SNPMiner Trials by Shray Alag
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SNPMiner Trials (Home Page)
Report for Mutation L33I
Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene
There are 2 clinical trials
Clinical Trials
1 Once-daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl. A Prospective, Randomized, Multicentre, Open Clinical Study.
There are few randomized clinical trials in advanced HIV patients. This is a multicenter, randomized, open clinical trial, comparing three parallel groups, to compare the immunological reconstitution and the virological efficacy and safety of three different combinations of antiretroviral therapy given once a day (QD): tenofovir plus emtricitabine plus either efavirenz, lopinavir-ritonavir or atazanavir-ritonavir during 96 weeks in advanced antiretroviral naïve HIV-1 infected patients with less than 100 CD4+ T-cells/mm3. Primary endpoint is the median increase in CD4+ T-cell count at 48 weeks after starting HAART.
NCT00532168
Conditions
- HIV Infections
Interventions
- Drug: tenofovir + emtricitabine + efavirenz
- Drug: tenofovir + emtricitabine + lopinavir-ritonavir
- Drug: tenofovir + emtricitabine + atazanavir-ritonavir
MeSH:HIV Infections
- No mutations of drug resistance at baseline (M184V/I, K65R, resistance to efavirenz or 2 or more PRAMs (L33I/F/V, V82A/F/L/T, I84V, L90M) - Written informed consent Exclusion Criteria: - Hypersensibility to study drugs. --- M184V --- --- K65R --- --- L33I ---
Primary Outcomes
Measure: Median increase in CD4+ T-cell count at 48 weeks after starting the HAART combination randomly assigned Time: 48 weeks2 Preservation and Expansion of T-cell Subsets Following HAART De-intensification to Atazanavir/Ritonavir (ATV/r) in Adolescents With CD4 + T Cells > 350 Cells/mm3 Initiating HAART
This study proposes to evaluate a pre-DHHS guideline of HAART initiation and then de-intensification management strategy in adolescents with mild immunosuppression and compare changes in CD4% from baseline to week 48 and then during de-intensification.
NCT00491556
Conditions
- HIV Infections
Interventions
- Procedure: Early Initiation of Highly Active Anti-Retroviral Therapy
- Procedure: Standard Care
MeSH:HIV Infections
The following genotypic mutations exclude subjects from participation in ATN 061: Major ATV mutations I50L; I84V; N88D/S, Major PI mutations including: D30N; V32I; L33I/F/V; M46I/L; I47V/A; G48V; I50V/L; I54V/L/A/M/T/S; L76V; V82A/F/T/S/L; L90M, Any major PI mutation as defined by the most current IAS-USA Drug Resistance Mutations Figures that would adversely affect a subject's future PI choices, Major RT mutations: Q151M and 69 insertion complex; Decisions regarding the selection of an NRTI backbone for subjects with NRTI resistance mutations other than those described above will be made by the site PI in consultation with the protocol chair or his designee. --- I50L --- --- I84V --- --- N88D --- --- D30N --- --- V32I --- --- L33I ---
Primary Outcomes
Measure: Difference in CD4+ T Cell Percentage Between Week 0 and Week 48 Time: Week 0 and Week 48Measure: Difference in CD4+ T Cell Percentage Between Week 48 and Week 152 Time: 152 Weeks
Secondary Outcomes
Measure: Difference in CD4+ T Cell Count Between Week 0 and Week 48 Time: 48 weeksMeasure: Difference in CD4+ T Cell Count Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD4+ Naïve T Cell Count Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD4+ Naïve T Cell Count Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD4+ Termed Central Memory (TCM) Count Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD4+ TCM Count Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD4+ Effector Memory (TEM)Ro Count Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD4+ TEMRo Count Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD4+ TEMRa Count Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD4+ TEMRa Count Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8+ Naïve T-Cell Count Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8+ Naïve T-Cell Count Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8+ TCM Count Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8+ TCM Count Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8+ TEMRo Count Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8+ TEMRo Count Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8+ TEMRa Count Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8+ TEMRa Count Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 Naïve CD28 Cell Percentage Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 Naïve CD28 Cell Percentage Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 Naïve CD38 Cell Percentage Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 Naïve CD38 Cell Percentage Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 Naïve CD57 Cell Percentage Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 Naïve CD57 Cell Percentage Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 Naïve T-Cell Percentage Expressing Human Leukocyte Antigen-D Related (HLA-DR) Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 Naïve T-Cell Percentage Expressing HLA-DR Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 TCM CD28 Percentage Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 TCM CD28 Percentage Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 TCM CD38 Percentage Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 TCM CD38 Percentage Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 TCM CD57 Percentage Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 TCM CD57 Percentage Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 TCM HLA-DR Percentage Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 TCM HLA-DR Percentage Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 TEMRo CD28 Percentage Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 TEMRo CD28 Percentage Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 TEMRo CD38 Percentage Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 TEMRo CD38 Percentage Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 TEMRo CD57 Percentage Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 TEMRo CD57 Percentage Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 TEMRO HLADR Percentage Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 TEMRo HLA-DR Percentage Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 TEMRa CD28 Percentage Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 TEMRa CD28 Percentage Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 TEMRa CD38 Percentage Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 TEMRa CD38 Percentage Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 TEMRa CD57 Percentage Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 TEMRa CD57 Percentage Between Week 48 and Week 152 Time: 152 weeks
Measure: Difference in CD8 TEMRa HLA-DR Percentage Between Week 0 and Week 48 Time: 48 weeks
Measure: Difference in CD8 TEMRa HLA-DR Percentage Between Week 48 and Week 152 Time: 152 weeks