A randomized controlled trial of therapeutic drug monitoring in treatment-naive and -experienced HIV-1-infected patients.
J Acquir Immune Defic Syndr
; 46(4): 433-42, 2007 Dec 01.
Article
in En
| MEDLINE
| ID: mdl-17786128
ABSTRACT
OBJECTIVE:
To improve the utility of therapeutic drug monitoring (TDM) by defining the proportion of patients with and predictors of above or below target protease inhibitor (PI) or nonnucleoside reverse transcriptase inhibitor (NNRTI) concentrations.METHODS:
This 48-week, multicenter, open-label clinical trial randomized patients to TDM versus standard of care (SOC). Serial pharmacokinetics, including a week-2 3-sample sparse collection, and expert committee TDM recommendations were given to TDM-arm patients' providers.RESULTS:
Seventy-four (39%) of 190 patients had week-2 concentrations outside of targets and 122 (64%) of 190 had nontarget exposure at least once over 48 weeks. Providers accepted 75% of TDM recommendations. Among patients with below-target concentrations, more TDM-arm than SOC-arm patients achieved targets (65% vs. 45%; P = 0.09). Increased body weight and efavirenz or lopinavir/ritonavir use were significant predictors of nontarget concentrations. Patients at target and patients who achieved targets after TDM-directed dose modifications trended toward greater viral load reductions at week 48 than patients with below-target exposures (HIV RNA reductions 2.4, 2.3, and 1.9 log10 copies/mL, respectively; P = 0.09).CONCLUSIONS:
Most patients had nontarget PI and/or NNRTI concentrations over 48 weeks. TDM recommendations were well accepted and improved exposure. Patients below TDM targets trended toward worse virologic response.
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Collection:
01-internacional
Database:
MEDLINE
Main subject:
HIV Infections
/
Drug Monitoring
/
Anti-HIV Agents
Type of study:
Clinical_trials
/
Guideline
Limits:
Adult
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
J Acquir Immune Defic Syndr
Journal subject:
SINDROME DA IMUNODEFICIENCIA ADQUIRIDA (AIDS)
Year:
2007
Document type:
Article
Affiliation country:
Estados Unidos