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Analytic Treatment Interruption (ATI) to Assess HIV Cure

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Andrew D. Badley, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02437526
First received: May 5, 2015
Last updated: March 21, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention
HIV Other: Analytic treatment interruption

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
Official Title: Analytic Treatment Interruption of Antiretroviral Therapy to Assess for HIV Cure

Resource links provided by NLM:


Further study details as provided by Andrew D. Badley, M.D., Mayo Clinic:

Primary Outcome Measures:
  • Time to virologic rebound [ Time Frame: 38 weeks ]

Secondary Outcome Measures:
  • Time to HIV-1 RNA ≥ 20 copies/ml [ Time Frame: 38 weeks ]
  • Time to HIV-1 RNA ≥ 100 copies/ml [ Time Frame: 38 weeks ]

Estimated Enrollment: 10
Study Start Date: May 2015
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment interruption
Antiretroviral therapy will be discontinued under close laboratory monitoring and clinical supervision.
Other: Analytic treatment interruption

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02437526

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Andrew Badley, MD Mayo Clinic
  More Information

Responsible Party: Andrew D. Badley, M.D., Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02437526     History of Changes
Other Study ID Numbers: 15-001678
Study First Received: May 5, 2015
Last Updated: March 21, 2017

Keywords provided by Andrew D. Badley, M.D., Mayo Clinic:
Cure
Analytic treatment interruption

ClinicalTrials.gov processed this record on July 26, 2017