Interleukin-15 to Promote Post-ART Control of HIV
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety - Solicited Adverse Events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
N-803
Participants in this arm will receive the active study drug during the blinded portion (Phase A) of the trial. They will receive the active study drug during the open-label portion (Phase B) of the trial.
干预措施: N-803 (Drug)
Placebo
Participants in this arm will receive placebo during the blinded portion (Phase A) of the trial. They will receive the active study drug during the open-label portion (Phase B) of the trial.
干预措施: Saline placebo (Drug)
结局指标
主要结局
Safety - Solicited Adverse Events
时间窗: 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
时间窗: Within 7 days after dosing.
Frequency and grade of unsolicited AEs.
次要结局
- Time to Rebound(52 weeks after treatment interruption.)
研究者
Michael Peluso, MD
Assistant Professor of Medicine
University of California, San Francisco