Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingPhase 2interventionalRules rewrite

Phase 2: Acute Treatment Interruption for HIV

Background: Human immunodeficiency virus (HIV) infects CD4 T cells. People with HIV need to take daily medications called antiretroviral therapy (ART) to control their infection.

Official registry: https://clinicaltrials.gov/study/NCT05419024 · National Cancer Institute (NCI) · enrollment listed as 50

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Acute Treatment Interruption. The registry lists allocation as randomized. Background: Human immunodeficiency virus (HIV) infects CD4 T cells.

They plan to enroll about 50 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption

Interventions: Acute Treatment Interruption

Primary outcome (registry wording): Fold increase in HIV nucleic acids (RNA and DNA) in blood or lymphoid compartments from baseline to 10 day ATI vs baseline to no ATI.

Who it is for (from inclusion criteria)

  • Ages 18 Years to 100 Years
  • Participants must meet all of the following criteria to be eligible for this study:
  • People with HIV-1 documented using US Food and Drug Administration-approved screening and confirmatory or supplemental assays in Centers for Disease Control and Prevention (CDC)-recommended testing strategies
  • Established medical care outside NIH
  • Willing to allow samples to be stored for future research
  • Willing to allow genetic testing
  • Undergoing cART using recommended, alternative, or other regimens as defined by "Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV."
  • Viral RNA \<40 copies/mL plasma by conventional assay for at least 3 years (blips \[transient increases within 6 weeks\] of \<200 copies/mL are allowable when succeeding viral levels return to \<40 copies/mL on subsequent testing)

Public study contact (from the registry)

Chuen-Yen C Lau, M.D.

(240) 858-7088

lauc@mail.nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT05419024 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05419024?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05419024?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary