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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00205283 |
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Date of registration:
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13/09/2005 |
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Primary sponsor: |
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Public title:
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Nelfinavir and M8 Drug-Level Monitoring in HIV-1 Infection
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Scientific title:
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Nelfinavir and M8 Drug-Level Monitoring in HIV-1 Infection |
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Date of first enrolment:
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August 2003 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00205283 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Andrew Urban, MD |
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Address:
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Telephone:
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608-256-1901 |
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Email:
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andrew.urban@med.va.gov |
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Affiliation:
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Name:
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Andrew Urban, MD |
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Address:
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Telephone:
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608-256-1901 |
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Email:
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andrew.urban@med.va.gov |
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Affiliation:
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Name:
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Andrew Urban, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Wisconsin Hospital and Clinics |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Antiretroviral naive or currently taking a nelfinavir containing HAART regimen where
nelfinavir is the first protease inhibitor
- Patients willing to comply with the protocol
- Age greater than or equal to 18 years
- Virologically successful if already on an established regimen
Exclusion Criteria:
- Prior use of a protease inhibitor exclusive of nelfinavir
- Required use or concomitant use of drugs that may interact with or are
contraindicated with nelfinavir
- Use of immunomodulators or vaccines for HIV disease
- Intercurrent illness at the time of enrollment that, in the clinician's judgement,
could influence the HIV RNA concentration
- Baseline ALT levels greater than five times the upper limit of normal
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Intervention(s)
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Drug: Nelfinavir
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Primary Outcome(s)
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Nelfinavir pharmacokinetics
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Virologic response
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Secondary Outcome(s)
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Impact of nelfinavir and M8 pharmacokinetics on virologic response
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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