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



Status:Completed
Conditions:Infectious Disease, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:August 2003
End Date:August 1, 2005

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Trial Summary
Trial Overview
Inclusion Criteria
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.


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
We found this trial at
1
site
University of Wisconsin Hospital and Clinics
600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
Phone: 608-256-1901
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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from
Madison, WI
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