Clinical Trials

MainTitle

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

This study has been completed
Sponsor
University of Wisconsin, Madison

Collaborator
Agouron Pharmaceuticals

Information provided by (Responsible Party)
University of Wisconsin, Madison
ClinicalTrials.gov Identifier
NCT00205283

First received: September 13, 2005
Last updated: March 20, 2019
Last Verified: March 2019
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV Infections

Drug : Nelfinavir

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nelfinavir and M8 Drug-level Monitoring in HIV-1 Infection

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures

  • Virologic response
  • Nelfinavir pharmacokinetics
Secondary Outcome Measures:
  • Impact of nelfinavir and M8 pharmacokinetics on virologic response

Enrollment: 20
Study Start Date: August 2003
Study Completion Date: August 1, 2005
Primary Completion Date: August 1, 2005 (Final data collection date for primary outcome measure)

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205283

Locations

United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison
Agouron Pharmaceuticals

Investigators

Principal Investigator: Andrew Urban, MD University of Wisconsin, Madison
More Information

More Information


Responsible Party: University of Wisconsin, Madison  
ClinicalTrials.gov Identifier: NCT00205283   History of Changes  
Other Study ID Numbers: 2002-212  
Study First Received: September 13, 2005  
Last Updated: March 20, 2019  

Keywords provided by University of Wisconsin, Madison:

HIV

Additional relevant MeSH terms:
Infection
Communicable Diseases
Nelfinavir

ClinicalTrials.gov processed this data on September 16, 2019
This information is provided by ClinicalTrials.gov.