ACTG A5364: A Phase I, Open-Label Study of the Safety and Ability of Broadly Neutralizing Antibodies 3BNC117-LS and 10-1074-LS in Combination to Durably Prevent Viral Relapse During a Monitored Analytical Treatment Interruption
Treatment Category: Experienced
This is a Phase I, open-label, single-arm, multi-step study designed to evaluate the effects of the combination of long-acting broadly neutralizing antibodies (bNAbs) 3BNC117-LS and 10-1074-LS in participants living with HIV who discontinue anti-HIV therapy (ART) during a monitored analytical treatment interruption (ATI), which is an extended period of time when not taking regular ART to control HIV.
Study Status: Open to Accrual
Why is this study being done?
- To see if it is safe to give people 10-1074-LS and 3BNC117-LS, and to see if these study drugs cause any side
- To evaluate the efficacy of the study drugs in preventing the return of HIV levels in the blood after interrupting ART.
Who can join?
- People with HIV between 18 and 70 years old.
- On stable ART with an undetectable viral load for at least 48 weeks prior to study entry.
- Body weight between 110 and 250 lbs.
- Participants who can become pregnant must agree to use two methods of contraception during the
- Be willing to temporarily stop taking ART medications.
What do I need to do in the study?
After screening, eligible participants will undergo leukapheresis (a procedure in which blood is collected from a vein in one arm, processed through an attached machine, and then returned through a vein in the opposite arm), and will be asked if they are interested in optional procedures (flexible sigmoidoscopy with rectal biopsy and/or lumbar puncture to collect spinal fluid). Three additional leukapheresis procedures will be done during the study.
At study entry, participants will receive an infusion of 3BNC117-LS and an infusion of 10-1074-LS, and will discontinue ART 2 days later.
Stopping ART is not recommended in the context of standard clinical care and poses some level of risk to the participant and sexual partner(s). However, for this research study, participants will be monitored closely while they are not taking ART. They will have to start taking ART again if blood tests show that it is necessary. The ATI can last up to 24 weeks of frequent visits to see if ART should be restarted.
Each participant will be followed for 72 weeks.
What treatments or drugs are involved with this study?
10-1074-LS and 3BNC117-LS are antibodies to HIV. Many antibodies are naturally made by the body and help fight diseases. 10-1074-LS and 3BNC117-LS are made in a laboratory. They are called “monoclonal antibodies,” which means that they are made up of many copies of one single antibody.