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Using Drug Levels in the Blood to Guide Therapy in HIV Infected Patients Taking a Protease Inhibitor Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Using Drug Levels in the Blood to Guide Therapy in HIV Infected Patients Taking a Protease Inhibitor conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Using Drug Levels in the Blood to Guide Therapy in HIV Infected Patients Taking a Protease Inhibitor Clinical research trials and Using Drug Levels in the Blood to Guide Therapy in HIV Infected Patients Taking a Protease Inhibitor healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Using Drug Levels in the Blood to Guide Therapy in HIV Infected Patients Taking a Protease Inhibitor. Using Drug Levels in the Blood to Guide Therapy in HIV Infected Patients Taking a Protease Inhibitor Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Using Drug Levels in the Blood to Guide Therapy in HIV Infected Patients Taking a Protease Inhibitor clinical trial. Participants typically obtain the most effective healthcare available for their Using Drug Levels in the Blood to Guide Therapy in HIV Infected Patients Taking a Protease Inhibitor condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "U" Clinical Trials Conditions > Using Drug Levels in the Blood to Guide Therapy in HIV Infected Patients Taking a Protease Inhibitor  Using Drug Levels in the Blood to Guide Therapy in HIV Infected Patients Taking a Protease Inhibitor
Using Drug Levels in the Blood to Guide Therapy in HIV Infected Patients Taking a Protease Inhibitor
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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) 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, improves immune system response in PI-experienced patients.
Details: The use of drug resistance testing to guide the selection of an antiretroviral regimen for patients in whom current therapy is failing has gained growing acceptance in clinical practice. Genotypic and phenotypic resistance testing has been associated with improved short-term virologic outcome in prospective interventional trials. There is also growing evidence that monitoring drug levels, particularly of PIs, may add to the benefit provided by resistance testing. This study will assess the impact of TDM and resistance testing on lowering viral load in treatment-experienced patients and also evaluate the mean change in plasma HIV RNA from study entry to Step 2 of the study. No antiretrovirals will be provided by this study. Patients failing at least one combination antiretroviral regimen will have a screening drug resistance test performed while remaining on the failing regimen. They will be followed for a maximum of 48 weeks. Patients will begin a salvage antiretroviral regimen selected by the patient's clinician using results of the resistance test (Step 1). Two weeks after initiation of the salvage regimen, patients will have timed plasma samples obtained for PI trough levels. The results of the trough levels will be used to calculate a normalized inhibitory quotient (NIQ) in order to determine eligibility for randomization into Step 2 at Week 4. In Step 2, patients with an NIQ of 1 or less will be assigned randomly to one of two arms. Arm A will receive standard of care (SOC) only, while patients in Arm B will receive SOC plus dose-adjusted PIs based on the NIQ. Clinical and viral load assessment will be conducted at screening, entry, and Weeks 4, 10, 16, 24, 32, 40, and 48. Arm B patients will also have their PI trough levels checked at Weeks 6 and 10. Patients with an NIQ greater than 1 will be assigned to observational Arm C (open to up to 50 enrollees) or will stop their involvement in the study. Patients in Arm A, B, or C who have a viral load of 1000 copies/ml or greater or experience virologic failure at or after Week 24 will be eligible to receive a second resistance test and enter Step 3. Participants in Step 3 will begin a second salvage regimen and PI trough levels will be measured after 2, 6, and 10 weeks of salvage therapy. Those with an NIQ greater than 1, or with an NIQ of 1 or less (and do not wish to dose escalate), will be followed on Step 3 for a maximum of 48 weeks after study entry.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria for Step 1 - 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 not counted as antiretrovirals) - Currently on failing combination antiretroviral regimen - Plan to initiate a salvage regimen containing a PI - Acceptable methods of contraception while receiving the study medications and for 6 weeks after stopping the medications - Resistance to at least one drug in the failing regimen, documented within 90 days of study entry - Karnofsky performance scale of 70 or greater within 30 days prior to study entry Exclusion Criteria - Growth factors, interleukins, interferons (except for treatment of hepatitis C), non-FDA approved systemic drugs, and HIV vaccines within 30 days of study entry - Certain drugs used prior to study entry - 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
Total Enrollment: 280
Location and Contact Information:
Overall Study Official:
LisaDemeter, Study Chair, University of Rochester Medical Center, Infectious Diseases Unit
UCLA School of Medicine *Recruiting*
Los Angeles, California, 90095
United States
Recruiting Susan McCarthy 310-206-8029
Univ of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Christine Tripoli 412-647-0771
Santa Clara Valley Med Ctr *Recruiting*
Stanford, California, 94305-5107
United States
Recruiting Debbie Slamowitz 650-723-2804
Willow Clinic *Recruiting*
Stanford, California, 94305-5107
United States
Recruiting Debbie Slamowitz 650-723-2804
