Alternative Dosing Strategy for Anti-HIV Drugs

Completed · Phase 4

Conditions studied: HIV Infections

In brief

Anti-HIV drugs are usually given to patients at fixed, standardized doses. This study will investigate alternative ways of dosing anti-HIV drugs to improve viral control. Study hypothesis: The optimal dosage regimen required to obtain the maximum benefit from antiretroviral therapy is achieved with strategies that control for pharmacokinetic and pharmacodynamic variability among patients.

Key facts

Study ID

NCT00059384

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

66

Starts

2003-01-01

Expected to finish

2007-12-01

Last updated by the study team

2008-09-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Concurrent investigational antiretroviral agent
• Malignancy, including Kaposi's sarcoma, requiring systemic chemotherapy
• Active opportunistic infection requiring therapy within 14 days prior to study entry
• Drug-resistant mutations that necessitate a change in antiretroviral regimen
• Active drug or alcohol use or dependence
• Certain laboratory abnormalities
• Pregnant or breastfeeding
• Known nonadherence with medications and scheduled clinic visits
• Any medical condition that, in the opinion of the investigators, would preclude successful completion of the study

Where it is running

• University of Colorado Health Sciences Center — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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