Observational PIC Destination Cohort

December 10, 2024 updated by: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

An Observational Post-Intervention Control Destination Cohort

This study is being done to see if people who control HIV without antiretroviral therapy (ART) after receiving an intervention can remain off ART safely. The information collected in this study is also being used to try to understand how people control HIV without ART after receiving an intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This study is a two-step non-interventional study for participants who achieved prolonged viral control off ART, post-intervention (post-intervention control [PIC]) in qualifying AIDS Clinical Trials Group (ACTG) and non-ACTG interventional cure trials (parent studies).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • Recruiting
        • University of California, San Francisco HIV/AIDS CRS (801)
        • Contact:
        • Contact:
          • Annie Luetkemeyer, MD
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University Therapeutics (WT) CRS (2101)
        • Contact:
        • Contact:
          • Rachel Presti, MD, PhD
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Upton CRS (7803)
        • Contact:
        • Contact:
          • Phone Number: 212-746-7864
        • Contact:
          • Marshall J. Glesby, MD
    • Ohio
      • Cleveland, Ohio, United States, 44106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants who achieved prolonged viral control off ART post-intervention (post-intervention control [PIC]) in qualifying ACTG and non-ACTG interventional cure trials (parent studies).

Description

Step 1 Inclusion Criteria:

  • Currently or previously enrolled in a qualifying ACTG or non- ACTG parent study of curative or suppressive HIV therapy that included an ATI.
  • If feasible, participants should not remain co-enrolled in their respective parent study after entering A5385.
  • Achieved at least 24 weeks of HIV virus suppression (as defined by the parent study) following ATI initiation, remains off ART with <4 consecutive weeks of HIV-1 RNA >1000 copies/mL, CD4+ T-cell count > 350 cells/mm3 and not experiencing symptoms of acute retroviral syndrome.

NOTE: Participants whose participation has ended on the parent study may still qualify if they have not resumed ART, meet A5385's eligibility criteria, and have not met A5385 ART restart criteria.

  • CD4+ T cell count >350 cells/mm3 obtained within 28 days prior to study entry at any US laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent, or at any network-approved non-US laboratory that is IQA certified.
  • Willingness to continue ATI for up to 96 weeks or until ART restart criteria are met, and to remain in follow up for 48 weeks after ART restart.
  • For participants who are able to become pregnant, negative serum or urine pregnancy test within 24 hours prior to study entry by any US clinic or laboratory that has a CLIA certification or its equivalent, or is using a point of care (POC)/CLIA-waived test, or at any network-approved non-US laboratory or clinic that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance programs.

NOTE A: Participants who are able to become pregnant are individuals who have not been post-menopausal for at least 24 consecutive months, who have had menses within the preceding 24 months, and who have not undergone surgical sterilization, specifically hysterectomy and/or bilateral oophorectomy, tubal ligation, or bilateral salpingectomy.

NOTE B: Acceptable documentation of hysterectomy and bilateral oophorectomy, tubal ligation, and tubal micro-inserts: written documentation or oral communication from a clinician or clinician's staff documented in source documents (physician report/letter, operative report or other source documentation in the patient record, discharge summary, laboratory report, etc.). Participant-reported history is acceptable for documentation of menopause.

  • Participants who are able to become pregnant and are engaging in sexual activity that could lead to pregnancy must agree to use one highly effective method of contraception throughout the course of the study from the list below.

Acceptable methods of contraception include:

  • Barrier method
  • Contraceptive subdermal implant
  • Intrauterine device or intrauterine system
  • Combined estrogen and progestogen oral contraceptive
  • Injectable progestogen
  • Contraceptive vaginal ring
  • Percutaneous contraceptive patches

  • Male partner sterilization with documentation of azoospermia prior to the female participant's entry into the study, and this male is the sole partner for that participant.

    • Willingness to use barrier protection (male or female) during sexual activity with all partners not on effective pre-exposure prophylaxis (PrEP) throughout Step 1 ATI and until viral re-suppression in Step 2.

NOTE: Effective PrEP includes ART treatment for partners living with HIV infection.

  • Ability and willingness of participant to provide informed consent.

Step 2 Inclusion Criteria:

  • Met A5385 ART restart criteria in Step 1.
  • Willingness to use barrier protection (male or female) during sexual activity with all partners not on effective PrEP until viral re-suppression.

NOTE: Effective PrEP includes ART treatment for partners living with HIV infection.

Step 1 Exclusion Criteria:

  • Intercurrent illness, new medical diagnosis, laboratory abnormality, sign, or symptom that, in the opinion of the site investigator, would place participant at higher risk of morbidity during continued ATI.
  • Medical or psychiatric condition (including pregnancy or breastfeeding) that, in the opinion of the site investigator, would place the participant at higher risk of morbidity or would interfere with adherence to study requirements.

NOTE: Site investigators should exercise caution in invoking these criteria and instead aim to support potential participants who are interested and otherwise eligible to participate in the study.

Step 2 Exclusion Criteria:

  • Medical or psychiatric condition that, in the opinion of the site investigator, would place the participant at higher risk of morbidity or would interfere with adherence to study requirements.

NOTE: Site investigators should exercise caution in invoking these criteria and instead aim to support potential participants who are interested and otherwise eligible to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Observational PIC Destination Cohort

Step 1: Continued analytical treatment interruption (ATI) - During Step 1, PICs will be monitored for safety (including liver function, creatinine, pregnancy, and STI testing), viral, immune, neuropsychological, and socio-behavioral outcomes for up to 96 weeks of continued ATI.

