Predictors of Time to Viremia With an Analytic Treatment Interruption

NCT03033017 | Withdrawn

• 1 other identifier: 24777
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

This is a two-center study of 30 HIV-infected participants who have been on antiretroviral therapy (ART) for at least two years. Participants will be asked to undergo LN and GALT biopsies both before and after a closely monitored analytic treatment interruption (ATI).

Conditions

HIV

Keywords

HIV

Outcome Measures

Primary Outcomes (8)

• Time to viremia

  Time to viremia

  Baseline to 14 days

• Change in vRNA+ and vDNA+ cells

  measured by in situ hybridization and using quantitative image analysis to determine the frequency of + cell/gram lymphoid tissue

  Baseline to 14 days

• SCA (Single Copy Assay)

  performed as described in the protocol and reported as number of cells/ml plasma.

  Baseline to 14 days

• Change in markers of immune activation

  All measurements are the same IL1B, TNF, IL4, IL13, IL17, IL21,IL22, IL6, IL10

  Baseline to 14 days

• Change in CD4

  Baseline to 14 days

• Change in CD4/CD8 ratio

  Baseline to 14 days

• Polyadenylation-RT-ddPCR assay for total transcripts (TAR)

  transcripts/million cells

  Baseline to 14 days

• ddPCR assays for read-through, elongated, polyadenylated, and multiply-spliced (Tat-Rev) transcripts

  reported as transcripts/million cells

  Baseline to 14 days

Study Arms (1)

HIV-infected on antiretroviral therapy 2 years

HIV-infected participants who have been on antiretroviral therapy (ART) for at least two years.

Other: Blood Testing

Interventions

Blood Testing OTHER

HIV-infected on antiretroviral therapy 2 years

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

30 HIV-infected participants who have been on antiretroviral therapy (ART) for at least two years.

You may qualify if:

• HIV-infected individuals who have been on ART therapy for at least two years
• Male or Female, aged 18 years or older
• Documented evidence of CD4+ T cell count ≥ 300 cells/µl for 12 months prior to study entry
• BMI ≤ 30 or evidence by ultrasound or physical exam of peripheral inguinal lymph node(s) that is/are surgically accessible
• Documented plasma HIV RNA levels below level of quantification \<20 to \<40 copies RNA/mL depending on the assay) ≥ 24 months (a single measurement above the level of detection but \< 200 copies/ml will be allowed)
• Willing to switch to an ART regimen consisting of dolutegravir and either tenofovir/emtricitabine or abacavir/lamivudine to avoid drugs with a long-half life that would expose the participant to a period of mono-therapy when the drugs are stopped.
• Women of child bearing potential and men with partners of child bearing potential must agree to use effective contraception during protocol
• Able to provide voluntary written consent.

You may not qualify if:

• ART was initiated during acute infection (within first 6 months of infection)
• Planning or current pregnancy or breastfeeding
• History and/or presence of any clinically significant disease or disorder, such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal and psychiatric/mental disease/disorder, which, in the opinion of the enrolling physician, may put the participant at risk because of participation in the study, influence the results of the study, or affect the participant's ability to participate in the study.
• Inability to comply with study procedures per enrolling physician discretion.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (2)

University of California

San Francisco, California, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Lymph node biopsy: Inguinal lymph node biopsies will be collected per institutional guidelines

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Timothy Schacker, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: January 26, 2017
• Study Start: July 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: December 4, 2017

Record last verified: 2017-12

Locations

US (2)