Analytic Treatment Interruption (ATI) to Assess HIV Cure

Study Overview
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Brief Summary
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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.

Official Title
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Analytic Treatment Interruption of Antiretroviral Therapy to Assess for HIV Cure

Conditions
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HIV

Intervention / Treatment
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* Other: Analytic treatment interruption


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment interruption<br>Antiretroviral therapy will be discontinued under close laboratory monitoring and clinical supervision. | Other: Analytic treatment interruption<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to virologic rebound |  | 38 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to HIV-1 RNA ≥ 20 copies/ml |  | 38 weeks | 
| Time to HIV-1 RNA ≥ 100 copies/ml |  | 38 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cure, Analytic treatment interruption