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Using Drug Levels and Drug Resistance Testing to Select Effective Anti-HIV Drug Combinations in Patients with Drug-resistant HIV Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Using Drug Levels and Drug Resistance Testing to Select Effective Anti-HIV Drug Combinations in Patients with Drug-resistant HIV conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Using Drug Levels and Drug Resistance Testing to Select Effective Anti-HIV Drug Combinations in Patients with Drug-resistant HIV Clinical research trials and Using Drug Levels and Drug Resistance Testing to Select Effective Anti-HIV Drug Combinations in Patients with Drug-resistant HIV medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Using Drug Levels and Drug Resistance Testing to Select Effective Anti-HIV Drug Combinations in Patients with Drug-resistant HIV. Using Drug Levels and Drug Resistance Testing to Select Effective Anti-HIV Drug Combinations in Patients with Drug-resistant HIV Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Using Drug Levels and Drug Resistance Testing to Select Effective Anti-HIV Drug Combinations in Patients with Drug-resistant HIV clinical trial. Test subjects typically obtain the finest healthcare available for their Using Drug Levels and Drug Resistance Testing to Select Effective Anti-HIV Drug Combinations in Patients with Drug-resistant HIV condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "U" Clinical Trials Conditions > Using Drug Levels and Drug Resistance Testing to Select Effective Anti-HIV Drug Combinations in Patients with Drug-resistant HIV  Using Drug Levels and Drug Resistance Testing to Select Effective Anti-HIV Drug Combinations in Patients with Drug-resistant HIV
Using Drug Levels and Drug Resistance Testing to Select Effective Anti-HIV Drug Combinations in Patients with Drug-resistant HIV
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: Because people infected with HIV strains that are resistant to anti-HIV drugs have fewer effective treatment options, selecting an effective anti-HIV drug combination is difficult. A combination of protease inhibitors (PIs), when added to a patient’s current anti-HIV therapy, may decrease viral load and increase drug activity. Tests that measure drug levels in the blood and tests to evaluate the drug resistance of HIV may also be helpful in choosing the best anti-HIV drug combination for a patient. This study will determine whether using these tests to choose a drug combination and adding PIs to that combination will improve the patient’s response to anti-HIV therapy.
Details: Treatment options are limited for HIV infected individuals who have extensive treatment experience and harbor resistance to antiretrovirals (ARVs) from multiple drug classes. Increasing the concentration of PIs in a regimen may be one way to provide more substantial ARV activity. It is uncertain how combining specific PIs with RTV affects viral susceptibility and ARV effect. The relationship of PI concentration (e.g., Cmin) to virus susceptibility (IC50) may be a better predictor of treatment outcome than susceptibility alone. This study will evaluate the predictive value of pharmacokinetic-adjusted phenotypic susceptibility (C12h/IC50) on ARV response to ritonavir (RTV)-boosted regimens in patients failing their current PI-containing regimens. Participants will have blood drawn during a screening visit for phenotypic assay and to determine viral load. At study entry, participants will discontinue their PIs while continuing to take their other ARVs. Each participant and his or her doctor will choose to add one of three RTV-boosted regimens: 1) indinavir (IDV) and RTV; 2) fosamprenavir (FPV) and RTV; or 3) lopinavir (LPV)/RTV plus additional RTV. Participants will take this regimen for 14 days. On Day 14, patients will have a 12-hour pharmacokinetic evaluation. On Day 15, patients will add tenofovir disoproxil fumarate (TDF) to their regimens and may choose to modify their other ARVs while continuing their RTV-boosted therapy. Participants will have additional study visits at Weeks 4, 8, 16, and 24. Study visits will include a physical exam and blood and urine tests. Participants will complete adherence questionnaires four times during the course of the study.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - HIV infected - Viral load greater than 2500 copies/ml within 60 days of study entry - On regimen with at least one PI for a total of at least 48 weeks - On the same PI regimen for at least 90 days prior to study entry - Decreased susceptibility to two of these three PIs: LPV, APV, and IDV (documented by phenotype within 90 days prior to study entry) - Have taken a nonnucleoside reverse transcriptase inhibitor (NNRTI) for at least 12 weeks anytime in previous treatment history, or have decreased susceptibility to at least two NNRTIs - Have taken two or more nucleoside reverse transcriptase inhibitors (NRTIs) for at least 12 weeks anytime in previous treatment history - Agrees to use acceptable methods of contraception - Weighs 88 lbs or more Exclusion Criteria: - Cannot tolerate RTV, APV, FPV, LPV/RTV, or IDV - Use of HIV vaccines, investigational agents, hydroxyurea, or therapy to affect the immune system within 60 days of study entry - Serious kidney problems - Pregnancy or breastfeeding - Alcohol or drug use that would interfere with the study - Serious illness that requires treatment or hospitalization (patients stable on therapy or who have finished therapy at least 14 days before study entry may be eligible)
