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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2005-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Nelfinavir

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No