Analytic Treatment Interruption (ATI) to Assess HIV Cure

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.