When to Start Anti-HIV Drugs in Patients With Opportunistic Infections
A Phase IV Study of Antiretroviral Therapy for HIV Infected Adults Presenting With Acute Opportunistic Infections: Immediate Versus Deferred Initiation of Antiretroviral Therapy
2 other identifiers
interventional
283
3 countries
45
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 hiv-infections
Started Mar 2003
Longer than P75 for phase_4 hiv-infections
45 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
First Submitted
Initial submission to the registry
February 19, 2003
CompletedFirst Posted
Study publicly available on registry
February 20, 2003
CompletedStudy Start
First participant enrolled
March 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedOctober 15, 2014
October 1, 2014
3.5 years
February 19, 2003
October 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival, recurrence of presenting OI/bacterial infection (BI) or incidence of new AIDS-defining events, and HIV-1 plasma viral load at Week 48
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- HIV-1 infected
- Currently being treated for OI (including Pneumocystis carinii pneumonia \[PCP\]; cryptococcal meningitis; disseminated histoplasmosis; disseminated Mycobacterium avium complex \[MAC\]; cytomegalovirus \[CMV\] retinitis; CMV encephalitis; toxoplasmic encephalitis; other atypical non-tuberculous, non-MAC mycobacterial infections; or other serious, invasive BIs). Participants who have tuberculosis (TB) alone are ineligible for this study. Participants with bacterial pneumonia or serious BI must have a CD4 count less than 200 cells/mm3 within 30 days prior to study entry. Participants with other serious OIs, including other AIDS-defining and -related OIs for which appropriate therapy other than ART exists are eligible, pending investigator approval. Participants' current OI treatment must have been started within 14 days prior to study entry, but may have been discontinued prior to study entry.
- Able to take oral medications
- Parent or guardian willing to provide informed consent, if applicable
- Willing to use acceptable methods of contraception
You may not qualify if:
- Any ART within 8 weeks prior to study entry
- or more days of any ARV within 6 months prior to entry
- History of more than one virologic, immunologic, or clinical treatment failure while on a HAART regimen, or a history of more than one regimen change for unknown reasons
- Systemic cancer chemotherapy within 30 days prior to study entry
- Immunomodulators within 30 days prior to study entry, including growth factors, immune globulin, interleukins, and interferons (unless for hepatitis C virus or Kaposi's sarcoma)
- Investigational ARV agents at study entry
- Systemic investigational agents (except ARV drugs) within 30 days prior to study entry will be allowed at the study official's discretion
- Anticipated use of certain medications
- Kidney failure requiring dialysis
- Current drug or alcohol use that, in the opinion of the study official, would interfere with the study
- Treatment for current, first-treated, and diagnosed OI or BI for more than 14 days prior to study entry
- Known resistance to ART that prohibits administration of an effective ART regimen
- Current OI has recurred within 90 days prior to study entry. Recurrent BIs are not excluded.
- Pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
University 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
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
Related Publications (7)
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.
PMID: 11549544BACKGROUNDBartlett 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.
PMID: 11504958BACKGROUNDHamill 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.
BACKGROUNDNunez 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.
PMID: 12803995BACKGROUNDSax 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.
PMID: 21126955RESULTGrant 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.
PMID: 20617176DERIVEDZolopa 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.
PMID: 19440326DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Andrew R. Zolopa, MD
Division of Infectious Diseases, Stanford University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
February 19, 2003
First Posted
February 20, 2003
Study Start
March 1, 2003
Primary Completion
September 1, 2006
Study Completion
August 1, 2007
Last Updated
October 15, 2014
Record last verified: 2014-10