Step 2: ART Restart - Participants will begin Step 2 if they meet ART restart criteria or reach week 96. Participants will be monitored for safety (including liver function, creatinine, and pregnancy), immune, viral, neuropsychological, and socio-behavioral outcomes through 48 weeks after ART restart.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Occurrence of an SAE or Grade ≥3 AE that is related to ATI
Time Frame: From study entry to 96 weeks

The proportion of participants reporting a serious adverse event (SAE) or a grade ≥ 3 adverse event (AE) that was judged by the A5385 clinical management committee to be at least possibly related to ATI during Step 1.

An AE is any unfavorable and unintended sign, symptom, or diagnosis occurring in a study participant during the conduct of the study regardless of the attribution. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation or existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the patient or require intervention to prevent one of the outcomes listed above.

Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death.
From study entry to 96 weeks
Change in CD4 percentage from parent study (pre-ATI) to Step 1 timepoints
Time Frame: From study entry to 96 weeks
Changes in CD4 percentage (CD4%) are calculated as the CD4% at the specified Step 1 timepoint minus the CD4% measured at the pre-ATI timepoint in the qualifying parent study.
From study entry to 96 weeks
Occurrence of new diagnoses of interest
Time Frame: From study entry through 144 weeks
Occurrence of new diagnoses of interest during Step 1 and Step 2.
From study entry through 144 weeks
Time from ATI to sustained HIV-1 RNA ≥1000 copies/mL
Time Frame: From study entry to 96 weeks
Time from ATI to sustained HIV-1 RNA ≥1000 copies/mL over a 4-week period during Step 1.
From study entry to 96 weeks
HIV RNA below 200 copies/mL
Time Frame: 24 weeks after re-starting ART
The proportion of participants with HIV RNA below 200 copies/mL at 8, 12, and 24 weeks after ART restart.
24 weeks after re-starting ART
Change in CD4% from pre-ATI to Step 2
Time Frame: From study entry to Step 2 week 24
Change in CD4% from pre-ATI (parent study) to Step 2 Week 12 and Step 2 Week 24 (after ART restart).
From study entry to Step 2 week 24
Measurements of reservoir
Time Frame: From 24 weeks to 48 weeks after ART restart
Measurements of reservoir [e.g., intact proviral DNA assay (IPDA)] every 24 weeks during ATI, and 24 and 48 weeks after ART restart.
From 24 weeks to 48 weeks after ART restart

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time from ATI to ART restart due to a viral, immune, or clinical reason
Time Frame: From study entry to 96 weeks
Time from ATI to ART restart due to a viral reason (plasma HIV-1 RNA ≥1000 copies/mL for ≥4 consecutive weeks without at least a 0.2 log10 decline from the previous week), and immune reason (confirmed CD4+ T cell count <350), or a clinical reason (e.g., acute retroviral syndrome).
From study entry to 96 weeks
Time from ATI to ART restart
Time Frame: From study entry to 96 weeks
Time from ATI to ART restart, for any reason.
From study entry to 96 weeks
Measurement of circulating reservoir
Time Frame: Every 24 weeks in Step 1 (up to 96 weeks) and Step 2 Week 24 and 48
Cell-associated HIV-1 DNA and HIV-1 RNA measured in CD4+ T cells.
Every 24 weeks in Step 1 (up to 96 weeks) and Step 2 Week 24 and 48
Plasma HIV-1 RNA at each study visit
Time Frame: From study entry to 144 weeks
Plasma HIV-1 RNA (copies/mL) at each study visit measured by clinical assay, or if unquantifiable by standard clinical assay (e.g., below the limit of quantification), single copy assay.
From study entry to 144 weeks
Measurement of replication-competent virus
Time Frame: Every 24 weeks in Step 1 (up to 96 weeks) and Step 2 Week 24 and 48
Replication-competent virus, measured by the QVOA assay (or appropriate reservoir assay at time of testing).
Every 24 weeks in Step 1 (up to 96 weeks) and Step 2 Week 24 and 48

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Association of viral or host characteristics with time to ART restart
Time Frame: From study entry to 96 weeks
Viral or host characteristics, including, but not limited to, laboratory measures (e.g., viral, inflammatory, reservoir, immune measures), host genetics (e.g., CCR5 heterogeneity, HLA type), or host demographics (e.g., gender, biologic sex, age) for association with time to meeting HIV-1 related, or any, ART restart criteria.
From study entry to 96 weeks
Virus properties and immune responses surrounding time of viral rebound
Time Frame: From study entry to 96 weeks
Properties of rebound virus, including genotype and phenotype by relevant assays, and immune response surrounding time of viral rebound.
From study entry to 96 weeks
Biomarkers of systemic inflammation and immune activation
Time Frame: From 24 weeks to 48 weeks after ART restart
Measurements of plasma soluble biomarkers of systemic inflammation and immune activation every 24 weeks during ATI and at 24 and 48 weeks after ART restart.
From 24 weeks to 48 weeks after ART restart
Anti-HIV cellular humoral and innate responses
Time Frame: From 24 weeks to 48 weeks after ART restart
Anti-HIV cellular humoral and innate responses every 24 weeks during ATI and at 24 and 48 weeks after ART restart.
From 24 weeks to 48 weeks after ART restart

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Katharine Bar, MD, Penn Therapeutics Clinical Research Site

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 19, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 3, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 3, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ACTG A5385
  • UM1AI068636 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie results in the publication, after deidentification.

IPD Sharing Time Frame

Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH.

IPD Sharing Access Criteria

  • With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group.
  • For what types of analyses? To achieve aims in the proposal approved by the AIDS Clinical Trials Group.
  • By what mechanism will data be made available? Researchers may submit a request for access to data using the AIDS Clinical Trials Group "Data Request" form at: https://actgnetwork.org/about-actg/templates-and-forms. Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Acknowledgement before receiving the data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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