Total Enrollment: 108
Location and Contact Information:
Overall Study Official:
JosephEron, Study Chair, University of North Carolina at Chapel Hill
Univ of Hawaii *Recruiting*
Honolulu, Hawaii, 96816-2396
United States
Recruiting Debra Ogata-Arakaki 808-737-2751
Univ of California, San Diego *Recruiting*
San Diego, California, 92103
United States
Recruiting Jill Kunkel 619-543-8080
San Mateo County AIDS Program *Recruiting*
Stanford, California, 94305-5107
United States
Recruiting Debbie Slamowitz 650-723-2804
UCLA School of Medicine *Not yet recruiting*
Los Angeles, California, 90095-1793
United States
Not yet recruiting
Univ of Alabama at Birmingham *Recruiting*
Birmingham, Alabama, 35924-2050
United States
Recruiting Karen Savage 205-975-7925
Case Western Reserve Univ *No longer recruiting*
Cleveland, Ohio, 44106
United States
No longer recruiting
Ohio State Univ *Recruiting*
Columbus, Ohio, 43210
United States
Recruiting Todd Lusch 614-293-8112
University of Washington (Seattle) *Recruiting*
Seattle, Washington, 98104
United States
Recruiting Jeanne Conley 206-731-8877
Univ of Iowa Hosp and Clinics *Recruiting*
Iowa City, Iowa, 52242-1201
United States
Recruiting Julie Katseres 319-353-8441
San Francisco Gen Hosp *Recruiting*
San Francisco, California, 94110
United States
Recruiting Michele Downing 415-514-0550
Univ of Maryland, Institute of Human Virology *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Susan LaSalvia 410-706-2785
Bellevue Hosp / New York Univ Med Ctr *Recruiting*
New York City, New York, 10016
United States
Recruiting Maura Laverty 212-263-6565
Beth Israel Med Ctr *Recruiting*
New York City, New York, 10003
United States
Recruiting Ann Marshak 212-420-4432
Univ of Texas, Southwestern Med Ctr *Recruiting*
Dallas, Texas, 75235-9173
United States
Recruiting Chip Lohner 214-590-0414
Indiana Univ Hosp *Recruiting*
Indianapolis, Indiana, 462025250
United States
Recruiting Beth Zwickl 317-274-8456
Willow Clinic *Recruiting*
Stanford, California, 94305-5107
United States
Recruiting Debbie Slamowitz 650-723-2804
Univ of North Carolina *Recruiting*
Chapel Hill, North Carolina, 275997215
United States
Recruiting Cheryl Marcus 919-843-8761
Duke Univ Med Ctr *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Suzanne Aycock 919-684-8216
Stanford Univ *Recruiting*
Stanford, California, 94305-5107
United States
Recruiting Debbie Slamowitz 650-723-2804
Univ of Southern California / LA County USC Med Ctr *Recruiting*
Los Angeles, California, 90033-1079
United States
Recruiting Luis Mendez 323-343-8283
Washington University (St. Louis) *Recruiting*
St. Louis, Missouri, 63108-22138
United States
Recruiting Michael Klebert 314-454-0058
Beth Israel Deaconess - West Campus *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Helen Fitch 617-632-0785
Methodist Hosp of Indiana / Life Care Clinic *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Sarah Ryan 317-929-2917
Univ of Miami School of Medicine *Recruiting*
Miami, Florida, 331361013
United States
Recruiting Leslie Thompson 305-243-3838
UC Davis Med Ctr *Recruiting*
Sacramento, California, 95814
United States
Recruiting Susan Hulse 916-734-8637
Univ of California, Davis Med Ctr *Recruiting*
Sacramento, California, 95814
United States
Recruiting Susan Hulse 916-734-8637
Univ of Colorado Health Sciences Ctr *Recruiting*
Denver, Colorado, 80262
United States
Recruiting M Ray 303-372-5535
Wishard Hosp *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Scott Hamilton 317-630-6023
Rush-Presbyterian/St. Lukes (Chicago) *Recruiting*
Chicago, Illinois, 60612-3806
United States
Recruiting Jan Fritsche 312-942-4810
Univ of Texas Galveston *Recruiting*
Galveston, Texas, 775550435
United States
Recruiting Carrie Derkowski 409-747-0241
Additional Information:
Study ID Numbers: ACTG A5126; AACTG A5126
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027339
Other Hiv Infections Studies:
1. Adding New Drugs for HIV Infected Patients Failing Current Therapy
2. Comparison of Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS
3. The Effects of AZT and Ibuprofen on HIV-Infected Patients with Hemophilia
4. Identifying Emergency Room Patients Who Have Recently Been Infected with HIV
5. The Effects of Treatment for Mycobacterium Avium Complex (MAC) on the Cells of HIV-Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Using Drug Levels and Drug Resistance Testing to Select Effective Anti-HIV Drug Combinations in Patients with Drug-resistant HIV
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