HIV
Conditions
Keywords
Cure, Analytic treatment interruption
Brief summary
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.
Interventions
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to virologic rebound | 38 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Time to HIV-1 RNA ≥ 20 copies/ml | 38 weeks |
| Time to HIV-1 RNA ≥ 100 copies/ml | 38 weeks |
Countries
United States
Outcome results
None listed