Sponsor study identifier
Secondary identifiers
interventional
283
3 countries
45
Study Start
March 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2006
Actual (reported)Study Completion
August 2007
Actual (reported)The purpose of this study is to evaluate the effect of starting anti-HIV drugs in HIV infected patients who are being treated for opportunistic infections (OIs). This study will follow two patient groups: those who received anti-HIV drugs soon after being diagnosed with an OI and patients with OIs who deferred beginning anti-HIV drugs until after recovering from the OI.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2007
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 19, 2003
Actual (reported)February 20, 2003
Actual (reported)March 2003
Date type not reportedThis date has not been verified as actual or estimated.
September 2006
Actual (reported)August 2007
Actual (reported)Survival, recurrence of presenting OI/bacterial infection (BI) or incidence of new AIDS-defining events, and HIV-1 plasma viral load at Week 48
HIV-1 plasma viral load at all timepoints up to and including Week 48
CD4 counts at all timepoints up to and including Week 48
changes in ARV regimen for lack of efficacy
efficacy of treatment and clinical outcomes for specific OI/BI, including duration of and complications of treatment, incidence and duration of hospitalization, rate of relapse/recurrence, and incidence of IRIS and impact on outcomes in the two arms
safety and tolerability, measured by Grade 3 and 4 signs and symptoms and laboratory toxicities, ART and OI/BI treatment changes and dose modifications due to toxicities, and IRIS
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Emtricitabine/tenofovir disoproxil fumarate
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Lopinavir/ritonavir
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordUniversity of California, Davis Medical Center
Sacramento, California, 95814, United States
University of California, San Diego Antiviral Rese
San Diego, California, 92103, United States
San Francisco General Hospital
San Francisco, California, 94110, United States
San Mateo County AIDS Program
Stanford, California, 94305-5107, United States
Santa Clara Valley Medical Center
Stanford, California, 94305-5107, United States
Stanford Univ
Stanford, California, 94305-5107, United States
Willow Clinic
Wislez M, Bergot E, Antoine M, Parrot A, Carette MF, Mayaud C, Cadranel J. Acute respiratory failure following HAART introduction in patients treated for Pneumocystis carinii pneumonia. Am J Respir Crit Care Med. 2001 Sep 1;164(5):847-51. doi: 10.1164/ajrccm.164.5.2007034.
Bartlett JA, DeMasi R, Quinn J, Moxham C, Rousseau F. Overview of the effectiveness of triple combination therapy in antiretroviral-naive HIV-1 infected adults. AIDS. 2001 Jul 27;15(11):1369-77. doi: 10.1097/00002030-200107270-00006.
Andrew R. Zolopa, MD
Division of Infectious Diseases, Stanford University
283 participants (actual enrollment reported by the registry).
First Submitted
February 19, 2003
First Posted
February 20, 2003
Study Start
March 2003
Date type not reportedThis date has not been verified as actual or estimated.
A Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Stanford, California, 94305-5107, United States
Harbor General/UCLA
Torrance, California, 90502-2052, United States
University of Colorado Health Sciences Center, Denver
Denver, Colorado, 80262-3706, United States
Univ of Miami
Miami, Florida, 33136-1013, United States
Emory University
Atlanta, Georgia, 30308, United States
Northwestern University
Chicago, Illinois, 60611-3015, United States
Cook County Hospital Core Center
Chicago, Illinois, 60612, United States
Methodist Hospital of Indiana
Indianapolis, Indiana, 46202-1261, United States
Indiana University Hosp
Indianapolis, Indiana, 46202-5250, United States
Wishard Hospital
Indianapolis, Indiana, 46202, United States
University of Maryland, Institute of Human Virology
Baltimore, Maryland, 21201, United States
Johns Hopkins University
Baltimore, Maryland, 21287-8106, United States
Harvard (Massachusetts General Hospital)
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215, United States
Brigham and Womens Hospital
Boston, Massachusetts, 02215, United States
Hennepin County Medical Clinic
Minneapolis, Minnesota, 55455-0392, United States
St. Louis Connect Care
St Louis, Missouri, 63108-2138, United States
Washington University (St. Louis)
St Louis, Missouri, 63108-2138, United States
Beth Israel Medical Center
New York, New York, 10003, United States
NYU/Bellevue
New York, New York, 10016-6481, United States
Columbia University
New York, New York, 10021, United States
Community Health Network, Inc.
Rochester, New York, 14642-0001, United States
University of Rochester Medical Center
Rochester, New York, 14642-0001, United States
University of North Carolina
Chapel Hill, North Carolina, 27514, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University of Cincinnati
Cincinnati, Ohio, 45267-0405, United States
Case Western Reserve University
Cleveland, Ohio, 44106-5083, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109-1998, United States
Ohio State University
Columbus, Ohio, 43210, United States
Presbyterian Medical Center - University of PA
Philadelphia, Pennsylvania, 19104, United States
University of Pennsylvania, Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Rhode Island Hospital
Providence, Rhode Island, 02906, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
Comprehensive Care Clinic
Nashville, Tennessee, 37203, United States
University of Texas, Southwestern Medical Center
Dallas, Texas, 75235-9173, United States
Univ of Texas, Galveston
Galveston, Texas, 77555-0435, United States
University of Washington (Seattle)
Seattle, Washington, 98104, United States
University of Puerto Rico
San Juan, 00936-5067, Puerto Rico
University of Witwatersrand
Parktown, Johannesburg, South Africa
Hamill RJ. Immune restoration syndrome in AIDS and mycoses. Program and abstracts of the 41st Interscience Conference on Antimicrobial Agents and Chemotherapy; December 16-19, 2001; Chicago, IL. Abtract 1272.
Nunez M, Asencio R, Valencia ME, Leal M, Gonzalez-Lahoz J, Soriano V. Rate, causes, and clinical implications of presenting with low CD4+ cell counts in the era of highly active antiretroviral therapy. AIDS Res Hum Retroviruses. 2003 May;19(5):363-8. doi: 10.1089/088922203765551719.
Sax PE, Sloan CE, Schackman BR, Grant PM, Rong J, Zolopa AR, Powderly W, Losina E, Freedberg KA; Cepac US And Actg A5164 Investigators. Early antiretroviral therapy for patients with acute aids-related opportunistic infections: a cost-effectiveness analysis of ACTG A5164. HIV Clin Trials. 2010 Sep-Oct;11(5):248-59. doi: 10.1310/hct1105-248.
Grant PM, Komarow L, Andersen J, Sereti I, Pahwa S, Lederman MM, Eron J, Sanne I, Powderly W, Hogg E, Suckow C, Zolopa A. Risk factor analyses for immune reconstitution inflammatory syndrome in a randomized study of early vs. deferred ART during an opportunistic infection. PLoS One. 2010 Jul 1;5(7):e11416. doi: 10.1371/journal.pone.0011416.
Zolopa A, Andersen J, Powderly W, Sanchez A, Sanne I, Suckow C, Hogg E, Komarow L. Early antiretroviral therapy reduces AIDS progression/death in individuals with acute opportunistic infections: a multicenter randomized strategy trial. PLoS One. 2009;4(5):e5575. doi: 10.1371/journal.pone.0005575. Epub 2009 May 18.
Primary Completion
September 2006
Actual (reported)Study Completion
August 2007
Actual (reported)Last Updated
October 15, 2014
Record last verified: 2014-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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