MAY AWARENESS DAYS

ACTG Announces Launch of Clinical Trial Evaluating Combination of Three Novel Immune-based Therapies for HIV Cure

Study will enroll participants who initiated treatment shortly after acquiring HIV

Los Angeles, Calif. – ACTG, a global clinical trials network focused on HIV and other infectious diseases, today announced the opening of A5374, a phase 1/2a study evaluating the safety, tolerability, and antiviral effect of a novel combination regimen that includes therapeutic T-cell vaccines, two broadly neutralizing antibodies (bNAbs), and an immune-system boosting treatment among people living with HIV who started antiretroviral treatment (ART) during acute (early) HIV infection. A5374 (Triple Immune Strategy for HIV Remission) is a multi-site, randomized, placebo-controlled trial. The study hypothesizes that this combination regimen will be safe and result in a longer period of viral control during a closely monitored pause in ART (known as an analytic treatment interruption) compared to placebo.

While current ART can manage HIV very well, it does not cure it and people living with HIV have to take it for the rest of their lives in order to suppress viral replication and protect their immune systems. The approach being studied in A5374 is part of a potential path toward enabling the immune system to manage HIV in the absence of ART for weeks or months.

“We expect that controlling HIV in the absence of ART will require a combination of novel treatments to decrease the number of cells harboring HIV and simultaneously stimulate the immune system to keep the virus from replicating,” said ACTG Chair Judith Currier, M.D., M.Sc., University of California Los Angeles. “A5374 is a pivotal trial and we are hopeful that it will provide us with important insights into how to boost the immune system so that it can control HIV.”

A5374 will enroll 45 participants aged 18 years and older who started combination ART within 28 days of acute HIV diagnosis (30 who will receive active study treatment and 15 who will receive placebo). The study will last up to approximately two years for each participant.

After enrollment, participants will continue taking their HIV medications and will either receive a series of novel treatments or placebo. The novel regimen includes a T-cell vaccine regimen (vaccines vectored by replication-deficient chimpanzee adenovirus ChAdOx1 and poxvirus MVA, each containing six small fragments of HIV); broadly neutralizing antibodies (teropavimab, also known as GS-5423 or 3BNC117-LS, and zinlirvimab, also known as GS-2872 or 10-1074-LS); and vesatolimod (a toll-like receptor 7 or TLR7 agonist, which acts as an immune booster). After about 16 months in the study, participants will stop taking ART. They will be closely monitored for increases in HIV viral load, decreases in CD4 T-cell counts, and symptoms, and will resume taking ART if there is a signal that HIV is rebounding or if they become pregnant. The study will compare the length of time that participants in the active treatment and placebo groups experience viral control while they are off ART.

For more information about A5374, please visit clinicaltrials.gov. Read the full press release here.

Don't Miss Out, Register for the 2024 HPTN Annual Meeting!

Time is running out; register today if you plan on attending in person or remotely. The meeting will feature several plenaries, presentations, and discussions regarding HIV prevention, intersecting research, and interactive question-and-answer sessions. Study-specific protocol team meetings will also take place.

HOW TO ATTEND

All registered attendees will have access to the virtual Attendee Hub platform via desktop or mobile app. When starting the online registration process, select one of the following registration types based on your intended participation:

• In-Person - Select this option if you plan on attending in-person for at least one day. Upon check-in, you will receive a printed badge, agenda book, other materials, and full access to the virtual Attendee Hub.

• Remote - Select this option if you do not plan on joining us in Washington, D.C. You will have full access to the virtual Attendee Hub to view live plenaries and participate in virtual sessions.

WHO SHOULD ATTEND?

• Clinical Trial Units (CTUs)/Clinical Research Sites (CRS) Staff:
• Principal Investigators/Investigators of Record;
• Key study staff (community representative, community educators, study coordinators, study clinicians/nurses, laboratory representative, pharmacists).
• Investigators engaged in HIV prevention research.
• Advocates, allies, and community partners supporting HIV prevention efforts.

Note: The HPTN Leadership and Operations Center (LOC) has provided all supported travelers with a unique registration link. Please email us if you are still waiting to receive the registration link.

After registering, you will receive a confirmation email with links to book a hotel room and request a visa letter (if applicable). 

We look forward to seeing you!

Questions? We're here to help: 

HPTNannualmeeting@fhi360.org

Investigating Syphilis Treatment During Pregnancy

A clinical trial that will investigate syphilis treatments during pregnancy is under development. IMPAACT 2044 is a Phase IV, multi-site, open-label, non-randomized, opportunistic pharmacokinetic (PK) study of ceftriaxone (CTX) and benzathine penicillin G (BPG) in pregnancy for the treatment of syphilis. Participants with syphilis and receiving CTX or BPG as standard of care treatment (i.e., outside of the study) will be enrolled at study sites located in the United States. The study is designed to characterize the PK of CTX and BPG, as well as the kinetics of quantitative non-treponemal titer changes of BPG in each trimester of pregnancy. Participants will be actively followed for up to 14 days and will remain in the study until delivery or another pregnancy outcome.

Study Investigating RSV Vaccines in Children Closed to Follow-Up

IMPAACT 2021, a clinical trial testing vaccines to prevent respiratory syncytial virus (RSV) illness in children, has closed to follow-up after enrolling 67 participants from 14 clinical research facilities in the United States. Researchers hope to learn more about the safety and antibody response in children to the vaccines, which will inform the development of a vaccine that can prevent serious RSV illness. 

There are no HVTN updates at this time as preparations are made for the Full Group meeting May 1 - 3, 2024, in Washington, D.C.

Learn more about current HVTN clinical trials.

Behavioral and Social Sciences

Greg Davis HANC Project Manager

Community Coordination

Russell Campbell

HANC Director

Greg Davis

HANC Project Manager

Cross-Network Coordination

Kathleen Pescasio

HANC Cross-Network Project Manager

Laboratory Coordination

Tyler Brown

HANC Laboratory

Project Manager

The Legacy Project

Brian Minalga

HANC Deputy Director

Cat Banobi

Legacy Project Manager

Gabriella Olague

HANC Project Coordinator