Study of the 48-Week Virologic and Immunologic Response to Lopinavir/Ritonavir (Kaletra) in HIV Positive Adult Patients
Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
Participant gender:
Summary
Expected Enrollment: 40 patients
Study Start Date: June 2005
Study Objectives:
- To conduct a pilot study to assess the safety, tolerability, and antiviral activity of
Kaletra 400/100 mg taken twice a day (bid) in antiretroviral (ARV)-naïve HIV-infected
patients at Week 48
Primary Objectives:
- To determine the proportion of patients with HIV RNA <400 copies/mL at weeks 24 and 48
- To determine the proportion of patients with HIV RNA < 50 at weeks 24 and 48
- To elucidate the specific adverse event (AE) profile of Kaletra single agent therapy
Secondary Objectives:
- To assess the proportion of patients below the limit of quantification (LOQ) at each
visit. Patients will be observed at baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36,
40, 44 and 48.
- To determine the time to HIV RNA reaching <400 and <50 copies/mL
- To determine the time to virologic failure
- To assess change from baseline at each visit for HIV RNA and CD4 count at weeks 4, 8,
12, 24 and 48.
- To assess changes in genotype from baseline to time of confirmed virologic failure (2
consecutive HIV RNA measurements >400 copies/mL after suppressing to <400 copies/mL) or
at time of treatment intensification.
- To characterize changes in lipid and triglyceride concentrations over time and the
effect of treatment with appropriate drugs (fibrate or statin, if necessary) on these
elevations.
- To evaluate the safety and tolerability of subjects through 48 weeks of drug exposure.
- To describe virologic response following intensification in Kaletra single agent
virologic failures