HIV InfectionsNCT00006490
A Comparison of Two Tests for Anti-HIV Drug Resistance
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 47 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 600 participants
- Where
- 47 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
47 sites in 2 countries.
47 sites in 2 countries
United States46 sites
Emory Univ
Atlanta, Georgia, 30308
Johns Hopkins Hosp
Baltimore, Maryland, 21287
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
Brigham and Women's Hosp
Boston, Massachusetts, 02215
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
Carolinas Med Ctr
Charlotte, North Carolina, 28203
Northwestern Univ Med School
Chicago, Illinois, 60611
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
The CORE Ctr
Chicago, Illinois, 60612
Univ of Cincinnati
Cincinnati, Ohio, 452670405
Case Western Reserve Univ
Cleveland, Ohio, 44106
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, 75390
Denver Dept of Health and Hosps
Denver, Colorado, 80262
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
Duke Univ Med Ctr
Durham, North Carolina, 27710
Moses H Cone Memorial Hosp
Greensboro, North Carolina, 27401
Univ of Hawaii
Honolulu, Hawaii, 96816
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
UCLA CARE Ctr
Los Angeles, California, 90095
Willow Clinic
Menlo Park, California, 94025
Univ of Miami School of Medicine
Miami, Florida, 331361013
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203
Beth Israel Med Ctr
New York, New York, 10003
Cornell Clinical Trials Unit - Chelsea Clinic
New York, New York, 10011
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
Cornell Univ Med Ctr
New York, New York, 10021
Mount Sinai Med Ctr
New York, New York, 10029
Columbia Presbyterian Med Ctr
New York, New York, 10032
Philadelphia Veterans Administration Med Ctr
Philadelphia, Pennsylvania, 19104
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Brown Univ / Miriam Hosp
Providence, Rhode Island, 02906
Miriam Hosp / Brown Univ
Providence, Rhode Island, 02906
University of California San Francisco
San Francisco, California, 941104206
Univ of California San Francisco
San Francisco, California, 94110
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699
Univ of Washington
Seattle, Washington, 98104
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
Stanford Univ Med Ctr
Stanford, California, 943055107
Harbor UCLA Med Ctr
Torrance, California, 90502
Julio Arroyo
West Columbia, South Carolina, 29169
About this study
Official title: HIV-1 Resistance Testing During Antiretroviral Failure: Comparison of Sequencing Versus Phenotyping
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.
Read the 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.
- Conditions
- HIV Infections
- Keywords
- HIV-1, Drug Resistance, Microbial, Sequence Analysis, DNA, Microbial Sensitivity Tests, Genotype, Phenotype, Anti-HIV Agents
- Medical subject headings
- HIV Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 600 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Richard D'Aquila, Study chairDaniel Kuritzkes, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006490
- Sponsor's protocol ID
- ACTG A5076
- Other IDs
- AACTG A5076
- Status last verified
- Jul 2004
- First submitted
- 8 Nov 2000
- Last updated
- 25 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV-1 Resistance Testing During Antiretroviral Failure: Comparison of Sequencing Versus Phenotyping
- ClinicalTrials.gov ID
- NCT00006490
- Acronym / sponsor ID
- ACTG A5076
- Conditions
- HIV Infections
- Keywords
- HIV-1, Drug Resistance, Microbial, Sequence Analysis, DNA, Microbial Sensitivity Tests, Genotype, Phenotype, Anti-HIV Agents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard D'Aquila study chair
Daniel Kuritzkes study chair
47 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 47 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2008.