Long-Term Data Collection From Participants in Adult AIDS Clinical Trials
Adult AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT) Protocol
3 other identifiers
observational
5,982
2 countries
77
Brief Summary
The purpose of this study is to determine what combinations of anti-HIV drugs work best in patients treated over several years. The study will also assess the occurrence of side effects and opportunistic infections in patients with low viral loads compared to those with higher viral loads.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2000
Longer than P75 for all trials
77 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2000
CompletedFirst Submitted
Initial submission to the registry
January 28, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedDecember 6, 2013
December 1, 2013
13.8 years
January 28, 2000
December 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Successive suppressed viral load measures
Measured 144 weeks after randomization
Genotypic or phenotypic resistance
Measured at baseline and study completion
Complications of HIV disease, including survival, HIV-related opportunistic infections, HIV-related non-opportunistic complications, adverse effects of antiretroviral therapies of grade three or greater
Measured throughout
Absolute number and percentage of CD4 and CD8 T cells
Measured 144 weeks after randomization
Absolute number and percentage of naive cells, including CD4, CD45RA, and CD62L cells
Measured 144 weeks after randomization
Absolute number and percentage of memory cells, including CD4, CD45RO+, and CD45RA- cells
Measured 144 weeks after randomization
Levels of immune activation markers, including CD8, CD38, and HLA-DR cells
Measured 144 weeks after randomization
Secondary Outcomes (9)
HIV-1 latency or replication in tissue or cellular reservoirs
Measured at baseline, Week 16, Week 48, and study completion
Syncytium and non-syncytium inducing (SI/NSI) phenotype
Measured at baseline, Week 16, Week 48, and study completion
Metabolic and neurologic complications
Measured at baseline, Week 16, Week 48, and study completion
Immune responses to antigens such as cytomegalovirus (CMV), Myobacterium avium complex (MAC), Candida, and HIV
Measured 144 weeks after randomization
Plasma concentrations of antiretroviral medications other than nucleoside/tide reverse transcriptase inhibitors (NRTIs)
Measured at baseline, Week 16, and study completion
- +4 more secondary outcomes
Eligibility Criteria
Participants in this study will be HIV-infected men and women who are enrolled in an ACTG parent study and are receiving HAART.
You may qualify if:
- HIV-1 infected
- Enrolled in an AIDS Clinical Trial Group (ACTG) parent study and has enrolled in this study on or before the Week 16 visit of the parent study, including the visit window of the parent study. More information on this criterion can be found in the protocol.
- Willing to provide consent for the release and use of clinical data from the parent study
- Life expectancy of at least 24 weeks
- Parent or guardian willing to provide informed consent, if applicable
You may not qualify if:
- Active alcohol or drug abuse that may interfere with the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (77)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Kaiser Permanente LAMC
Los Angeles, California, 90027, United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079, United States
UCLA CARE Ctr
Los Angeles, California, 90095, United States
Willow Clinic
Menlo Park, California, 94025, United States
UC Davis Med Ctr
Sacramento, California, 95814, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325, United States
Univ of California, San Francisco/San Francisco General Hosp
San Francisco, California, 94110, United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699, United States
Marin County Specialty Clinic
San Rafael, California, 94903, United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107, United States
Stanford Univ Med Ctr
Stanford, California, 943055107, United States
Harbor UCLA Med Ctr
Torrance, California, 90502, United States
Denver Public Health CRS
Denver, Colorado, 80204, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007, United States
Univ of Miami School of Medicine
Miami, Florida, 331361013, United States
Emory Univ
Atlanta, Georgia, 30308, United States
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
Atlanta, Georgia, 303652225, United States
