Using Drug Levels in the Blood to Guide Therapy in HIV Infected Patients Taking a Protease Inhibitor
A Phase II Randomized Controlled Trial Evaluating the Impact of Therapeutic Drug Monitoring (TDM) on Virologic Response to a Salvage Regimen in Subjects With a Normalized Inhibitory Quotient (NIQ) Less Than or Equal to 1 to One or More Protease Inhibitors
2 other identifiers
interventional
360
2 countries
47
Brief Summary
Drug resistance testing can be used to see which anti-HIV drugs are likely to suppress the growth of HIV and to select an anti-HIV regimen for HIV infected patients who have failed previous drug regimens. Therapeutic drug monitoring (TDM) is a process that involves measuring blood levels of a drug and may further increase the benefits that resistance testing offers by optimizing protease inhibitor (PI) drug concentrations. The purpose of this study is to determine whether changing the dose of PIs, as indicated by TDM, reduces the viral load in PI-experienced patients. Hypothesis: Treatment-naive study participants who undergo TDM and whose clinicians' interpret their TDM results and adjust their PI doses will have better virologic response rates and decreased toxicities (and thus better treatment outcomes) than participants who do not undergo TDM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hiv-infections
Started Jun 2002
Longer than P75 for phase_3 hiv-infections
47 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
June 1, 2002
CompletedFirst Submitted
Initial submission to the registry
July 16, 2002
CompletedFirst Posted
Study publicly available on registry
July 17, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedJuly 13, 2010
December 1, 2008
4.8 years
July 16, 2002
July 12, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in log10 plasma HIV-1 RNA concentration from Step 2 entry (Week 4) to Week 24 (20 weeks post-randomization)
change in log10 plasma HIV-1 RNA concentration from study entry to Week 24 (20 weeks post-randomization)
Interventions
Eligibility Criteria
You may qualify if:
- HIV infected
- Viral load of 1000 copies/ml or more at study screening
- At least one viral load of 400 copies/ml or more within 6 months of study entry while on the failing antiretroviral regimen
- Virologic failure of at least one combination (two or more drugs) antiretroviral regimen, with at least one of these failing regimens containing a PI. Low dose ritonavir and hydroxyurea are not counted as antiretrovirals.
- Currently on a failing combination antiretroviral regimen
- Plan to initiate a salvage regimen containing a PI within 7 days of study entry
- Acceptable methods of contraception while receiving the study medications and for 6 weeks after stopping the medications. Participants who are currently taking efavirenz and who have undergone surgery to prevent conception (e.g., hysterectomy, tubal ligation, vasectomy) must provide physician's documentation of their current regimen and of their previous surgery.
- Resistance to at least one drug in the failing regimen, documented within 90 days of study entry
- Karnofsky performance scale of 70 or more within 30 days prior to study entry
You may not qualify if:
- Growth factors, interleukins, interferons (except for the treatment of hepatitis C), non-FDA approved systemic drugs, and HIV vaccines within 30 days of study entry
- Require certain medications prior to or during the study
- Certain heart conditions, if starting a PI-based regimen as the salvage regimen
- Acute illness or infection requiring treatment within 14 days of study entry
- Any condition that would limit ability to participate in the study
- Cancer requiring radiation or systemic chemotherapy
- Active drug or alcohol use or dependence that would interfere with the ability to meet study requirements
- Acute or chronic pancreatitis
- Planned use of hydroxyurea in the salvage regimen
- Pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35924-2050, United States
Univ of Southern California
Los Angeles, California, 90033-1079, United States
UCLA School of Medicine
Los Angeles, California, 90095, United States
Univ of California, San Diego Antiviral Research Center (AVRC)
San Diego, California, 92103, United States
Univ of California San Francisco
San Francisco, California, 94110, United States
San Mateo County AIDS Program
Stanford, California, 94305-5107, United States
Santa Clara Valley Med Ctr
Stanford, California, 94305-5107, United States
Willow Clinic
Stanford, California, 94305-5107, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Univ of Miami
