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.