ATI for HIV Cure

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: Antiretrovirals

Disqualifiers: Pregnancy, Advanced cardiopulmonary, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

10 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Andrew Badley, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

Adults over 18 with HIV, potentially cured after routine care, are eligible. They must have undetectable HIV RNA and proviral DNA for at least 6 months on therapy. Participants should use barrier contraception or abstain from sex during the trial. Pregnant or nursing women and those not using contraceptives are excluded.

Inclusion Criteria

My HIV is undetectable and I've been on treatment for at least 6 months.

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

Able and willing to either abstain from sexual activity or use barrier contraceptives during the ATI

Exclusion Criteria

I am not pregnant or nursing.

I cannot or will not use birth control methods during the trial.

I am being treated for Hepatitis B to control the virus without affecting any HIV treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Interruption

Antiretroviral therapy is discontinued under close laboratory monitoring and clinical supervision

Duration not specified

Follow-up

Participants are monitored for reactivation of infection after treatment interruption

Duration not specified

Treatment Details

Interventions

• Analytic treatment interruption

Trial Overview The study tests if patients can be considered cured of HIV by stopping their antiretroviral therapy under medical supervision to see if the infection reactivates.

Participant Groups

Group I: Treatment interruption Experimental Treatment 1 Intervention

Antiretroviral therapy will be discontinued under close laboratory monitoring and clinical supervision.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+