Analytic Treatment Interruption (ATI) to Assess HIV Cure

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 15-001678
    NCT ID: NCT02437526
    Sponsor Protocol Number: 15-001678

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Andrew Badley, M.D.

Closed for enrollment

Contact information:

Andrew Badley M.D.

(507)284-3309

.
CLS-20306496

Mayo Clinic Footer