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

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. Identifier: NCT00205283
Recruitment Status : Unknown
Verified September 2005 by University of Wisconsin, Madison.
Recruitment status was:  Recruiting
First Posted : September 20, 2005
Last Update Posted : October 5, 2015
Agouron Pharmaceuticals
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Nelfinavir Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Study Start Date : August 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Primary Outcome Measures :
  1. Virologic response
  2. Nelfinavir pharmacokinetics

Secondary Outcome Measures :
  1. Impact of nelfinavir and M8 pharmacokinetics on virologic response

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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

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 identifier (NCT number): NCT00205283

Contact: Andrew Urban, MD 608-256-1901 ext 17472
Contact: Frank Graziano, MD, PhD 608-263-6186

United States, Wisconsin
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Andrew Urban, MD    608-256-1901 ext 17472   
Sponsors and Collaborators
University of Wisconsin, Madison
Agouron Pharmaceuticals
Principal Investigator: Andrew Urban, MD University of Wisconsin, Madison

Responsible Party: University of Wisconsin, Madison Identifier: NCT00205283     History of Changes
Other Study ID Numbers: 2002-212
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: October 5, 2015
Last Verified: September 2005

Keywords provided by University of Wisconsin, Madison:

Additional relevant MeSH terms:
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
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents