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NCT05584397

Comparing Immune Activation and Latent HIV Reservoir Size Between People Living With HIV on Tenofovir-containing Versus NRTI-free ART

Enrolling by Invitation
Not specifiedAges 18–65Observational
University of Washington
~40 participants
Updated 2026-04-29 on ClinicalTrials.gov
What's tested:VenipunctureTargeted physical medical examUrine pregnancy testAnoscopyEsophagogastroduodenoscopy (EGD)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Type I/III Interferon pathway activation
Measured over Biopsy samples to assess interferon pathway activation will be collected during surgery. The assessment of this outcome (the determination of mRNA copy number) will be done around within one year of completing sample collection.
+2 more outcomes measured

Conditions

HIV-1-infection
HIV Disease Progression
Inflammation
HIV

Explore related trials

HIV Infection

Where it's being run

1 sites across 1 states
Washington1

Study leadership

  • German G Gornalusse, PhD, MSc · PRINCIPAL_INVESTIGATOR · University of Washington
  • Florian Hladik, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Washington
  • Romel D Mackelprang, PhD, MSc · PRINCIPAL_INVESTIGATOR · University of Washington

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Hemoglobin \< 8.5 mg/dL
Platelet count \< 100,000/μL
Coagulation (PT/PTT) tests above the normal reference
Creatinine clearance \< 60 mL/min 13. Using disallowed medications:
Systemic corticosteroids
Other immunosuppressive medications (e.g., cyclosporine, sirolimus, tacrolimus, pimecrolimus, tofacitinib) 14. BMI \> 40 15. Pulmonary dysfunction. 16. Use of narcotics.

What this trial measures

  • Type I/III Interferon pathway activationBiopsy samples to assess interferon pathway activation will be collected during surgery. The assessment of this outcome (the determination of mRNA copy number) will be done around within one year of completing sample collection.

    Quantification of the mRNA copy number of the following Interferon-Stimulated Genes (ISGs): ISG15 (ISG15 ubiquitin-like modifier), MX1 (MX dynamin-like GTPase 1) and IFI6 (interferon alpha inducible protein 6). Copy numbers will be determined by Crystal digital PCR (dPCR), using the levels of UBC (Ubiquitin C) mRNA copies as normalizers.

  • Size of the latent intact proviral HIV reservoir in cell-associated HIV DNA (Ca-DNA)Blood samples to assess the latent HIV reservoir will be collected during surgery. The assessment of this outcome (the determination of HIV copy number) will be done around within one year of completing sample collection.

    Determination of size (copy number) of the HIV proviral intact reservoir using a recently published assay the Hladik's lab conjointly with Jerome's lab developed (reference: Levy et al., 2021, Cell Reports Medicine 2, 100243). This outcome will be expressed as intact HIV copy numbers (found in cell-associated HIV DNA) per 10\^6 T cells. We will use a multiplexed digital PCR (dPCR) assay that simultaneously quantifies likely intact HIV-1 proviruses and T lymphocytes. We designed two triplex droplet digital PCR assays, each with 2 unique targets and 1 in common, and normalize the results to PCR-based T cell counts. Both HIV assays are specific, sensitive, and reproducible. Together, they estimate the number of proviruses containing all five primer-probe regions.

  • Size of the latent defective proviral HIV reservoir in cell-associated HIV DNA (Ca-DNA)Blood samples to assess the latent HIV reservoir will be collected during surgery. The assessment of this outcome (the determination of HIV copy number) will be done around within one year of completing sample collection.

    Determination of size (copy number) of the HIV proviral defective reservoir using a recently published assay the Hladik's lab conjointly with Jerome's lab developed (reference: Levy et al., 2021, Cell Reports Medicine 2, 100243). This outcome will be expressed as defective HIV copy numbers (found in cell-associated HIV DNA) per 10\^6 T cells.