Active — Not RecruitingPhase 2

Reducing HIV Persistence in Lymph Nodes by Interleukin-15 (IL-15) Receptor Super-agonist (N-803) in Acute HIV Infection

Thailand14 participantsStarted 2021-03-01

Plain-language summary

Reducing HIV persistence in lymph nodes by Interleukin-15 (IL-15) Receptor super-agonist (N-803) in Individuals with Acute HIV Infection

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age 18 years and above.
✓. Acute HIV infection (Fiebig I to V: Fiebig I: RNA+, p24 antigen-; Fiebig II: p24 antigen+, IgM-; Fiebig III: IgM+, Western Blot-; Fiebig IV: Western Blot indeterminate; Fiebig V: Western Blot+ without p31 protein band)
✓. All female participants of childbearing potential must have a negative urine pregnancy test at the screening visit
✓. Women of child bearing potential and men with partners of child bearing potential must agree to use effective contraception (as defined in section 8.1.2 Pregnancy Risks) during therapy and for 4 months after completion of therapy
✓. Can read and write Thai and/or English language and must be able to understand and complete the informed consent process
✓. Must successfully complete a Test of Understanding (TOU) prior to enrollment as described in Section 7.1
✓. Willing to undergo inguinal LN Bx at two time points (baseline and week 6) and blood draws during each study visit
✓. Willing to participate for the duration of the study visits and follow up.

Exclusion criteria

✕. 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
✕. Receipt of any vaccine within 2 weeks prior to study enrollment and anticipated need for any vaccine within 2 weeks prior to or after any of the study agent administrations.
✕. Current or anticipated use of systemic steroid medications.
✕. Any clinically significant acute or chronic medical condition, including, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, that in the opinion of the investigator would preclude participation (e.g., history of seizure disorders, cardiac disease, bleeding/clotting disorder, autoimmune disease, active malignancy, poorly controlled asthma, active tuberculosis or other systemic infections, etc.)
✕. Chronic liver disease
✕. 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, or (g) peripheral arterial disease presumed to be of atherosclerotic origin
✕. History of potential immune-mediated medical conditions

What they're measuring

Rate of occurrence of ≥ grade 3 adverse events determined to be related (Safety)

Timeframe: at time of study completion at week 12

Frequency of vRNA+ and vDNA+ cells and levels of vDNA and vRNA in LNs

Timeframe: At baseline (week 0) and week 6

Frequency, phenotype and function of CD8+ T cells and innate cells in LNs

Timeframe: At baseline (week 0) and week 6

Time (days) from ATI to first documented HIV-1 RNA viral rebound of ≥1000 copies/mL following ATI.

Timeframe: viral rebound during Step 2 ATI

Trial details

NCT IDNCT04505501

SponsorThai Red Cross AIDS Research Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-30

View on ClinicalTrials.gov More HIV/AIDS trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age 18 years and above.
✓. Acute HIV infection (Fiebig I to V: Fiebig I: RNA+, p24 antigen-; Fiebig II: p24 antigen+, IgM-; Fiebig III: IgM+, Western Blot-; Fiebig IV: Western Blot indeterminate; Fiebig V: Western Blot+ without p31 protein band)
✓. All female participants of childbearing potential must have a negative urine pregnancy test at the screening visit
✓. Women of child bearing potential and men with partners of child bearing potential must agree to use effective contraception (as defined in section 8.1.2 Pregnancy Risks) during therapy and for 4 months after completion of therapy
✓. Can read and write Thai and/or English language and must be able to understand and complete the informed consent process
✓. Must successfully complete a Test of Understanding (TOU) prior to enrollment as described in Section 7.1
✓. Willing to undergo inguinal LN Bx at two time points (baseline and week 6) and blood draws during each study visit
✓. Willing to participate for the duration of the study visits and follow up.

Exclusion criteria

✕. 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
✕. Receipt of any vaccine within 2 weeks prior to study enrollment and anticipated need for any vaccine within 2 weeks prior to or after any of the study agent administrations.
✕. Current or anticipated use of systemic steroid medications.
✕. Any clinically significant acute or chronic medical condition, including, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, that in the opinion of the investigator would preclude participation (e.g., history of seizure disorders, cardiac disease, bleeding/clotting disorder, autoimmune disease, active malignancy, poorly controlled asthma, active tuberculosis or other systemic infections, etc.)
✕. Chronic liver disease
✕. 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, or (g) peripheral arterial disease presumed to be of atherosclerotic origin
✕. History of potential immune-mediated medical conditions

What they're measuring

Rate of occurrence of ≥ grade 3 adverse events determined to be related (Safety)

Timeframe: at time of study completion at week 12

Frequency of vRNA+ and vDNA+ cells and levels of vDNA and vRNA in LNs

Timeframe: At baseline (week 0) and week 6

Frequency, phenotype and function of CD8+ T cells and innate cells in LNs

Timeframe: At baseline (week 0) and week 6

Time (days) from ATI to first documented HIV-1 RNA viral rebound of ≥1000 copies/mL following ATI.

Timeframe: viral rebound during Step 2 ATI