- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001137
Long-Term Data Collection From Participants in Adult AIDS Clinical Trials
Adult AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT) Protocol
Study Overview
Status
Conditions
Detailed Description
A compilation of outcomes of various antiretroviral therapies would be beneficial when evaluating which strategies are most effective in long-term treatment of HIV-1. Using data from present and recently completed studies, this study will collect information on therapies and their control of HIV infection and maintenance of durable suppression of HIV-1 replication.
No treatment is provided by this study, but patients will continue to receive highly active antiretroviral therapy (HAART) from other studies in which they are coenrolled. Blood and urine collection will occur at study entry and periodically throughout the study. Women may undergo pelvic exams and Pap smears. Portions of blood samples will be stored to evaluate genotypic/phenotypic susceptibility testing. Medical histories, physical exams, and questionnaires will be completed periodically.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
San Juan, Puerto Rico, 009365067
- Univ of Puerto Rico
-
San Juan,, Puerto Rico, 00935
- Puerto Rico-AIDS CRS
-
-
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- Univ of Alabama at Birmingham
-
-
California
-
Los Angeles, California, United States, 90095
- UCLA CARE Ctr
-
Los Angeles, California, United States, 900331079
- Univ of Southern California / LA County USC Med Ctr
-
Los Angeles, California, United States, 90027
- Kaiser Permanente LAMC
-
Menlo Park, California, United States, 94025
- Willow Clinic
-
Sacramento, California, United States, 95814
- UC Davis Med Ctr
-
San Diego, California, United States, 921036325
- Univ of California / San Diego Treatment Ctr
-
San Francisco, California, United States, 94110
- Univ of California, San Francisco/San Francisco General Hosp
-
San Jose, California, United States, 951282699
- Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
-
San Rafael, California, United States, 94903
- Marin County Specialty Clinic
-
Stanford, California, United States, 943055107
- San Mateo AIDS Program / Stanford Univ
-
Stanford, California, United States, 943055107
- Stanford Univ Med Ctr
-
Torrance, California, United States, 90502
- Harbor UCLA Med Ctr
-
-
Colorado
-
Denver, Colorado, United States, 80262
- Univ of Colorado Health Sciences Ctr
-
Denver, Colorado, United States, 80204
- Denver Public Health CRS
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20007
- Georgetown Univ Med Ctr
-
-
Florida
-
Miami, Florida, United States, 331361013
- Univ of Miami School of Medicine
-
-
Georgia
-
Atlanta, Georgia, United States, 30308
- Emory Univ
-
Atlanta, Georgia, United States, 303652225
- Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
-
-
Hawaii
-
Honolulu, Hawaii, United States, 96816
- Univ of Hawaii
-
Tripler AMC, Hawaii, United States, 96859
- Tripler Army Med Ctr
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern Univ Med School
-
Chicago, Illinois, United States, 60612
- Rush Presbyterian - Saint Luke's Med Ctr
-
Chicago, Illinois, United States, 60612
- Cook County Hosp
-
-
Indiana
-
Indianapolis, Indiana, United States, 462025250
- Indiana Univ Hosp
-
Indianapolis, Indiana, United States, 46202
- Methodist Hosp of Indiana / Life Care Clinic
-
Indianapolis, Indiana, United States, 46202
- Division of Inf Diseases/ Indiana Univ Hosp
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- Univ of Iowa Hosp and Clinic
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70112
- Tulane Med Ctr Hosp
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins Hosp
-
Baltimore, Maryland, United States, 21201
- IHV Baltimore Treatment CRS
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Harvard (Massachusetts Gen Hosp)
-
Boston, Massachusetts, United States, 02118
- Boston Med Ctr
-
Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess - West Campus
-
Boston, Massachusetts, United States, 02115
- Brigham and Women's Hosp
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Wayne State Univ. CRS
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- Univ of Minnesota
-
Minneapolis, Minnesota, United States, 55415
- Hennepin County Medical Clinic
-
-
Missouri
-
St Louis, Missouri, United States, 63112
- St Louis Regional Hosp / St Louis Regional Med Ctr
-
-
Nebraska
-
Omaha, Nebraska, United States, 681985130
- Univ of Nebraska Med Ctr
-
-
New Jersey
-
Camden, New Jersey, United States, 08103
- Cooper Univ. Hosp. CRS
-
Newark, New Jersey, United States, 07103
- New Jersey Medical School- Adult Clinical Research Ctr. CRS
-
-
New York
-
Bronx, New York, United States, 10457
- Bronx-Lebanon Hosp. Ctr. CRS
-
Buffalo, New York, United States, 14215
- SUNY / Erie County Med Ctr at Buffalo
-
New York, New York, United States, 10003
- Beth Israel Med Ctr
-
New York, New York, United States, 10021
- Cornell Univ Med Ctr
-
New York, New York, United States, 10016
- Bellevue Hosp / New York Univ Med Ctr
-
New York, New York, United States, 10029
- Mount Sinai Med Ctr
-
New York, New York, United States, 10016
- NY Univ. HIV/AIDS CRS
-
New York, New York, United States, 10021
- Chelsea Ctr
-
New York, New York, United States, 10032
- Columbia Presbyterian Med Ctr
-
New York, New York, United States, 10021
- Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
-
Rochester, New York, United States, 14642
- Univ of Rochester Medical Center
-
Rochester, New York, United States, 14642
- Community Health Network Inc
-
Rochester,, New York, United States, 14607
- AIDS Care CRS
