Analytic Treatment Interruption (ATI) to Assess HIV Cure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2035-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Post Analytic Treatment Interruption Study

NCT02761200

HIV

RECRUITING

Analytical Treatment Interruption in HIV Positive Patients

NCT02590354

HIV-1 Infection

COMPLETED NA

HIV Sequencing After Treatment Interruption to Identify the Clinically Relevant Anatomical Reservoir

NCT02641756

HIV

COMPLETED NA

VRC-HIVMAB060-00-AB (VRC01) in People With Chronic HIV Infection Undergoing Analytical Treatment Interruption

NCT02471326

HIV

COMPLETED PHASE1

Viral Suppression After Analytic Treatment Interruption in Thai Patients Who Initiated Highly Active Antiretroviral Therapy During Acute HIV Infection

NCT02614950

Acute HIV Infection Antiretroviral Treatment Interruption

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment interruption

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

Group Type EXPERIMENTAL

Analytic treatment interruption

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Analytic treatment interruption

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No