HIV-1 Resistance Testing During Antiretroviral Failure: Comparison of Sequencing Versus Phenotyping
A Comparison of Two Tests for Anti-HIV Drug Resistance
Sponsors
Source
National Institute of Allergy and Infectious Diseases (NIAID)
Brief Summary
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.
Detailed Description
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.
Overall Status
Completed
Start Date
N/A
Completion Date
N/A
Primary Completion Date
N/A
Study Type
Observational
Enrollment
600
Condition
Eligibility
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.
Gender
All
Minimum Age
14 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
|
Richard D'Aquila |
Study Chair |
|
Daniel Kuritzkes |
Study Chair |
Location
Facility |
|
Univ of Alabama at Birmingham Birmingham Alabama 35294 United States |
|
Univ of Southern California / LA County USC Med Ctr Los Angeles California 900331079 United States |
|
UCLA CARE Ctr Los Angeles California 90095 United States |
|
Willow Clinic Menlo Park California 94025 United States |
|
University of California San Francisco San Francisco California 941104206 United States |
|
Univ of California San Francisco San Francisco California 94110 United States |
|
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium San Jose California 951282699 United States |
|
San Mateo AIDS Program / Stanford Univ Stanford California 943055107 United States |
|
Stanford Univ Med Ctr Stanford California 943055107 United States |
|
Harbor UCLA Med Ctr Torrance California 90502 United States |
|
Denver Dept of Health and Hosps Denver Colorado 80262 United States |
|
Univ of Colorado Health Sciences Ctr Denver Colorado 80262 United States |
|
Univ of Miami School of Medicine Miami Florida 331361013 United States |
|
Emory Univ Atlanta Georgia 30308 United States |
|
Univ of Hawaii Honolulu Hawaii 96816 United States |
|
Northwestern Univ Med School Chicago Illinois 60611 United States |
|
Rush Presbyterian - Saint Luke's Med Ctr Chicago Illinois 60612 United States |
|
The CORE Ctr Chicago Illinois 60612 United States |
|
Johns Hopkins Hosp Baltimore Maryland 21287 United States |
|
Harvard (Massachusetts Gen 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 |
|
SUNY / Erie County Med Ctr at Buffalo Buffalo New York 14215 United States |
|
Beth Israel Med Ctr New York New York 10003 United States |
|
Cornell Clinical Trials Unit - Chelsea Clinic New York New York 10011 United States |
|
Bellevue Hosp / New York Univ Med Ctr New York New York 10016 United States |
|
Cornell Univ Med Ctr New York New York 10021 United States |
|
Mount Sinai Med Ctr New York New York 10029 United States |
|
Columbia Presbyterian Med Ctr New York New York 10032 United States |
|
Univ of North Carolina Chapel Hill North Carolina 275997215 United States |
|
Carolinas Med Ctr Charlotte North Carolina 28203 United States |
|
Duke Univ Med Ctr Durham North Carolina 27710 United States |
|
Moses H Cone Memorial Hosp Greensboro North Carolina 27401 United States |
|
Univ of Cincinnati Cincinnati Ohio 452670405 United States |
|
Case Western Reserve Univ Cleveland Ohio 44106 United States |
|
MetroHealth Med Ctr Cleveland Ohio 441091998 United States |
|
Ohio State Univ Hosp Clinic Columbus Ohio 432101228 United States |
|
Philadelphia Veterans Administration Med Ctr Philadelphia Pennsylvania 19104 United States |
|
Univ of Pennsylvania Philadelphia Pennsylvania 19104 United States |
|
Univ of Pittsburgh Pittsburgh Pennsylvania 15213 United States |
|
Brown Univ / Miriam Hosp Providence Rhode Island 02906 United States |
|
Miriam Hosp / Brown Univ Providence Rhode Island 02906 United States |
|
Julio Arroyo West Columbia South Carolina 29169 United States |
|
Vanderbilt Univ Med Ctr Nashville Tennessee 37203 United States |
|
Univ of Texas, Southwestern Med Ctr of Dallas Dallas Texas 75390 United States |
|
Univ of Washington Seattle Washington 98104 United States |
|
Univ of Puerto Rico San Juan 009365067 Puerto Rico |
Location Countries
Country
Puerto Rico
United States
Verification Date
2004-07-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Keywords
Has Expanded Access
No
Condition Browse
Secondary Id
AACTG A5076
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study First Submitted
November 8, 2000
Study First Submitted Qc
August 30, 2001
Study First Posted
August 31, 2001
Last Update Submitted
September 24, 2008
Last Update Submitted Qc
September 24, 2008
Last Update Posted
September 25, 2008
ClinicalTrials.gov processed this data on December 09, 2019
Conditions
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conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.