Analytic Treatment Interruption (ATI) to Assess HIV Cure

Mayo Clinic

Status: Invitation-only

Conditions: HIV

Treatments: Other: Analytic treatment interruption

Study type: Interventional

Funder types: Other

Identifiers

NCT02437526

15-001678

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Treatment interruption

Experimental group

Description:

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

Treatment:

Other: Analytic treatment interruption