Univ of Hawaii
Honolulu, Hawaii, 96816, United States
Tripler Army Med Ctr
Tripler AMC, Hawaii, 96859, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Cook County Hosp
Chicago, Illinois, 60612, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250, United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202, United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202, United States
Univ of Iowa Hosp and Clinic
Iowa City, Iowa, 52242, United States
Tulane Med Ctr Hosp
New Orleans, Louisiana, 70112, United States
IHV Baltimore Treatment CRS
Baltimore, Maryland, 21201, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114, United States
Brigham and Women's Hosp
Boston, Massachusetts, 02115, United States
Boston Med Ctr
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215, United States
Wayne State Univ. CRS
Detroit, Michigan, 48201, United States
Hennepin County Medical Clinic
Minneapolis, Minnesota, 55415, United States
Univ of Minnesota
Minneapolis, Minnesota, 55455, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, 63112, United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130, United States
Cooper Univ. Hosp. CRS
Camden, New Jersey, 08103, United States
New Jersey Medical School- Adult Clinical Research Ctr. CRS
Newark, New Jersey, 07103, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
NY Univ. HIV/AIDS CRS
New York, New York, 10016, United States
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
New York, New York, 10021, United States
Chelsea Ctr
New York, New York, 10021, United States
Cornell Univ Med Ctr
New York, New York, 10021, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
Columbia Presbyterian Med Ctr
New York, New York, 10032, United States
AIDS Care CRS
Rochester, New York, 14607, United States
Community Health Network Inc
Rochester, New York, 14642, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
Bronx-Lebanon Hosp. Ctr. CRS
The Bronx, New York, 10457, United States
Wake County Department of Health
Chapel Hill, North Carolina, 27514, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Carolinas Med Ctr
Charlotte, North Carolina, 28203, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Moses H Cone Memorial Hosp
Greensboro, North Carolina, 27401, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405, United States
Cleveland Clinic
Cleveland, Ohio, 44106-5083, United States
MetroHealth Med Ctr
Cleveland, Ohio, 441091998, United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228, United States
The Research & Education Group-Portland CRS
Portland, Oregon, 97210, United States
Presbyterian Medical Center - Univ. of PA
Norristown, Pennsylvania, 19401, United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Julio Arroyo
West Columbia, South Carolina, 29169, United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203, United States
Peabody Health Center CRS
Dallas, Texas, 75215, United States
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, 75390, United States
Houston AIDS Research Team CRS
Houston, Texas, 77030, United States
Virginia Commonwealth Univ. Medical Ctr. CRS
Richmond, Virginia, 23219, United States
Univ of Washington
Seattle, Washington, 98104, United States
Puerto Rico-AIDS CRS
San Juan, 00935, Puerto Rico
Univ of Puerto Rico
San Juan, 009365067, Puerto Rico
Related Publications (13)
Jain R, Clark NM, Diaz-Linares M, Grim SA. Limitations of current antiretroviral agents and opportunities for development. Curr Pharm Des. 2006;12(9):1065-74. doi: 10.2174/138161206776055813.
PMID: 16515486BACKGROUNDTorre D, Speranza F, Martegani R. Impact of highly active antiretroviral therapy on organ-specific manifestations of HIV-1 infection. HIV Med. 2005 Mar;6(2):66-78. doi: 10.1111/j.1468-1293.2005.00268.x.
PMID: 15807712BACKGROUNDSiddiqui M, Moore TJ, Long DM, Burkholder GA, Willig A, Wyatt C, Heath S, Muntner P, Overton ET. Risk Factors for Incident Hypertension Within 1 Year of Initiating Antiretroviral Therapy Among People with HIV. AIDS Res Hum Retroviruses. 2022 Sep;38(9):735-742. doi: 10.1089/AID.2021.0213. Epub 2022 Aug 23.
PMID: 35778856DERIVEDAngelidou K, Hunt PW, Landay AL, Wilson CC, Rodriguez B, Deeks SG, Bosch RJ, Lederman MM. Changes in Inflammation but Not in T-Cell Activation Precede Non-AIDS-Defining Events in a Case-Control Study of Patients on Long-term Antiretroviral Therapy. J Infect Dis. 2018 Jun 20;218(2):239-248. doi: 10.1093/infdis/jix666.
