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Study of the 48-Week Virologic and Immunologic Response to Lopinavir/Ritonavir (Kaletra) in HIV Positive Adult Patients

HIV Infections Clinical Trial

Official title:
A Phase II, Open Label, Single Arm Study of the 48-Week Virologic and Immunologic Response to Lopinavir/Ritonavir (Kaletra) as a Single Agent in a Cohort of HIV Positive Adult Patients

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00116636
Study type Interventional
Source Therapeutic Concepts
Contact
Status Completed
Phase Phase 2
Start date June 2005
Completion date December 2007
View Details
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