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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if some people with HIV might be cured. To test this, participants will stop taking their antiretroviral medications under strict medical supervision to observe if the virus returns. This process, known as analytic treatment interruption (ATI), is specifically for those who have had no detectable HIV in their blood for at least six months while on treatment. Participants must be willing to stop treatment temporarily and use protection if sexually active. This offers a chance for those who might have cleared the virus to see if they can live without daily medication. As an unphased trial, this study provides a unique opportunity for participants to contribute to groundbreaking research that could redefine HIV treatment.

Will I have to stop taking my current medications?

Yes, you will need to stop taking your antiretroviral therapy for this trial, but it will be done under close medical supervision. The protocol does not specify about other medications, so it's best to discuss with the study team.

What prior data suggests that this protocol is safe for patients with HIV?

Research has shown that stopping HIV treatment, known as analytic treatment interruption (ATI), carries certain risks. When individuals discontinue their HIV medication, the virus can return rapidly, typically within two to three weeks. This can also heighten the risk of acquiring other infections or illnesses.

Researchers use ATI to gain insights into curing HIV. Although it yields valuable information, it necessitates careful monitoring. Doctors closely observe study participants to manage risks and promptly address any health issues.

Overall, while ATI serves as an important research tool, it involves potential risks that require careful management. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for HIV, which typically involves continuous antiretroviral therapy (ART) to suppress the virus, analytic treatment interruption (ATI) is unique because it involves temporarily stopping ART under close medical supervision. This approach allows researchers to study how the immune system responds without medication and could reveal whether the body can control the virus on its own. Researchers are excited about ATI because it might lead to insights for achieving a functional cure, reducing the need for lifelong medication.

What evidence suggests that analytic treatment interruption is effective for determining HIV cure?

Research has shown that when people stop taking antiretroviral therapy (ART) in a planned break called an analytic treatment interruption (ATI), their HIV levels usually increase quickly. In this trial, participants will undergo a treatment interruption under close laboratory monitoring and clinical supervision. One study found that the virus often becomes detectable again in about 16 to 21 days after stopping ART. However, many people can lower their virus levels again once they restart ART, especially with certain drug combinations. While ATI helps researchers learn how the virus acts without treatment, it's important to watch closely for any signs of the infection returning. These breaks are mainly used to explore possible HIV cures and are carefully monitored to manage risks. ^{1 4 5 6 7}

Who Is on the Research Team?

Andrew Badley, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8251690/

Analytical Treatment Interruption in HIV Trials SMART results showed that participants with prolonged treatment interruption had significantly increased risk of opportunistic disease, ...

2. nature.com nature.com/articles/s41467-025-56116-1

Time to HIV viral rebound and frequency of post-treatment ... The median time to pVL >50 copies/mL after ART interruption was 16 days (IQR: 13–25), while time to pVL >400 and >10,000 copies/mL was 21 (IQR: ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39155436/

a systematic review and meta-analysis - PubMed - NIH Conclusions: The majority of participants achieved viral suppression after restarting ART in ATI studies. ART regimens containing integrase inhibitors and ...

4. academic.oup.com academic.oup.com/jid/article/231/2/e419/7887579

Early Viral Dynamics Predict Human Immunodeficiency Virus ... We developed a predictive model of HIV posttreatment control after ATI using published viral kinetics data.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2055664024000232

Updated toolkit to mitigate HIV transmission risk Analytical treatment interruptions (ATIs) are widely used to evaluate HIV cure-related research interventions. However, sex partners of cure-related trial ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2352301824001577

Analytical treatment interruption in children living with HIV Analytical treatment interruption (ATI) is widely acknowledged as an essential component of studies to advance our understanding of HIV cure.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11330850/

The impact of analytical treatment interruptions and trial ... In this systematic review and meta‐analysis, we analysed recent studies to determine the proportion of people living with HIV participating in ATI cure‐related ...