Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success With Nelfinavir
NCT ID: NCT00002220
Last Updated: 2005-06-24
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
PHASE3
120 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Indinavir sulfate
Efavirenz
Levocarnitine
Adefovir dipivoxil
Eligibility Criteria
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Inclusion Criteria
* Serologically documented HIV infection.
* Baseline CD4 count greater than or equal to 50 cells and vRNA greater than or equal to 10,000 copies/ml.
* Parental consent for patients under 18.
Nelfinavir-Failure Group:
* Must have protease inhibitor experience solely with nelfinavir and be considered drug-adherent.
* Must be candidate for changing therapy because of virologic failure and be receiving nelfinavir at entry (at least 16 weeks of nelfinavir plus NRTI therapy with at least a 10-fold decline in vRNA due to nelfinavir therapy and a subsequent increase toward the patient's baseline vRNA of at least 10-fold).
Control Group:
* Must have received any combination of currently licensed nucleoside reverse transcriptase inhibitors for at least 16 weeks.
* Must be naive to efavirenz, adefovir dipivoxil, and other NRTI's.
Exclusion Criteria
Excluded:
Control group:
* Prior efavirenz, adefovir dipivoxil, or other non-nucleoside reverse transcriptase inhibitors.
Required:
Nelfinavir-failure patients:
* At least 16 weeks of nelfinavir.
Control group:
* At least 16 weeks of any combination of currently licensed nucleoside reverse transcriptase inhibitors.
16 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Locations
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LAC / USC Med Ctr / Infectious Diseases
Los Angeles, California, United States
Yale Univ / AIDS Clinical Trials Unit
New Haven, Connecticut, United States
Med Ctr of Delaware
Wilmington, Delaware, United States
Hawaii AIDS Clinical Trial Unit
Honolulu, Hawaii, United States
Rush Presbyterian Saint Lukes Med Ctr
Chicago, Illinois, United States
Johns Hopkins Hosp
Baltimore, Maryland, United States
Massachusetts Gen Hosp
Boston, Massachusetts, United States
Columbia Presbyterian Hosp
New York, New York, United States
AIDS TMT Unit / Univ Hosp
Stony Brook, New York, United States
Vanderbilt Clinic
Nashville, Tennessee, United States
Oaklawn Physicians Group
Dallas, Texas, United States
Countries
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Other Identifiers
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075-00
Identifier Type: -
Identifier Source: secondary_id
246N
Identifier Type: -
Identifier Source: org_study_id
NCT00002242
Identifier Type: -
Identifier Source: nct_alias