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Active Not Recruiting
NCT04340596
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
Conditions: HIV Infection
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 118
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Location: Alabama CRS (Site ID# 31788) Birmingham Alabama
Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of N-803, an IL-15 superagonist, with or without combination broadly neutralizing antibodies (bNAbs), to induce HIV-1 control during analytic treatment interruption (ATI).
Eligibility Criteria
Inclusion Criteria
* HIV-1 infection
* On ART for at least 96 weeks prior to randomization
* On ART regimen containing an integrase inhibitor and two nucleoside reverse transcriptase inhibitors (NRTIs) or dolutegravir/lamivudine for at least 6 weeks prior to randomization.
* CD4 cell count \>450 cells/mm\^3 within 90 days prior to randomization
* CD4 cell count nadir ≥200 cells/mm\^3.
* Plasma HIV-1 RNA levels of \50 kg and \
Source: ClinicalTrials.gov (NCT04340596). StuddyBuddy aggregates publicly available trial information.