PMID: 29309629DERIVEDCoban H, Robertson K, Smurzynski M, Krishnan S, Wu K, Bosch RJ, Collier AC, Ellis RJ. Impact of aging on neurocognitive performance in previously antiretroviral-naive HIV-infected individuals on their first suppressive regimen. AIDS. 2017 Jul 17;31(11):1565-1571. doi: 10.1097/QAD.0000000000001523.
PMID: 28471765DERIVEDRiddler SA, Aga E, Bosch RJ, Bastow B, Bedison M, Vagratian D, Vaida F, Eron JJ, Gandhi RT, Mellors JW; ACTG A5276s Protocol Team. Continued Slow Decay of the Residual Plasma Viremia Level in HIV-1-Infected Adults Receiving Long-term Antiretroviral Therapy. J Infect Dis. 2016 Feb 15;213(4):556-60. doi: 10.1093/infdis/jiv433. Epub 2015 Sep 2.
PMID: 26333941DERIVEDLee AJ, Bosch RJ, Evans SR, Wu K, Harrison T, Grant P, Clifford DB. Patterns of peripheral neuropathy in ART-naive patients initiating modern ART regimen. J Neurovirol. 2015 Apr;21(2):210-8. doi: 10.1007/s13365-015-0327-1. Epub 2015 Feb 13.
PMID: 25678143DERIVEDBesson GJ, Lalama CM, Bosch RJ, Gandhi RT, Bedison MA, Aga E, Riddler SA, McMahon DK, Hong F, Mellors JW. HIV-1 DNA decay dynamics in blood during more than a decade of suppressive antiretroviral therapy. Clin Infect Dis. 2014 Nov 1;59(9):1312-21. doi: 10.1093/cid/ciu585. Epub 2014 Jul 29.
PMID: 25073894DERIVEDTenorio AR, Zheng Y, Bosch RJ, Krishnan S, Rodriguez B, Hunt PW, Plants J, Seth A, Wilson CC, Deeks SG, Lederman MM, Landay AL. Soluble markers of inflammation and coagulation but not T-cell activation predict non-AIDS-defining morbid events during suppressive antiretroviral treatment. J Infect Dis. 2014 Oct 15;210(8):1248-59. doi: 10.1093/infdis/jiu254. Epub 2014 May 1.
PMID: 24795473DERIVEDCillo AR, Krishnan S, McMahon DK, Mitsuyasu RT, Para MF, Mellors JW. Impact of chemotherapy for HIV-1 related lymphoma on residual viremia and cellular HIV-1 DNA in patients on suppressive antiretroviral therapy. PLoS One. 2014 Mar 17;9(3):e92118. doi: 10.1371/journal.pone.0092118. eCollection 2014.
PMID: 24638072DERIVEDLok JJ, Hunt PW, Collier AC, Benson CA, Witt MD, Luque AE, Deeks SG, Bosch RJ. The impact of age on the prognostic capacity of CD8+ T-cell activation during suppressive antiretroviral therapy. AIDS. 2013 Aug 24;27(13):2101-10. doi: 10.1097/QAD.0b013e32836191b1.
PMID: 24326304DERIVEDAtkinson BE, Krishnan S, Cox G, Hulgan T, Collier AC. Anthropometric differences between HIV-infected individuals prior to antiretroviral treatment and the general population from 1998-2007: the AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT) cohort and NHANES. PLoS One. 2013 Jun 3;8(6):e65306. doi: 10.1371/journal.pone.0065306. Print 2013.
PMID: 23755215DERIVEDLok JJ, Bosch RJ, Benson CA, Collier AC, Robbins GK, Shafer RW, Hughes MD; ALLRT team. Long-term increase in CD4+ T-cell counts during combination antiretroviral therapy for HIV-1 infection. AIDS. 2010 Jul 31;24(12):1867-76. doi: 10.1097/QAD.0b013e32833adbcf.
PMID: 20467286DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Constance A. Benson, MD
Division of Infectious Disease, Antiviral Research Center, University of California, San Diego
- STUDY CHAIR
Ann C. Collier, MD
University of Washington
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2000
First Posted
August 31, 2001
Study Start
January 1, 2000
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
December 6, 2013
Record last verified: 2013-12