Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Nelfinavir and M8 Drug-Level Monitoring in HIV-1 Infection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University of Wisconsin, Madison.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Agouron Pharmaceuticals
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00205283
First received: September 13, 2005
Last updated: October 29, 2007
Last verified: September 2005

September 13, 2005
October 29, 2007
August 2003
Not Provided
  • Virologic response
  • Nelfinavir pharmacokinetics
Same as current
Complete list of historical versions of study NCT00205283 on ClinicalTrials.gov Archive Site
Impact of nelfinavir and M8 pharmacokinetics on virologic response
Same as current
Not Provided
Not Provided
 
Nelfinavir and M8 Drug-Level Monitoring in HIV-1 Infection
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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Nelfinavir
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Not Provided
Not Provided

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
Both
18 Years and older
Not Provided
Contact: Andrew Urban, MD 608-256-1901 ext 17472 andrew.urban@med.va.gov
Contact: Frank Graziano, MD, PhD 608-263-6186 fmg@medicine.wisc.edu
United States
 
NCT00205283
2002-212
Not Provided
Not Provided
University of Wisconsin, Madison
Agouron Pharmaceuticals
Principal Investigator: Andrew Urban, MD University of Wisconsin Hospital and Clinics
University of Wisconsin, Madison
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP