Using Drug Levels and Drug Resistance Testing to Select Effective Anti-HIV Drug Combinations in Patients With Drug-resistant HIV
NCT ID: NCT00027339
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
53 participants
INTERVENTIONAL
2005-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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lopinavir/ritonavir
indinavir sulfate
tenofovir disoproxil fumarate
ritonavir
fosamprenavir
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
13 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Douglas Richman, MD
Role: STUDY_CHAIR
University of California, San Diego
Joseph J. Eron, MD
Role: STUDY_CHAIR
University of North Carolina, Chapel Hill
Locations
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USC CRS
Los Angeles, California, United States
Stanford CRS
Palo Alto, California, United States
UC Davis Medical Center
Sacramento, California, United States
Ucsd, Avrc Crs
San Diego, California, United States
University of Colorado Hospital CRS
Aurora, Colorado, United States
Univ. of Miami AIDS CRS
Miami, Florida, United States
Indiana Univ. School of Medicine, Wishard Memorial
Indianapolis, Indiana, United States
Methodist Hosp. of Indiana
Indianapolis, Indiana, United States
Beth Israel Med. Ctr., ACTU
New York, New York, United States
NY Univ. HIV/AIDS CRS
New York, New York, United States
Unc Aids Crs
Chapel Hill, North Carolina, United States
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, United States
Vanderbilt Therapeutics CRS
Nashville, Tennessee, United States
Puerto Rico-AIDS CRS
San Juan, , Puerto Rico
Countries
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Other Identifiers
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10079
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG A5126
Identifier Type: -
Identifier Source: secondary_id
AACTG A5126
Identifier Type: -
Identifier Source: secondary_id
A5126
Identifier Type: -
Identifier Source: org_study_id