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

• Status: Recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thai Red Cross AIDS Research Centre
• Collaborators: Henry M. Jackson Foundation for the Advancement of Military Medicine; Walter Reed Army Institute of Research (WRAIR)

Criteria

Inclusion Criteria:

1. Age 18-40 years

2. 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)

3. All female participants of childbearing potential must have a negative urine pregnancy test at the screening visit

4. 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

5. Can read and write Thai and/or English language and must be able to understand and complete the informed consent process

6. Must successfully complete a Test of Understanding (TOU) prior to enrollment as described in Section 7.1

7. Willing to undergo inguinal LN Bx at two time points (baseline and week 6) and blood draws during each study visit

8. Willing to participate for the duration of the study visits and follow up.

Exclusion Criteria:

1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study

2. 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

3. 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.

4. Current or anticipated use of systemic steroid medications.

5. 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.)

6. Chronic liver disease

7. 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

8. History of potential immune-mediated medical conditions

9. Serious illness requiring systemic treatment and/or hospitalization in the 3 months prior to study enrollment

10. Major psychiatric illness and/or substance use during the past 12 months that in the opinion of the investigator would preclude participation

11. Concurrent treatment with immunomodulatory drugs, and/or exposure to any immunomodulatory drug in the 4 weeks prior to study enrollment

12. Exposure to any experimental therapies within 90 days of study entry

13. Pre-exposure prophylaxis (PrEP) use within 90 days of study entry