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

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT05584397
Status
Enrolling By Invitation

Conditions

  • HIV
  • HIV Disease Progression
  • HIV-1-infection
  • Inflammation

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Venipuncture — PROCEDURE
    Draw of peripheral blood (about 20 ml and 40 ml, during the screening and procedure visits, respectively).
  • Targeted physical medical exam — PROCEDURE
    Study participants will be undergoing a physical exam where vitals will be recorded (e.g. temperature, blood pressure, heart rate). The registered nurse (RN) will also perform auscultation of heart and lungs. Study participants will be also asked to fill out a survey with questions related to his/her medical history, current use of medications, sexual history and substance abuse.
  • Urine pregnancy test — PROCEDURE
    Women of childbearing potential will be asked to run an urine pregnancy test during the second (procedure) visit. Pregnant women will not be allowed to participate in the study.
  • Anoscopy — PROCEDURE
    The anoscopy is an examination using a small, rigid, tubular instrument called anoscope (also called an anal speculum). This is inserted a few inches into the rectum in order to collect some small samples of mucosal tissue. We will collect 5 rectum biopsy samples and one cytobrush.
  • Esophagogastroduodenoscopy (EGD) — PROCEDURE
    The EGD involves looking at the esophagus, stomach, and first and second portion of the duodenum. This procedure involves the use of an endoscope to remove small tissue samples. This procedure uses conscious sedation drugs given by a vein in the arm. The procedure takes about 1½-2 hours, including time for recovery. We will collect 5 duodenal biopsies and one cytobrush.

Study Details

The goal of the project is to determine the difference in immune activation and HIV reservoir size between People living with HIV (PWH) on tenofovir-containing antiretroviral therapy (ART) versus PWH on nucleoside reverse transcriptase inhibitor (NRTI)-sparing ART. Tenofovir (TFV), a phosphonated nucleoside reverse transcriptase inhibitor (NRTI), is being used for oral pre-exposure prophylaxis (PrEP). The investigators will test this hypothesis: tenofovir, and perhaps NRTIs in general, stimulate a type I/III interferon also in PWH who take these drugs. Because chronic interferon stimulation may promote the survival and proliferation of cells with integrated provirus, the investigators also hypothesize that these drugs antagonize decay of the HIV latent reservoir in PWH on ART. Consequently, the researchers hypothesize that PWH who have switched from NRTI-containing ART to NRTI-sparing ART exhibit lower type I/III interferon pathway activation and lower latent HIV reservoir size. The investigators also hypothesize that independently of treatment, the extent of type I/III interferon activation correlates with latent HIV reservoir size. Thus, the proposed study seeks to answer these two questions. Can the gastrointestinal epithelium be impacted by ART, and contribute to chronic immune activation and expansion of the HIV-1 reservoir? If so, what therapeutic approaches can the investigators implement to reduce the HIV-1 proviral load? The data will reveal pathways that can be targeted therapeutically to treat chronic immune activation in PWH. The findings of this study will immediately translate to optimize the standard of care in PWH.

Key Dates

Start date
Sep 1, 2022
Status verified
Apr 2026
Primary completion
Jul 30, 2026
Completion
Aug 28, 2026

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: Tenofovir-containing ART
    Cohort 1: Tenofovir-containing ART (tenofovir disoproxil fumarate \[TDF\] OR tenofovir alafenamide \[TAF\] PLUS any other ART drugs) prescribed for daily use by participants' primary care providers.
  • Arm: NRTI-sparing ART
    Cohort 2: NRTI-sparing ART (specifically: rilpivirine PLUS dolutegravir OR rilpivirine PLUS cabotegravir) prescribed for daily use by participants' primary care providers.

Primary Outcome Measure

Type I/III Interferon pathway activation [ Time Frame: 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. ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Washington Positive Research and the Gastroenterology Clinic at Harborview Medical CenterSeattleWashington98104-

Find similar trials in Seattle, WA

By condition
HIV
By specialty
Infectious disease
By research site
University of Washington Positive Research and the Gastroenterology Clinic at Harborview Medical Center· Seattle, WA

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