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Enrolling by invitation NCT02437526

Analytic Treatment Interruption (ATI) to Assess HIV Cure

No phase Interventional HIV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Analytic treatment interruption.
Who it may be relevant to
Registry conditions: HIV. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Analytic Treatment Interruption of Antiretroviral Therapy to Assess for HIV Cure

Overview

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.

Interventions

  • Other Analytic treatment interruption

Primary outcome measures

  • Time to virologic rebound [Time frame: 38 weeks]
Secondary outcome measures (2)
  • Time to HIV-1 RNA ≥ 20 copies/ml [Time frame: 38 weeks]
  • Time to HIV-1 RNA ≥ 100 copies/ml [Time frame: 38 weeks]

Eligibility criteria

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 β-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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT02437526 · 15-001678

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