SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT00116636

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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

NCT00116636 HIV Infections
MeSH:HIV Infections HIV Seropositivity

1 Interventions

Name: Kaletra

Type: Drug


Primary Outcomes

Measure: Proportion of patients with plasma HIV-1 RNA <400 copies/mL at Week 24 and 48

Measure: Proportion of patients with plasma HIV-1 RNA < 50 copies/mL at Week 48

Secondary Outcomes

Measure: Proportion of patients with plasma HIV-1 RNA <400 copies/mL or <50 copies/mL at each study visit

Measure: Proportion of patients with plasma HIV-1 RNA <50 copies/mL at Weeks 24 and 48 Weeks

Measure: Number of weeks until HIV RNA <400 copies/mL and <50 copies/mL, respectively

Measure: Change from baseline to each study visit in plasma HIV-1 RNA and CD4+ cell count

Measure: Time-averaged change from baseline to Weeks 12, 24 and 48 (AUCMB) in plasma HIV-1 RNA and CD4+cell count

Measure: Change in HIV genotype and phenotype in patients who either intensify study therapy or experience virologic rebound

Measure: HIV genomic sequence in treatment failures

Measure: Adverse events and treatment-limiting toxicities at all time points

Measure: Baseline and on-therapy assessment of clinical laboratory parameters

Measure: Change from baseline over time in clinical laboratory parameters including fasted triglycerides, total cholesterol, direct HDL cholesterol and LDL cholesterol

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment


There are 2 SNPs

SNPs


1 K65R

- Patient has an M184V mutation in reverse transcriptase, or mutations at 10, 20, 32, 46, 47, 48, 50, 54, 71, 73, 82, 84, or 90; - K65R mutation or 2 or more TAMs at baseline - History of active substance abuse, excluding cannabis, or psychiatric illness that, in the opinion of the investigator, would preclude compliance with protocol, dosing schedule and assessments. --- M184V --- --- K65R ---


2 M184V

- Patient has an M184V mutation in reverse transcriptase, or mutations at 10, 20, 32, 46, 47, 48, 50, 54, 71, 73, 82, 84, or 90; - K65R mutation or 2 or more TAMs at baseline - History of active substance abuse, excluding cannabis, or psychiatric illness that, in the opinion of the investigator, would preclude compliance with protocol, dosing schedule and assessments. --- M184V ---



HPO Nodes