HIV
Conditions
Keywords
HIV, IL-15, N-803, Anktiva
Brief summary
Even though HIV medicine stops the virus from making more copies of itself, the virus remains in the body by hiding inside of immune cells. This hidden virus is referred to as the "latent reservoir." Researchers on this team are studying whether stimulating the immune system can change the nature of the latent reservoir and if this could help people control HIV without the need to take regular HIV medicine. This study is testing a drug called N-803. N-803 is also known as Interleukin-15 or "IL-15", a powerful and long lasting protein that can affect the immune system by stimulating immune cells such as CD8+ T cells and natural killer (NK) cells. CD8+ T cells and NK cells are both crucial for eliminating infected cells. The drug is FDA-approved for the treatment of bladder cancer, but in this study the drug is being used experimentally for HIV.
Interventions
DRUGN-803
This is the active drug.
DRUGSaline placebo
This is the placebo.
Sponsors
Michael Peluso, MD
amfAR, The Foundation for AIDS Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Age ≥ 18 and ≤ 70 years at the time of screening * Documented HIV-1 infection * On continuous ART for at least 6 months without any interruptions of greater than 14 consecutive days within the preceding 6 months * Plasma HIV RNA levels less than 200 copies/mL at each determination in the previous 6 months * Screening CD4+ T-cell count ≥ 350 cells/mm3 * Willingness to interrupt ART as part of the study transient treatment interruption
Exclusion criteria
* On an ART regimen that includes a non-nucleoside reverse transcriptase inhibitor, unable to switch to a different regimen * Receipt of any long-acting ART medication (e.g., injectable cabotegravir/rilpivirine, lenacapavir) in the two years preceding screening. * Known resistance to two or more classes of ART drugs and/or the inability to construct another fully suppressive regimen * Evidence of HIV "elite" control immediately prior to ART initiation * Screening platelets \< 125,000/mm3 * Screening hemoglobin \< 12.5 g/dL for men and \<11.5 for women * History of an AIDS-defining illness according to CDC criteria * History of HIV-associated malignancy * Non-HIV-associated malignancy requiring systemic chemotherapy or surgery in the 36 months preceding screening, or for whom such therapies are expected in the subsequent 12 months. * Active Hepatitis B (Hep B) infection (defined as Hep B surface antigen (sAg) positive or HBV DNA positive) * Active Hepatitis C (Hep C) infection (defined as Hep C Ab positive or indeterminate with detectable Hep C RNA) * Chronic liver disease * Chronic kidney disease * Active and poorly controlled atherosclerotic cardiovascular disease * QTc interval \>450msec (male) or \>470msec (female) * Pregnant, breastfeeding, or unwilling to use contraception to prevent pregnancy during participation in the study and until 6 months resumption of ART * Unable or unwilling to use barrier protection or pre-exposure prophylaxis (PrEP) in the partner, with sexual partners not known to have HIV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety - Solicited Adverse Events | Within 7 days after dosing. | Frequency and grade of each solicited systemic reactogenicity AE (malaise, participant-measured body temperature, fatigue, headache, chills, nausea, muscle aches/pain, joint pain). |
| Safety - Unsolicited Adverse Events | Within 7 days after dosing. | Frequency and grade of unsolicited AEs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Rebound | 52 weeks after treatment interruption. | Difference in time-to-viral rebound, defined as the first of two consecutive viral loads \> the limit of quantification of the assay, between those who previously received the intervention and those who previously received placebo. |
Countries
United States
Outcome results
None listed