Analytic Treatment Interruption (ATI) to Assess HIV Cure

Enrolling by invitation · Not applicable

Conditions studied: HIV

In brief

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.

Key facts

Study ID

NCT02437526

Run by

Mayo Clinic

People needed

10

Starts

2015-05-01

Expected to finish

2035-05-01

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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