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Observational Study for HIV-1-Infected Individuals

This study is for people living with HIV-1 who have previously participated in another study involving an analytical treatment interruption (ATI), where they stopped their antiretroviral therapy (ART) under medical supervision. The goal is to understand if you can safely remain off ART and how your body controls HIV without medication after such an intervention. Researchers will look for serious side effects or severe adverse events (SAEs or AEs) related to the ATI, changes in your CD4 percentage (a measure of immune health), and any new health diagnoses. This study is observational, meaning you won't receive new treatments, but researchers will collect information about your health. The study is currently unclear on its recruitment status and plans to enroll 30 participants.

Study design
This is an observational study with an unclear status, planning to enroll 30 participants. It is a two-step study for individuals who have achieved prolonged viral control off ART after a previous intervention.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for the occurrence of serious side effects or severe adverse events related to ATI for up to 96 weeks, changes in CD4 percentage for up to 96 weeks, and new diagnoses for up to 144 weeks.

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NCT05985642

Observational PIC Destination Cohort

Recruiting
Not specifiedAges 18+Observational
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
~30 participants
Updated 2024-12-13 on ClinicalTrials.gov

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of an SAE or Grade ≥3 AE that is related to ATI
Measured over From study entry to 96 weeks
+6 more outcomes measured

Conditions

HIV-1-infection

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Where it's being run

4 sites across 4 states
California1
Missouri1
New York1
Ohio1

Study leadership

  • Katharine Bar, MD · STUDY_CHAIR · Penn Therapeutics Clinical Research Site

Who to contact

ACTG ClinicalTrials.gov Coordinator
[email protected]
(301)628-3348
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Eligibility criteria

Inclusion

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.
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.
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.
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.
Ability and willingness of participant to provide informed consent.
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.

Exclusion

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.
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.

What this trial measures

  • Occurrence of an SAE or Grade ≥3 AE that is related to ATIFrom 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.

  • Change in CD4 percentage from parent study (pre-ATI) to Step 1 timepointsFrom 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.

  • Occurrence of new diagnoses of interestFrom study entry through 144 weeks

    Occurrence of new diagnoses of interest during Step 1 and Step 2.

  • Time from ATI to sustained HIV-1 RNA ≥1000 copies/mLFrom study entry to 96 weeks

    Time from ATI to sustained HIV-1 RNA ≥1000 copies/mL over a 4-week period during Step 1.

  • HIV RNA below 200 copies/mL24 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.

  • Change in CD4% from pre-ATI to Step 2From 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).

  • Measurements of reservoirFrom 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.