HIV Clinical Studies

These studies are conducted by the ACTG (Advancing Clinical Therapeutics Globally). If you are interested in participating in a study, call ACTG at (617) 726-3819 to speak with a member of the study team. If you would like to fill out an interest form for an actively enrolling study, visit our RALLY page. Always talk with your primary care provider about any study you are interested in to make sure it is right for you.

All Studies

ACTG A5374

This study is a phase I/IIa randomized, placebo-controlled trial of conserved-mosaic T-cell vaccine in a regimen with Vesatolimod and broadly neutralizing antibodies in adults initiated on suppressive antiretroviral therapy during acute HIV-1. This study is evaluating three new treatments given in sequence to improve the response of the

immune system to HIV allowing for longer periods in which the virus is controlled and in which daily HIV medication is not needed.

This research study is looking at a regimen of 3 experimental treatments:

• Two therapeutic vaccines will be given intramuscularly and may focus the immune system on the most vulnerable parts of HIV.
• The second agent, Vesatolimod is an oral therapy that may strengthen the body's immune response to HIV.
• Lastly, two broadly neutralizing antibodies (bNAbs) are administered through an IV and may target the virus and prevent its spread thoughout the body.

COPE (ACTG A5402)

This study is an open-label, randomized controlled trial of pramipexole versus escitalopram to treat major depressive disorder (MDD) and comorbid MDD with mild neurocognitive disorder (MND) in persons with HIV. This study seeks to improve treatment options for those living with HIV who are experiencing depression, with or without mild memory or thinking difficulties.

HoT (ACTG A5424)

This is a two-group study, where enrolled women living with Human Immunodeficiency Virus (HIV) on antiretroviral therapy (ART) will receive study medication called “Hormone replacement therapy (HT; estradiol gel with or without oral progesterone)” or placebo. The purpose of this study is to see if hormone therapy helps reduce hot flashes and night sweats, also known as vasomotor symptoms, in women living with HIV in the late menopausal transition (what is known as perimenopause) or early post-menopause.

iPACE-HIV (ACTG A5426)

This is a double-blind, placebo-controlled study to evaluate the safety and tolerability of dasatinib and quercetin (D+Q) and study this regimen’s effectiveness on improving physical ability in persons living with HIV. People living with HIV often experience signs of aging earlier than others. Dasatinib (D) and quercetin (Q) have been associated with improved physical function in some groups of older adults and could possibly improve impaired physical function among older people living with HIV.