HIVNCT02437526
Analytic Treatment Interruption (ATI) to Assess HIV Cure
A study testing Analytic treatment interruption in people with HIV, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Analytic treatment interruption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to May 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Analytic Treatment Interruption of Antiretroviral Therapy to Assess for HIV Cure
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.
- Conditions
- HIV
- Being tested
- Analytic treatment interruption
- Keywords
- Cure, Analytic treatment interruption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analytic treatment interruptionOther
| Study group | Role | What they receive |
|---|---|---|
| Treatment interruption | Experimental | Antiretroviral therapy will be discontinued under close laboratory monitoring and clinical supervision. Receives: Other: Analytic treatment interruption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to virologic rebound
Measured: 38 weeks
Secondary outcomes (2)
Time to HIV-1 RNA ≥ 20 copies/ml
Measured: 38 weeks
Time to HIV-1 RNA ≥ 100 copies/ml
Measured: 38 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2035 (estimated)
- Study completionMay 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew D. Badley, M.D., Mayo Clinic
- Investigators
- Andrew Badley, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437526
- Sponsor's protocol ID
- 15-001678
- Status last verified
- Jun 2026
- First submitted
- 5 May 2015
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analytic Treatment Interruption of Antiretroviral Therapy to Assess for HIV Cure
- ClinicalTrials.gov ID
- NCT02437526
- Acronym / sponsor ID
- 15-001678
- Conditions
- HIV
- Keywords
- Cure, Analytic treatment interruption
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2035 (estimated)
- Study completion
- May 2035 (estimated)
- First posted
- 7 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment interruption | Experimental | Other: Analytic treatment interruptionAntiretroviral therapy will be discontinued under close laboratory monitoring and clinical supervision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analytic treatment interruption | Other | Treatment interruption |
Primary outcome
Time to virologic rebound
Time frame: 38 weeks
2 secondary outcomes
Time to HIV-1 RNA ≥ 20 copies/ml
Time frame: 38 weeks
Time to HIV-1 RNA ≥ 100 copies/ml
Time frame: 38 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Badley, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analytic treatment interruption in people with HIV, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to virologic rebound (time frame: 38 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.