Back to resultsNelfinavir and M8 Drug-level Monitoring in HIV-1 Infection
Primary Purpose
HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nelfinavir
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV
Eligibility Criteria
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
Sites / Locations
- University of Wisconsin Hospital and Clinics
Outcomes
Primary Outcome Measures
Virologic response
Nelfinavir pharmacokinetics
Secondary Outcome Measures
Impact of nelfinavir and M8 pharmacokinetics on virologic response
Full Information
NCT ID
NCT00205283
First Posted
September 13, 2005
Last Updated
March 20, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
Agouron Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00205283
Brief Title
Nelfinavir and M8 Drug-level Monitoring in HIV-1 Infection
Official Title
Nelfinavir and M8 Drug-level Monitoring in HIV-1 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
August 1, 2005 (Actual)
Study Completion Date
August 1, 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Agouron Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Nelfinavir
Primary Outcome Measure Information:
Title
Virologic response
Title
Nelfinavir pharmacokinetics
Secondary Outcome Measure Information:
Title
Impact of nelfinavir and M8 pharmacokinetics on virologic response
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Urban, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Nelfinavir and M8 Drug-level Monitoring in HIV-1 Infection
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