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Home > "A" Clinical Trials Conditions > A Comparison of Two Tests for Anti-HIV Drug Resistance  A Comparison of Two Tests for Anti-HIV Drug Resistance
A Comparison of Two Tests for Anti-HIV Drug Resistance
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to compare 2 different types of tests of the HIV virus to see which specific anti-HIV drugs would work the best. Drug resistance is a major reason for therapy failure in HIV patients. Two types of tests can detect resistance to drugs: 1) genotyping (sequencing), which looks at the DNA sequence of a virus to see whether it has developed any genetic resistance; 2) phenotyping, which looks at the ability of different drugs to suppress virus growth in the laboratory. Genotyping and phenotyping can help doctors give patients the most effective drug therapy.
Details: The emergence of drug resistance is a major factor contributing to the failure of antiretroviral therapy in HIV-infected patients. Drug resistance can be detected by genotypic or phenotypic assays, both having distinct advantages and disadvantages. Results from genotypic and phenotypic testing are helpful in excluding from the subsequent regimen drugs to which the resistance is identified, and both tests predict virologic response to salvage therapy in patients who have failed a previous regimen. Resistance testing is likely to be beneficial as an aid in selecting a salvage regimen. At entry, patients are randomized to Arm A (sequencing) or Arm B (phenotyping) and have a resistance test drawn while still receiving the current regimen even though regimen failure is suspected. The test results are available between Weeks 1 and 4, inclusive. There are weekly visits for the first 4 weeks after entry to monitor viral load and maintenance of the current failing (prestudy) regimen. If virologic failure is confirmed, a new regimen is chosen and prescribed at the first visit after resistance test results are available. [AS PER AMENDMENT 12/6/00: If the resistance assay fails to yield results, another regimen is chosen and prescribed based on the patient's medical and medication history.] If virologic failure is not confirmed, the current drug regimen is not changed. Otherwise, on-site study visits occur every 4 weeks until Week 24 and then every 8 weeks thereafter through Week 48. [AS PER AMENDMENT 12/6/00: on-site study visits occur every 4 weeks until Week 24 and then every 8 weeks thereafter]. Medical resource use is assessed at baseline and then every 8 weeks through Week 48. Quality of life is assessed at baseline and then every 16 weeks through Week 48.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: 14 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are HIV-positive. - Have failed 2 to 4 anti-HIV regimens containing 3 or more combinations of drugs. A patient has failed his/her current regimen if he/she has, within 30 days of study entry, either a viral load (level of HIV in the blood) of at least 10,000 copies/ml or 2 tests which show a viral load between 1,000 and 10,000 copies/ml. - Have taken 3 or more anti-HIV drugs for 8 or more weeks before the study. - Are at least 14 years old. - Have consent of parent or guardian if less than 18 years old. Exclusion Criteria Patients will not be eligible for this study if they: - Have failed only 1 anti-HIV drug combination. - Have failed 5 or more anti-HIV drug combinations, each containing 3 to 5 drugs. - Have had and received the results of prior resistance tests. - Have had treatment with a combination of 6 or more anti-HIV drugs. - Have problems absorbing food in the intestine. - Have had HIV vaccines. - Have taken drugs that affect the immune system or investigational drugs. - Are taking medications not allowed with protease inhibitors (PIs) if PIs would be part of their anti-HIV treatment during the study. - Have failed anti-HIV therapy due to nonadherence to medication.
Total Enrollment: 600
Location and Contact Information:
Overall Study Official:
RichardD'Aquila, Study Chair,
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Cornell Clinical Trials Unit - Chelsea Clinic
New York City, New York, 10011
United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Univ of California San Francisco
San Francisco, California, 94110
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203
United States
The CORE Ctr
Chicago, Illinois, 60612
United States
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, 75390
United States
Denver Dept of Health and Hosps
Denver, Colorado, 80262
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Brigham and Women's Hosp
Boston, Massachusetts, 02215
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Moses H Cone Memorial Hosp
Greensboro, North Carolina, 27401
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Emory Univ
Atlanta, Georgia, 30308
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699
United States
Univ of Washington
Seattle, Washington, 98104
United States
Carolinas Med Ctr
Charlotte, North Carolina, 28203
United States
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
United States
Willow Clinic
Menlo Park, California, 94025
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Univ of Puerto Rico
San Juan, , 009365067
Puerto Rico
University of California San Francisco
San Francisco, California, 941104206
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Philadelphia Veterans Administration Med Ctr
Philadelphia, Pennsylvania, 19104
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Brown Univ / Miriam Hosp
Providence, Rhode Island, 02906
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Miriam Hosp / Brown Univ
Providence, Rhode Island, 02906
United States
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Additional Information:
Study ID Numbers: ACTG A5076; AACTG A5076
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006490
Other Hiv Infections Studies:
1. Safety and Effectiveness of Anti-HIV Vaccines in HIV-Negative Adults
2. A Study of Indinavir Taken with or without DMP 266
3. A Study to Evaluate the Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients with CD4 Cell Counts of at Least 350 Cells/mm3
4. (Ro 24-2027) A Randomized, Double-Blind, Comparative Study of Dideoxycytidine (ddC) versus Zidovudine (AZT) in Patients With AIDS or Advanced ARC
5. A Double-Blind Study to Evaluate the Safety and Pharmacokinetics of L-Ofloxacin (RWJ 25213) in Subjects with HIV Infection
Related Studies:
Other HIV Infections Clinical Trials
Other Ohio Clinical Trials
Other Cincinnati Clinical Trials
A Comparison of Two Tests for Anti-HIV Drug Resistance
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