Analytic Treatment Interruption (ATI) to Assess HIV Cure

HIV Clinical Trial

Official title:

Analytic Treatment Interruption of Antiretroviral Therapy to Assess for HIV Cure

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02437526
• Other study ID #: 15-001678
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 2015
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß-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.

Related Conditions & MeSH terms

• HIV

Intervention

Other:
• Analytic treatment interruption

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to virologic rebound		38 weeks
Secondary	Time to HIV-1 RNA = 20 copies/ml		38 weeks
Secondary	Time to HIV-1 RNA = 100 copies/ml		38 weeks