Miami, Florida, 33136-1013, United States
Univ of Hawaii
Honolulu, Hawaii, 96816-2396, United States
Northwestern Univ
Chicago, Illinois, 60611-3015, United States
The CORE Ctr
Chicago, Illinois, 60612, United States
Methodist Hosp of Indiana
Indianapolis, Indiana, 46202-1261, United States
Indiana Univ Hosp
Indianapolis, Indiana, 46202-5250, United States
Wishard Hosp
Indianapolis, Indiana, 46202, United States
Univ of Maryland, Institute of Human Virology
Baltimore, Maryland, 21201, United States
Johns Hopkins Univ
Baltimore, Maryland, 21287-8106, United States
Harvard (Masschusetts General Hosp)
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess-West Campus
Boston, Massachusetts, 02215, United States
Brigham and Women's Hosp
Boston, Massachusetts, 02215, United States
Univ of Minnesota
Minneapolis, Minnesota, 55455-0392, United States
St. Louis Connect Care
St Louis, Missouri, 63108-2138, United States
Washington Univ (St. Louis)
St Louis, Missouri, 63108-2138, United States
SUNY-Buffalo (Rochester)
Buffalo, New York, 14215, United States
Beth Israel Medical Center
New York, New York, 10003, United States
Chelsea Clinic
New York, New York, 10011, United States
New York University - Bellevue
New York, New York, 10016, United States
Long Beach Memorial (Pediatric)
New York, New York, 10021, United States
Columbia Univ
New York, New York, 10032, United States
Community Health Network Inc
Rochester, New York, 14642, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
University of North Carolina
Chapel Hill, North Carolina, 27514, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Ohio State Univ
Cincinnati, Ohio, 45267-0405, United States
Univ of Cincinnati
Cincinnati, Ohio, 45267-0405, United States
Case Western Reserve Univ
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44109-1998, United States
MetroHealth Med Ctr
Cleveland, Ohio, 44109-1998, United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Rhode Island Hosp
Providence, Rhode Island, 02906, United States
Stanley Street Treatment and Resource
Providence, Rhode Island, 02906, United States
The Miriam Hosp
Providence, Rhode Island, 02906, United States
Comprehensive Care Clinic
Nashville, Tennessee, 37203, United States
Univ of Texas, Galveston
Galveston, Texas, 77555-0435, United States
Univ of Washington (Seattle)
Seattle, Washington, 98104, United States
University of Puerto Rico
San Juan, 00936-5067, Puerto Rico
Related Publications (6)
Clevenbergh P, Mouly S, Sellier P, Badsi E, Cervoni J, Vincent V, Trout H, Bergmann JF. Improving HIV infection management using antiretroviral plasma drug levels monitoring: a clinician's point of view. Curr HIV Res. 2004 Oct;2(4):309-21. doi: 10.2174/1570162043351129.
PMID: 15544452BACKGROUNDDuong M, Golzi A, Peytavin G, Piroth L, Froidure M, Grappin M, Buisson M, Kohli E, Chavanet P, Portier H. Usefulness of therapeutic drug monitoring of antiretrovirals in routine clinical practice. HIV Clin Trials. 2004 Jul-Aug;5(4):216-23. doi: 10.1310/NXJU-9ERQ-ADWW-UC5X.
PMID: 15472796BACKGROUNDKiser JJ, Anderson PL, Gerber JG. Therapeutic drug monitoring: pharmacologic considerations for antiretroviral drugs. Curr HIV/AIDS Rep. 2005 Jun;2(2):61-7. doi: 10.1007/s11904-005-0020-8.
PMID: 16091250BACKGROUNDRakhmanina NY, van den Anker JN, Soldin SJ. Therapeutic drug monitoring of antiretroviral therapy. AIDS Patient Care STDS. 2004 Jan;18(1):7-14. doi: 10.1089/108729104322740866.
PMID: 15006189BACKGROUNDRendon A, Nunez M, Jimenez-Nacher I, Gonzalez de Requena D, Gonzalez-Lahoz J, Soriano V. Clinical benefit of interventions driven by therapeutic drug monitoring. HIV Med. 2005 Sep;6(5):360-5. doi: 10.1111/j.1468-1293.2005.00321.x.
PMID: 16156885BACKGROUNDDiFrancesco R, Rosenkranz S, Mukherjee AL, Demeter LM, Jiang H, DiCenzo R, Dykes C, Rinehart A, Albrecht M, Morse GD. Quality assessment for therapeutic drug monitoring in AIDS Clinical Trials Group (ACTG 5146): a multicenter clinical trial. Ther Drug Monit. 2010 Aug;32(4):458-66. doi: 10.1097/FTD.0b013e3181e4427a.
PMID: 20592644RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lisa Demeter, MD
Infectious Diseases Unit, University of Rochester Medical Center
- STUDY CHAIR
Mary Albrecht, MD
Division of Infectious Diseases, Beth Israel Deaconess Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
July 16, 2002
First Posted
July 17, 2002
Study Start
June 1, 2002
Primary Completion
April 1, 2007
Study Completion
August 1, 2007
Last Updated
July 13, 2010
Record last verified: 2008-12