A5386: A Phase I Clinical Trial of the Safety, Tolerability, and Efficacy of IL-15 Superagonist (N-803) with and without Combination Broadly Neutralizing Antibodies to Induce HIV-1 Control During Analytic Treatment Interruption
HIV Control Study: ACTG 5386
Sponsor: NIH
Enrolling: Male and Female Patients
Study Length: 2 Years
Clinic Visits: 50
IRB Number: AAAS9605
U.S. Govt. ID: NCT04340596
Contact: Max Flanagan: 212-305-7897 / mhf2142@cumc.columbia.edu
Additional Study Information: Scientists are looking for ways to effectively clear HIV that rests in areas of the body where standard antiretroviral treatment (ART) is unable to reach. IL-15 superagonist (N-803) appears to reactivate HIV that is asleep and is also thought to increase the body's natural immune response to HIV. Broadly neutralizing antibodies (bNAbs), such as 10-1074 and VRC07-523LS, have been shown to control growth of HIV in the blood and to increase the body's immune response to HIV. N-803 alone or in combination with bNAbs may provide greater control of HIV than previous efforts. The purpose of this study is to investigate if N-803, a new experimental drug that stimulates the immune system, is safe and tolerable when given alone and in combination with two new experimental drugs (VRC07-523LS and 10-1074) that are antibodies (natural proteins that the body makes in response to an infection) to HIV (the virus that causes AIDS). This study will also look at how well HIV is controlled after stopping anti-HIV medications (also known as ART) in persons who received N-803 alone or N-803 with VRC07-523LS and 10-1074. One year after starting study treatment, participants will stop ART for up to 24 weeks to see how well their immune systems control growth of HIV. Participants will be followed closely to see if ART should be restarted. After restarting ART, participants will be followed for another 24 weeks. There are two study treatment groups of 23 people, for a total of 46 participants (ages 18 to 70 years old). If you join this study, you will be seen in the clinic up to 50 times in about 2 years. Procedures during your participation will include administration of the study drugs mentioned above, physical exams and vital signs, blood and urine tests at scheduled clinic visits for safety evaluations and to check your immune function. You will receive a minimum of approximately $2200 in total for the completion of all required study visits.
Michael Yin, MD
Do You Qualify?
Are you currently living with HIV? Yes No
Have you had a low or undetectable HIV viral load for the last 2 years? Yes No
Are you willing to temporarily stop taking antiretrovirals or ART? Yes No
You may be eligible for this study

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For more information, please contact:
Max Flanagan