Univ of Maryland, Institute of Human Virology *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Sue LaSalvia 410-706-2785
San Mateo County AIDS Program *Recruiting*
Stanford, California, 94305-5107
United States
Recruiting Debbie Slamowitz 650-723-2804
MetroHealth Med Ctr *Recruiting*
Cleveland, Ohio, 44109-1998
United States
Recruiting Ann Conrad 216-778-5489
Indiana Univ Hosp *Recruiting*
Indianapolis, Indiana, 46202-5250
United States
Recruiting Beth Zwickl 317-274-8456
Duke Univ Med Ctr *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Suzanne Aycock 919-684-8216
Long Beach Memorial (Pediatric) *Recruiting*
New York City, New York, 10021
United States
Recruiting Valery Hughes 212-746-4393
Univ of Colorado Health Sciences Ctr *Recruiting*
Denver, Colorado, 80262
United States
Recruiting M Ray 303-372-5535
Univ of Texas, Galveston *Recruiting*
Galveston, Texas, 77555-0435
United States
Recruiting Carrier Derkowski 409-747-0241
Univ of Minnesota *Recruiting*
Minneapolis, Minnesota, 55455-0392
United States
Recruiting Christine Fietzer 612-625-1462
Univ of Southern California *Recruiting*
Los Angeles, California, 90033-1079
United States
Recruiting Luis Mendez 323-343-8283
Univ of Miami *Recruiting*
Miami, Florida, 33136-1013
United States
Recruiting Leslie Thompson 305-243-3838
Ohio State Univ *Recruiting*
Cincinnati, Ohio, 45267-0405
United States
Recruiting Tammy Powell 513-584-8373
Community Health Network Inc *Recruiting*
Rochester, New York, 14642
United States
Recruiting Carol Greisberger 585-275-2740
The Miriam Hosp *Recruiting*
Providence, Rhode Island, 02906
United States
Recruiting Joan Gormley 401-793-4396
Univ of California San Francisco *Recruiting*
San Francisco, California, 94110
United States
Recruiting Julieann Lewis 415-514-0550
Wishard Hosp *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Scott Hamilton 317-630-6023
Brigham and Women's Hosp *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Carolyn Koziol 617-732-5635
Univ of Rochester Medical Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting Carol Greisberger 585-275-2740
Washington Univ (St. Louis) *Recruiting*
St. Louis, Missouri, 63108-2138
United States
Recruiting Michael Klebert 314-454-0058
Univ of Washington (Seattle) *Recruiting*
Seattle, Washington, 98104
United States
Recruiting Jeanne Conley 206-731-8877
St. Louis Connect Care *No longer recruiting*
St. Louis, Missouri, 63108-2138
United States
No longer recruiting
Chelsea Clinic *Recruiting*
New York City, New York, 10011
United States
Recruiting Todd Stroberg 212-746-7198
Univ of Cincinnati *Recruiting*
Cincinnati, Ohio, 45267-0405
United States
Recruiting Tammy Powell 513-584-8373
Rhode Island Hosp *Recruiting*
Providence, Rhode Island, 02906
United States
Recruiting Joan Gormley 401-793-4396
Cleveland Clinic *Recruiting*
Cleveland, Ohio, 44109-1998
United States
Recruiting Michael Chance 216-778-5489
Comprehensive Care Clinic *Recruiting*
Nashville, Tennessee, 37203
United States
Recruiting Janet Nicotera 615-467-0154
Univ of Alabama at Birmingham *Recruiting*
Birmingham, Alabama, 35924-2050
United States
Recruiting Karen Savage 205-975-7925
University of California, San Diego Antiviral Research Center (AVRC) *Recruiting*
San Diego, California, 92103
United States
Recruiting Jill Kunkel 619-543-8080
Univ of Hawaii *Recruiting*
Honolulu, Hawaii, 96816-2396
United States
Recruiting Debra Ogata-Arakaki 808-737-2751
New York University - Bellevue *Recruiting*
New York City, New York, 10016
United States
Recruiting Maura Laverty 212-263-6565
Stanley Street Treatment and Resource *Recruiting*
Providence, Rhode Island, 02906
United States
Recruiting Joan Gormley 401-793-4396
Columbia Univ *Recruiting*
New York City, New York, 10032
United States
Recruiting Mykyelle Crawford 212-305-2665
Methodist Hosp of Indiana *Recruiting*
Indianapolis, Indiana, 46202-1261
United States
Recruiting Sarah Ryan 317-929-2917
Harvard (Masschusetts General Hosp) *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Teri Flynn 617-726-3819
Northwestern Univ *Recruiting*
Chicago, Illinois, 60611-3015
United States
Recruiting Baiba Berzins 312-695-5012
The CORE Ctr *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Joanne Despotes 312-572-4545
Beth Israel Deaconess- West Campus *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Helen Fitch 617-632-0785
Beth Israel Medical Center *Recruiting*
New York City, New York, 10003
United States
Recruiting Ann Marshak 212-420-4432
Case Western Reserve Univ *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Michael Chance 216-844-8051
Johns Hopkins Univ *Recruiting*
Baltimore, Maryland, 21287-8106
United States
Recruiting Ilene Wiggins 410-614-2766
SUNY-Buffalo (Rochester) *Recruiting*
Buffalo, New York, 14215
United States
Recruiting Rachele Cruz 716-898-3933
Additional Information:
Study ID Numbers: ACTG A5146; AACTG A5146
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041769
Other Hiv Infections Studies:
1. Viracept Expanded Access Program
2. HIV-Associated Heart Disease
3. A Randomized Phase II Study of Two Doses of Interferon alfa-2a (IFN alfa-2a) in Combination With Zidovudine (AZT) and Dideoxycytidine (ddC) Versus AZT and ddC Only in Patients With HIV Infection and Less Than 400 CD4 Cells/mm3
4. A Comparative Study of a Combination of Zidovudine, Didanosine, and Double-Blinded Nevirapine Versus a Combination of Zidovudine and Didanosine
5. A Study of GENEVAX-HIV, a Possible Vaccine
Related Studies:
Other HIV Infections Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
Using Drug Levels in the Blood to Guide Therapy in HIV Infected Patients Taking a Protease Inhibitor
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