Study of the 48-Week Virologic and Immunologic Response to Lopinavir/Ritonavir (Kaletra) in HIV Positive Adult Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2005 by Therapeutic Concepts.
Recruitment status was Recruiting
Recruitment status was Recruiting
Information provided by:
First received: June 29, 2005
Last updated: July 18, 2005
Last verified: June 2005
Expected Enrollment: 40 patients
Study Start Date: June 2005
- 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
- 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
- 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
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Therapeutic Concepts:
Primary Outcome Measures:
- Proportion of patients with plasma HIV-1 RNA <400 copies/mL at Week 24 and 48
- Proportion of patients with plasma HIV-1 RNA < 50 copies/mL at Week 48
Secondary Outcome Measures:
- Proportion of patients with plasma HIV-1 RNA <400 copies/mL or <50 copies/mL at each study visit
- Proportion of patients with plasma HIV-1 RNA <50 copies/mL at Weeks 24 and 48 Weeks
- Number of weeks until HIV RNA <400 copies/mL and <50 copies/mL, respectively
- Change from baseline to each study visit in plasma HIV-1 RNA and CD4+ cell count
- Time-averaged change from baseline to Weeks 12, 24 and 48 (AUCMB) in plasma HIV-1 RNA and CD4+cell count
- Change in HIV genotype and phenotype in patients who either intensify study therapy or experience virologic rebound
- HIV genomic sequence in treatment failures
- Adverse events and treatment-limiting toxicities at all time points
- Baseline and on-therapy assessment of clinical laboratory parameters
- Change from baseline over time in clinical laboratory parameters including fasted triglycerides, total cholesterol, direct HDL cholesterol and LDL cholesterol
|Study Start Date:||June 2005|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116636
|Contact: Joseph C. Gathe, M.D.||firstname.lastname@example.org|
|Contact: Deborah H. Lemons, B.S.||713-526-9821 ext email@example.com|
|United States, Texas|
|Therapeutic Concepts, P.A.||Recruiting|
|Houston, Texas, United States, 77004|
|Contact: Joseph C. Gathe, M.D. 713-526-9821 firstname.lastname@example.org|
|Contact: Deborah H. Lemons, B.S. 713-526-9821 email@example.com|
|Principal Investigator: Joseph C. Gathe, M.D.|
Sponsors and Collaborators
|Principal Investigator:||Joseph C. Gathe, M.D.||Therapeutic Concepts, P.A.|