HIV Infections
Conditions
Keywords
HIV
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.
Interventions
DRUGNelfinavir
Sponsors
Agouron Pharmaceuticals
University of Wisconsin, Madison
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Virologic response | — |
| Nelfinavir pharmacokinetics | — |
Secondary
| Measure | Time frame |
|---|---|
| Impact of nelfinavir and M8 pharmacokinetics on virologic response | — |
Countries
United States
Outcome results
None listed