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Part 1: Document Description
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Citation |
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Title: |
ACTG ART Interruption Studies: Viral Rebound after Treatment Interruption |
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Identification Number: |
doi:10.7910/DVN/FEGPUJ |
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Distributor: |
Harvard Dataverse |
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Date of Distribution: |
2026-01-22 |
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Version: |
1 |
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Bibliographic Citation: |
ACTG Statistical and Data Analysis Center, 2026, "ACTG ART Interruption Studies: Viral Rebound after Treatment Interruption", https://doi.org/10.7910/DVN/FEGPUJ, Harvard Dataverse, V1 |
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Citation |
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Title: |
ACTG ART Interruption Studies: Viral Rebound after Treatment Interruption |
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Subtitle: |
SAS transport files and associated documentation |
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Alternative Title: |
ACTG ART Interruption Studies: Viral Rebound after Treatment Interruption Final Analysis Datasets |
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Identification Number: |
doi:10.7910/DVN/FEGPUJ |
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Authoring Entity: |
ACTG Statistical and Data Analysis Center (Harvard University) |
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Grant Number: |
UM1 AI068634 |
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Grant Number: |
UM1 AI068636 |
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Grant Number: |
UM1 AI106701 |
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Distributor: |
Harvard Dataverse |
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Access Authority: |
Lemay, Celeste |
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Access Authority: |
ACTG Statistical and Data Analysis Center |
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Depositor: |
Highter, Melissa |
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Date of Deposit: |
2026-01-22 |
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Holdings Information: |
https://doi.org/10.7910/DVN/FEGPUJ |
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Study Scope |
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Keywords: |
Medicine, Health and Life Sciences, Analytic Treatment Interruption (ATI), Antiretroviral Treatment (ART), HIV |
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Abstract: |
These datasets contain data for the N = 235 participants from 6 ACTG studies with Analytic Treatment Interruption (ATI), who were on suppressive antiretroviral treatment (ART), received no immunologic interventions, and had HIV-1 RNA level < 50 copies/mL at time of ATI. As described in the primary paper (Li 2016), the 6 source studies are: ACTG 371, ACTG 5024, ACTG 5068, ACTG 5170, ACTG 5187, ACTG 5197. Note that HIV-1 RNA levels during ATI were measured less frequently in ACTG 5170 (every 4 weeks) than in the other studies. If ACTG 5170 is excluded, the remaining N = 139 participants were in studies where HIV-1 RNA levels were to be measured every 1-2 weeks initially during ATI.<br><br> N = 124 participants (of the 235) had HIV-persistence data measured prior to ART interruption. These data were examined in Li 2016 and also in multiple statistical methods and modeling papers (Conway 2019, Wang 2020, Lok 2021, Chernofsky 2024, Chernofsky 2025), including causal mediation analysis for the effects of pre-ATI HIV-persistence measures on ATI outcomes.<br><br> Note that currently conducted ATI studies typically do not include participants taking Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) (see Li et al. 2022), so for use of these data as historical controls for ATI outcomes, recommend exclude those taking NNRTIs at the time of ATI. |
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Kind of Data: |
Patient Level Data |
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Notes: |
USING THE SAS FILES: The SAS transport file (.trn) contains the datasets for this study. To use the unpacking program provided (unpack.sas), place the program and the SAS transport (.trn) file in the same directory, then run unpack.sas using SAS. The files will unpack into that directory. Please note that the unpacking program must be used because of the way SAS handles transferring datasets from one computer system to another. NOTES ABOUT THE DE-IDENTIFIED FILES: The data are de-identified so that no original identifiers are included in the data files. In order to de-identify data for public use, all dates (if included) have been converted to the number of days from a reference date. The SAS labels specify the start day for the calculation of the number of days in the variable. All site and institution information has been removed. Also, any other variable that has been deemed inappropriate to include in these public use datasets has been removed. This might limit how the files can be used. The de-identification process has been done in response to current regulatory requirements. RAW DATA FILES: The file Study_Data_CSV_ATI_LI_2016.zip contains comma separated value (.csv) files for this study. ADDITIONAL INFORMATION: Additional information concerning the data can be found in the file documentation files and metadata.csv. |
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Methodology and Processing |
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Sources Statement |
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Data Access |
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Notes: |
<a href="http://creativecommons.org/licenses/by-nc/4.0">CC BY-NC 4.0</a> |
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Other Study Description Materials |
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Related Publications |
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Citation |
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Title: |
Li JZ, Etemad B, Ahmed H, Aga E, Bosch RJ, Mellors JW, Kuritzkes DR, Lederman MM, Para M, Gandhi RT. The size of the expressed HIV reservoir predicts timing of viral rebound after treatment interruption. AIDS. 2016 Jan 28;30(3):343-53. doi: 10.1097/QAD.0000000000000953. Erratum in: AIDS. 2016 Sep 10;30(14):2259. doi: 10.1097/01.aids.0000499516.66930.89. PMID: 26588174; PMCID: PMC4840470. |
