Nelfinavir and M8 Drug-Level Monitoring in HIV-1 Infection
The purpose of this study is to assess the impact of prospective drug level monitoring and dose-adjustment of nelfinavir (NFV) on the clinical and virologic outcomes in a group of HIV-infected patients who have achieved virologic success while receiving a nelfinavir containing highly active antiretroviral therapy (HAART) regimen...
Brief Summary
Official Title: “Nelfinavir and M8 Drug-Level Monitoring in HIV-1 Infection”
The purpose of this study is to assess the impact of prospective drug level monitoring and dose-adjustment of nelfinavir (NFV) on the clinical and virologic outcomes in a group of HIV-infected patients who have achieved virologic success while receiving a nelfinavir containing highly active antiretroviral therapy (HAART) regimen.
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Nelfinavir
Outcome Measures for this Clinical Trial
Primary Measures
- Virologic response
- Nelfinavir pharmacokinetics
Secondary Measures
- Impact of nelfinavir and M8 pharmacokinetics on virologic response
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Clinical Trial Investigator Information
Lead Investigator: University of Wisconsin, Madison Other
Overall Clinical Trial Officials and Contacts
Andrew Urban, MD Principal Investigator University of Wisconsin Hospital and Clinics
Overall Contact: Andrew Urban, MD 608-256-1901 andrew.urban@med.va.gov
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00205283
Study ID Number: 2002-212
ClinicalTrials.gov Identifier: NCT00205283
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00205283