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 275997215
- Univ of North Carolina
-
Chapel Hill, North Carolina, United States, 27514
- Wake County Department of Health
-
Charlotte, North Carolina, United States, 28203
- Carolinas Med Ctr
-
Durham, North Carolina, United States, 27710
- Duke Univ Med Ctr
-
Greensboro, North Carolina, United States, 27401
- Moses H Cone Memorial Hosp
-
-
Ohio
-
Cincinnati, Ohio, United States, 452670405
- Univ of Cincinnati
-
Cleveland, Ohio, United States, 441091998
- MetroHealth Med Ctr
-
Cleveland, Ohio, United States, 44106-5083
- Cleveland Clinic
-
Columbus, Ohio, United States, 432101228
- Ohio State Univ Hosp Clinic
-
-
Oregon
-
Portland, Oregon, United States, 97210
- The Research & Education Group-Portland CRS
-
-
Pennsylvania
-
Norristown, Pennsylvania, United States, 19401
- Presbyterian Medical Center - Univ. of PA
-
Philadelphia, Pennsylvania, United States, 19104
- Univ of Pennsylvania at Philadelphia
-
Pittsburgh, Pennsylvania, United States, 15213
- Univ of Pittsburgh
-
-
South Carolina
-
West Columbia, South Carolina, United States, 29169
- Julio Arroyo
-
-
Tennessee
-
Nashville, Tennessee, United States, 37203
- Vanderbilt Univ Med Ctr
-
-
Texas
-
Dallas, Texas, United States, 75390
- Univ of Texas, Southwestern Med Ctr of Dallas
-
Dallas, Texas, United States, 75215
- Peabody Health Center CRS
-
Houston, Texas, United States, 77030
- Houston AIDS Research Team CRS
-
-
Virginia
-
Richmond, Virginia, United States, 23219
- Virginia Commonwealth Univ. Medical Ctr. CRS
-
-
Washington
-
Seattle, Washington, United States, 98104
- Univ of Washington
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria
- 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
Exclusion Criteria
- Active alcohol or drug abuse that may interfere with the study
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Successive suppressed viral load measures
Time Frame: Measured 144 weeks after randomization
|
Measured 144 weeks after randomization
|
Genotypic or phenotypic resistance
Time Frame: Measured at baseline and study completion
|
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
Time Frame: Measured throughout
|
Measured throughout
|
Absolute number and percentage of CD4 and CD8 T cells
Time Frame: Measured 144 weeks after randomization
|
Measured 144 weeks after randomization
|
Absolute number and percentage of naive cells, including CD4, CD45RA, and CD62L cells
Time Frame: Measured 144 weeks after randomization
|
Measured 144 weeks after randomization
|
Absolute number and percentage of memory cells, including CD4, CD45RO+, and CD45RA- cells
Time Frame: Measured 144 weeks after randomization
|
Measured 144 weeks after randomization
|
Levels of immune activation markers, including CD8, CD38, and HLA-DR cells
Time Frame: Measured 144 weeks after randomization
|
Measured 144 weeks after randomization
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HIV-1 latency or replication in tissue or cellular reservoirs
Time Frame: Measured at baseline, Week 16, Week 48, and study completion
|
Measured at baseline, Week 16, Week 48, and study completion
|
Syncytium and non-syncytium inducing (SI/NSI) phenotype
Time Frame: Measured at baseline, Week 16, Week 48, and study completion
|
Measured at baseline, Week 16, Week 48, and study completion
|
Metabolic and neurologic complications
Time Frame: Measured at baseline, Week 16, Week 48, and study completion
|
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
Time Frame: Measured 144 weeks after randomization
|
Measured 144 weeks after randomization
|
Plasma concentrations of antiretroviral medications other than nucleoside/tide reverse transcriptase inhibitors (NRTIs)
Time Frame: Measured at baseline, Week 16, and study completion
|
Measured at baseline, Week 16, and study completion
|
Effect of gender, use of hormonal therapies, presence or absence of menopause on short- and long-term virologic suppression, and pap smear abnormalities
Time Frame: Measured at baseline, Week 48, and study completion
|
Measured at baseline, Week 48, and study completion
|
Quality of life scores
Time Frame: Measured at baseline, Week 48, and study completion
|
Measured at baseline, Week 48, and study completion
|
Subject-reported patterns of adherence
Time Frame: Measured at baseline, Week 48, and study completion
|
Measured at baseline, Week 48, and study completion
|
Estimated inpatient, outpatient, and total costs
Time Frame: Measured at study completion
|
Measured at study completion
|
Collaborators and Investigators
Sponsor
Investigators
- 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
Publications and helpful links
General Publications
- Lok 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.
- 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.
- Torre 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.
- Siddiqui 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.
- Angelidou 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.
- Coban 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.
- Riddler 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.
- Lee 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.
- Besson 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.
- Tenorio 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.
- Cillo 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.
- Atkinson 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.
- Lok 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACTG A5001
- 1U01AI068636 (U.S. NIH Grant/Contract)
- AACTG A5001
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.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed