HIVSTIsDiagnostics and screening
What this study is
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.
What's being tested
- Analytic treatment interruption
Intervention · OTHER
Study details
- Official title
- Analytic Treatment Interruption of Antiretroviral Therapy to Assess for HIV Cure
- Sponsor
- Mayo Clinic
- Conditions
- HIV
- Enrolling
- 10 people
- Starts
- 2015-05
- Est. completion
- 2035-05
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMayo Clinic in Rochester
Rochester, Minnesota, United States
Study team
Sponsor
Mayo Clinic
Study ID 15-001678
Principal investigator
Andrew Badley, MD
Mayo Clinic
Have questions? The record lists no central contact. Use Consider me and the site team can reach you, or find them through ClinicalTrials.gov ↗.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.