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

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Completed
• CT.gov ID: NCT00205283
• Collaborator: Agouron Pharmaceuticals (Industry)
• Enrollment: 20
• Location: 1
• Duration (Months): 24
• Patients Per Site Per Month: 0.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Nelfinavir	N/A

Study Design

• Study Type: Interventional
• Actual 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: Aug 1, 2003
• Actual Primary Completion Date: Aug 1, 2005
• Actual Study Completion Date: Aug 1, 2005

Outcome Measures

Primary Outcome Measures

1. Virologic response []

2. Nelfinavir pharmacokinetics []

Secondary Outcome Measures

1. Impact of nelfinavir and M8 pharmacokinetics on virologic response []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT00205283
• Other Study ID Numbers: 2002-212
• First Posted: Sep 20, 2005
• Last Update Posted: Mar 22, 2019
• Last Verified: Mar 1, 2019

• Keywords provided by University of Wisconsin, Madison: HIV
• Additional relevant MeSH terms: Infections; Communicable Diseases; Nelfinavir

Study Results

No Results Posted as of Mar 22, 2019