N-803 Combined With the Broadly Neutralizing Antibodies Plus or Minus haNK Cells for HIV

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Hiv, HIV/AIDS, HIV Infections, AIDS, AIDS and Infections, Aids/Hiv Problem

In brief

To assess the safety of combination immune therapy in HIV-infected participants whose HIV is controlled with ART, by determining the incidence and severity of adverse events.

Key facts

Study ID

NCT04144335

Run by

University of Minnesota

People needed

0

Starts

2020-01-01

Expected to finish

2020-12-31

Last updated by the study team

2020-10-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV-1 infection
• On continuous antiretroviral therapy for > 12 months without any interruptions of greater than 14 consecutive days in the last 12 months
• Screening plasma HIV RNA levels < 20 copies/mL on all available determinations in past 12 months (isolated single values ≥ 20 but < 200 copies/mL will be allowed if they were preceded and followed by viral load determinations < 20 copies/mL)
• Screening CD4+ T-cell count ≥ 400 cells/mm3

You may not qualify if…

• Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
• Active or recent malignancy requiring systemic chemotherapy or surgery in the preceding 36 months or for whom such therapies are expected in the subsequent 12 months; minor surgical removal of localized skin cancers (squamous cell carcinoma, basal cell carcinoma) are not exclusionary
• Chronic liver disease defined as Class B and C on the Child-Pugh scale
• Active and poorly controlled atherosclerotic cardiovascular disease (ASCVD), as defined by 2013 ACC/AHA guidelines, including a previous diagnosis of any of the following: (a) acute myocardial infarction, (b) acute coronary syndromes, (c) stable or unstable angina, (d) coronary or other arterial revascularization, (e) stroke, (f) transient ischemic attack (TIA), or (g) peripheral arterial disease grade IIa or greater
• History of AIDS-defining illness within the past 5 years
• History of potential immune-mediated medical conditions requiring concomitant treatment with immunomodulatory drugs, and/or exposure to any immunomodulatory drug in the 4 weeks prior to study enrollment
• Exposure to any experimental therapies within 90 days of study entry

Where it is running

• University of California — San Francisco, California, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Minnesota Medical Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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