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.
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
OBSERVATIONAL
Enrollment
30
University of California, San Francisco HIV/AIDS CRS (801)
San Francisco, California, United States
RECRUITINGWashington University Therapeutics (WT) CRS (2101)
St Louis, Missouri, United States
RECRUITINGWeill Cornell Upton CRS (7803)
New York, New York, United States
Occurrence of an SAE or Grade ≥3 AE that is related to ATI
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.
Time frame: From study entry to 96 weeks
Change in CD4 percentage from parent study (pre-ATI) to Step 1 timepoints
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.
Time frame: From study entry to 96 weeks
Occurrence of new diagnoses of interest
Occurrence of new diagnoses of interest during Step 1 and Step 2.
Time frame: From study entry through 144 weeks
Time from ATI to sustained HIV-1 RNA ≥1000 copies/mL
Time from ATI to sustained HIV-1 RNA ≥1000 copies/mL over a 4-week period during Step 1.
Time frame: From study entry to 96 weeks
HIV RNA below 200 copies/mL
The proportion of participants with HIV RNA below 200 copies/mL at 8, 12, and 24 weeks after ART restart.
Time frame: 24 weeks after re-starting ART
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Case CRS (2501)
Cleveland, Ohio, United States
RECRUITINGChange in CD4% from pre-ATI to Step 2
Change in CD4% from pre-ATI (parent study) to Step 2 Week 12 and Step 2 Week 24 (after ART restart).
Time frame: From study entry to Step 2 week 24
Measurements of reservoir
Measurements of reservoir \[e.g., intact proviral DNA assay (IPDA)\] every 24 weeks during ATI, and 24 and 48 weeks after ART restart.
Time frame: From 24 weeks to 48 weeks after ART restart
Time from ATI to ART restart due to a viral, immune, or clinical reason
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).
Time frame: From study entry to 96 weeks
Time from ATI to ART restart
Time from ATI to ART restart, for any reason.
Time frame: From study entry to 96 weeks
Measurement of circulating reservoir
Cell-associated HIV-1 DNA and HIV-1 RNA measured in CD4+ T cells.
Time frame: 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
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.
Time frame: From study entry to 144 weeks
Measurement of replication-competent virus
Replication-competent virus, measured by the QVOA assay (or appropriate reservoir assay at time of testing).
Time frame: Every 24 weeks in Step 1 (up to 96 weeks) and Step 2 Week 24 and 48