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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years

Sex

ALL

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

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