Analytic Treatment Interruption (ATI) to Assess HIV Cure

June 3, 2025 updated by: Andrew D. Badley, M.D., Mayo Clinic

Analytic Treatment Interruption of Antiretroviral Therapy to Assess for HIV Cure

This study is designed to determine if individual patients with HIV infection have been cured of the infection. To do this, antiretroviral therapy is discontinued under close medical supervision and the patient monitored over time for reactivation of infection.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Age ≥ 18 years
  • HIV-1 infected with the potential to have been cured of infection in the course of routine clinical care in the opinion of the treating physician and study team
  • Have an undetectable plasma HIV-1 RNA and undetectable proviral DNA on suppressive antiretroviral therapy on at least two consecutive measures for at least 6 months
  • Able and willing to either abstain from sexual activity or use barrier contraceptives during the ATI
  • Negative serum β-HCG pregnancy test in women with childbearing potential
  • Have the ability to give appropriate informed consent.

Exclusion Criteria

  • Women who are pregnant or nursing
  • Women who can become pregnant who are unable or unwilling to use both barrier and pharmacologic contraceptives during the ATI
  • Previous or current infections that are at high risk of reactivating with immune suppression, in whom there are no effective antimicrobial prophylaxis options
  • Advanced cardiopulmonary or liver disease
  • History of untreated solid or hematologic malignancies
  • Evidence of active viral replication in patients co-infected with Hepatitis B virus (HBV). Treatment should be provided to suppress HBV replication with agents that do not have activity against HIV (ie entecavir) prior to consideration for ATI.
  • Evidence of viral replication with Hepatitis C virus (HCV), together with evidence of any hepatic fibrosis or inflammation. Such patients should be offered HCV treatment first.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment interruption
Antiretroviral therapy will be discontinued under close laboratory monitoring and clinical supervision.
Other: Analytic treatment interruption

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to virologic rebound
Time Frame: 38 weeks
38 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to HIV-1 RNA ≥ 20 copies/ml
Time Frame: 38 weeks
38 weeks
Time to HIV-1 RNA ≥ 100 copies/ml
Time Frame: 38 weeks
38 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Andrew Badley, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Estimated)

May 1, 2035

Study Completion (Estimated)

May 1, 2035

Study Registration Dates

First Submitted

May 5, 2015

First Submitted That Met QC Criteria

May 6, 2015

First Posted (Estimated)

May 7, 2015

Study Record Updates

Last Update Posted (Estimated)

June 5, 2025

Last Update Submitted That Met QC Criteria

June 3, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 15-001678

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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