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Analytic Treatment Interruption (ATI) to Assess HIV Cure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02437526
Recruitment Status : Enrolling by invitation
First Posted : May 7, 2015
Last Update Posted : April 28, 2023
Sponsor:
Information provided by (Responsible Party):
Andrew D. Badley, M.D., Mayo Clinic

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
HIV Other: Analytic treatment interruption Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Analytic Treatment Interruption of Antiretroviral Therapy to Assess for HIV Cure
Study Start Date : May 2015
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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


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

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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437526


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

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Responsible Party: Andrew D. Badley, M.D., Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02437526    
Other Study ID Numbers: 15-001678
First Posted: May 7, 2015    Key Record Dates
Last Update Posted: April 28, 2023
Last Verified: April 2023
Keywords provided by Andrew D. Badley, M.D., Mayo Clinic:
Cure
Analytic treatment interruption