Analytic Treatment Interruption (ATI) to Assess HIV Cure

NCT02437526 | Enrolling By Invitation

• 1 other identifier: 15-001678
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

Cure; Analytic treatment interruption

Outcome Measures

Primary Outcomes (1)

• Time to virologic rebound

  38 weeks

Secondary Outcomes (2)

• Time to HIV-1 RNA ≥ 20 copies/ml

  38 weeks

• Time to HIV-1 RNA ≥ 100 copies/ml

  38 weeks

Study Arms (1)

Treatment interruption

EXPERIMENTAL

Antiretroviral therapy will be discontinued under close laboratory monitoring and clinical supervision.

Other: Analytic treatment interruption

Interventions

Analytic treatment interruption OTHER

Treatment interruption

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Andrew Badley, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 5, 2015
• First Posted: May 7, 2015
• Study Start: May 1, 2015
• Primary Completion (Estimated): May 1, 2035
• Study Completion (Estimated): May 1, 2035
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)