RNA \< 50 copies/mL is permitted;
✓. Current CD4+ T cell counts \> 300 cells/mcL;
✓. For participants who can become pregnant (i.e., participants who have not been postmenopausal for at least 24 consecutive months, who have had menses within the preceding 24 months, or who have not undergone surgical sterilization, specifically hysterectomy and/or bilateral oophorectomy), must have a negative pregnancy test at screening and within 48 hours prior to day 0; NOTE: Participant-reported history is acceptable as documentation of hysterectomy and bilateral oophorectomy, tubal ligation, tubal micro-inserts, and vasectomy.
What they're measuring
1
Solicited and unsolicited grade 3 or higher adverse events
Timeframe: Week 0 to End of Study
Trial details
NCT IDNCT05612178
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Participants who can become pregnant must agree to use adequate measures to prevent pregnancy. This includes the use an effective method of contraception for the study duration. Contraception must be used from 10 days prior to the first dose of the investigational products (IPs), while receiving the IPs and during study follow up. Acceptable methods of contraception include:
Exclusion criteria
✕. History of AIDS-defining illness within 3 years prior to enrollment;
✕. History of systemic corticosteroids (e.g., an equivalent dose of prednisone of \> 20 mg daily for \>14 days), immunosuppressive anti-cancer, interleukins, systemic interferons, systemic chemotherapy or other medications considered significant by the trial physician within the last 6 months;
✕. Any clinically significant acute or chronic medical condition (e.g. such as autoimmune diseases, cirrhosis, active malignancy that may require systemic chemotherapy or radiation therapy), other than HIV infection, that in the opinion of the investigator would preclude participation;
✕. Hepatitis B or C infection as indicated by the presence of Hepatitis B surface antigen (HBsAg) or hepatitis C virus RNA (HCV-RNA) in blood. NOTE: Participants with a positive test for HCV antibody and a negative test for HCV RNA are eligible;
✕. Participants with known hypersensitivity to any constituent of the investigational products;
✕. Pregnancy or lactation;
✕. ART initiated during acute infection (defined as p24, HIV nucleic acid amplification technique \[NAAT\], or HIV RNA PCR positive, and negative or indeterminate HIV antibody testing);
✕. Laboratory abnormalities in the parameters listed below: