SNPMiner Trials by Shray Alag


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Report for Mutation E44D

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There is one clinical trial.

Clinical Trials


1 Open-Label, Single-Centre, Randomised Pilot Study to Evaluate Immunovirological and Clinical Evolution of a Combination With Nucleoside Analogues/Nucleotides (Trizivir +Tenofovir) in Multiresistant Patients With Virological Failure

To evaluate whether the combined therapy of two nucleosides plus one nucleotide (Trizivir + TDF) manages to keep CD4 lymphocytes stable in patients with HIV infection on antiretroviral treatment that present virological failure and multiple resistance to antiretrovirals.

NCT00356616 HIV Infections Drug: Trizivir (AZT+3HT+Abacavir) twice daily Drug: Viread (300 mg Tenofovir disoproxil fumarate) once daily
MeSH: HIV Infections

5. Genotype or phenotype resistance to three families of antiretrovirals (PI, NTRI and NNRTI) demonstrated in genotype study carried out in the last 48 weeks and defined as: - 3 or more TAMS of the following: M41L, E44D, D67N, V118I, L210W, T215Y/F, K219Q/E. --- M41L --- --- E44D ---

Primary Outcomes

Measure: Variations in the immune status of patients in each group throughout follow-up.

Time: 48 weeks

Secondary Outcomes

Measure: Percentage of patients that increase viral load by > 0.5 log

Time: weeks 12, 24, 36 and 48

Measure: Percentage of patients that increase viral load by > 100,000 copies/mL

Time: weeks 12, 24, 36 and 48

Measure: Percentage of patients that present some clinical event, B or C classification according to the CDC.

Time: during the 48 weeks of follow-up

Measure: Percentage of patients that present clinical or analytical adverse effects degree > 2 according to the WHO classification.

Time: weeks 12, 24, 36 and 48

Measure: Percentage of patients that drop out of treatment.

Time: weeks 12, 24, 36 and 48

Measure: Percentage of patients that drop out of the study due to intolerance or adverse effects.

Time: weeks 12, 24, 36 and 48

Measure: Percentage of change in lipid determinations.

Time: weeks 12, 24, 36 and 48 with regard to baseline

Measure: Percentage of patients that report changes, improvement or worsening in redistribution of body fat.

Time: weeks 12, 24, 36 and 48

Measure: Percentage of patients that present adherence to the antiretroviral treatment > 95%.

Time: weeks 12, 24, 36 and 48

Measure: Percentage of patients that present improvement in the quality of life (MOS-HIV) and satisfaction questionnaires.

Time: weeks 12, 24, 36 and 48

Measure: Percentage of patients that present an increase in the number of active drugs.

Time: at the end of the study


HPO Nodes