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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by University of Wisconsin, Madison.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00205283
First Posted: September 20, 2005
Last Update Posted: October 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Agouron Pharmaceuticals
Information provided by (Responsible Party):
University of Wisconsin, Madison
  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

Resource links provided by NLM:


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

Estimated Enrollment: 20
Study Start Date: August 2003
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00205283


Contacts
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

Locations
United States, Wisconsin
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Andrew Urban, MD    608-256-1901 ext 17472    andrew.urban@med.va.gov   
Sponsors and Collaborators
University of Wisconsin, Madison
Agouron Pharmaceuticals
Investigators
Principal Investigator: Andrew Urban, MD University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00205283     History of Changes
Other Study ID Numbers: 2002-212
First Submitted: September 13, 2005
First Posted: September 20, 2005
Last Update Posted: October 5, 2015
Last Verified: September 2005

Keywords provided by University of Wisconsin, Madison:
HIV

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Nelfinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents