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.
- 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.
- 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