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Bibliographic Citation: |
Li JZ, Etemad B, Ahmed H, Aga E, Bosch RJ, Mellors JW, Kuritzkes DR, Lederman MM, Para M, Gandhi RT. The size of the expressed HIV reservoir predicts timing of viral rebound after treatment interruption. AIDS. 2016 Jan 28;30(3):343-53. doi: 10.1097/QAD.0000000000000953. Erratum in: AIDS. 2016 Sep 10;30(14):2259. doi: 10.1097/01.aids.0000499516.66930.89. PMID: 26588174; PMCID: PMC4840470. |
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Citation |
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Title: |
Conway JM, Perelson AS, Li JZ. Predictions of time to HIV viral rebound following ART suspension that incorporate personal biomarkers. PLoS Comput Biol. 2019 Jul 24;15(7):e1007229. doi: 10.1371/journal.pcbi.1007229. PMID: 31339888; PMCID: PMC6682162. |
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Bibliographic Citation: |
Conway JM, Perelson AS, Li JZ. Predictions of time to HIV viral rebound following ART suspension that incorporate personal biomarkers. PLoS Comput Biol. 2019 Jul 24;15(7):e1007229. doi: 10.1371/journal.pcbi.1007229. PMID: 31339888; PMCID: PMC6682162. |
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Citation |
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Title: |
Wang R, Bing A, Wang C, Hu Y, Bosch RJ, DeGruttola V. A flexible nonlinear mixed effects model for HIV viral load rebound after treatment interruption. Stat Med. 2020 Jul 10;39(15):2051-2066. doi: 10.1002/sim.8529. Epub 2020 Apr 15. PMID: 32293756; PMCID: PMC8081565. |
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Bibliographic Citation: |
Wang R, Bing A, Wang C, Hu Y, Bosch RJ, DeGruttola V. A flexible nonlinear mixed effects model for HIV viral load rebound after treatment interruption. Stat Med. 2020 Jul 10;39(15):2051-2066. doi: 10.1002/sim.8529. Epub 2020 Apr 15. PMID: 32293756; PMCID: PMC8081565. |
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Citation |
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Title: |
Lok JJ, Bosch RJ. Causal Organic Indirect and Direct Effects: Closer to the Original Approach to Mediation Analysis, with a Product Method for Binary Mediators. Epidemiology. 2021 May 1;32(3):412-420. doi: 10.1097/EDE.0000000000001339. PMID: 33783395; PMCID: PMC8362675. |
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Bibliographic Citation: |
Lok JJ, Bosch RJ. Causal Organic Indirect and Direct Effects: Closer to the Original Approach to Mediation Analysis, with a Product Method for Binary Mediators. Epidemiology. 2021 May 1;32(3):412-420. doi: 10.1097/EDE.0000000000001339. PMID: 33783395; PMCID: PMC8362675. |
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Citation |
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Title: |
Li JZ, Aga E, Bosch RJ, Pilkinton M, Kroon E, MacLaren L, Keefer M, Fox L, Barr L, Acosta E, Ananworanich J, Coombs R, Mellors JW, Landay AL, Macatangay B, Deeks S, Gandhi RT, Smith DM. Time to Viral Rebound After Interruption of Modern Antiretroviral Therapies. Clin Infect Dis. 2022 Mar 9;74(5):865-870. doi: 10.1093/cid/ciab541. PMID: 34117753; PMCID: PMC8906742. |
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Bibliographic Citation: |
Li JZ, Aga E, Bosch RJ, Pilkinton M, Kroon E, MacLaren L, Keefer M, Fox L, Barr L, Acosta E, Ananworanich J, Coombs R, Mellors JW, Landay AL, Macatangay B, Deeks S, Gandhi RT, Smith DM. Time to Viral Rebound After Interruption of Modern Antiretroviral Therapies. Clin Infect Dis. 2022 Mar 9;74(5):865-870. doi: 10.1093/cid/ciab541. PMID: 34117753; PMCID: PMC8906742. |
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Citation |
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Title: |
Chernofsky A, Bosch RJ, Lok JJ. Causal mediation analysis with mediator values below an assay limit. Stat Med. 2024 May 30;43(12):2299-2313. doi: 10.1002/sim.10065. Epub 2024 Mar 31. PMID: 38556761; PMCID: PMC11207996. |
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Bibliographic Citation: |
Chernofsky A, Bosch RJ, Lok JJ. Causal mediation analysis with mediator values below an assay limit. Stat Med. 2024 May 30;43(12):2299-2313. doi: 10.1002/sim.10065. Epub 2024 Mar 31. PMID: 38556761; PMCID: PMC11207996. |
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Citation |
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Title: |
Chernofsky A, Lok JJ. Causal mediation analysis for time-to-event outcomes on the Restricted Mean Survival Time scale: A pseudo-value approach. PLoS One. 2025 Apr 9;20(4):e0319074. doi: 10.1371/journal.pone.0319074. PMID: 40203275; PMCID: PMC11981657. |
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Bibliographic Citation: |
Chernofsky A, Lok JJ. Causal mediation analysis for time-to-event outcomes on the Restricted Mean Survival Time scale: A pseudo-value approach. PLoS One. 2025 Apr 9;20(4):e0319074. doi: 10.1371/journal.pone.0319074. PMID: 40203275; PMCID: PMC11981657. |
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Label: |
Documentation_Data_File_Readme.txt |
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Notes: |
text/plain |
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Label: |
Documentation_PUBLIC_USE_ATI_LI_2016_README.txt |
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Notes: |
text/plain |
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Label: |
SAS_ATI_LI_2016.trn |
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Notes: |
application/octet-stream |
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Label: |
SAS_Data_Output_ati_li_2016_demo_vir.contents.lst |
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Notes: |
application/octet-stream |
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Label: |
SAS_Data_Output_ati_li_2016_long_rna.contents.lst |
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Notes: |
application/octet-stream |
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Label: |
SAS_Data_Output_ATI_LI_2016.lst |
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Notes: |
application/octet-stream |
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Label: |
SAS_unpack.sas |
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Notes: |
text/x-sas-syntax |
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Label: |
Study_Data_CSV_ATI_LI_2016.zip |
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Notes: |
application/zip |