SNPMiner Trials by Shray Alag

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SNPMiner SNPMiner Trials (Home Page)


Report for Mutation A71T

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There is one clinical trial.

Clinical Trials


1 Open-label, Comparative and Randomised Pilot Study to Evaluate the Efficacy and Safety of Saquinavir/Ritonavir in Single Therapy vs Standard HAART Therapy as Maintenance Therapy.

Study the efficacy of Saquinavir/Ritonavir when given in single therapy as maintenance therapy, compared to standard HAART therapies.

NCT00379405
Conditions
  1. HIV Infections
Interventions
  1. Drug: Saquinavir/Ritonavir : 2 capsules (500 mg) / 12 hours
MeSH:HIV Infections

- Documented existence of any of the primary mutations in the protease gene or 3 or more of the following: L10F/I/R/V, K20M/R, M36I/V, I54L/T/V, L63P, A71T/V , V82A/F/T/S, I84A/V OR L90M. --- L10F --- --- K20M --- --- M36I --- --- I54L --- --- L63P --- --- A71T ---

Primary Outcomes

Measure: Virological response: Viral Load

Time: weeks 24 and 48

Secondary Outcomes

Measure: CD4 and CD8 lymphocyte count.

Time: weeks 24 and 48

Measure: Physical Exploration: including weight, height, index waist/hip (the abdominal perimeter is measured between the last floating rib and the iliac crest), assessment of changes in body fat distribution,...

Time: weeks 24 and 48

Measure: Karnofsky Index.

Time: weeks 24 and 48

Measure: Adverse events.

Time: during the 48 weeks of follow-up

Measure: Trough plasma concentrations of Saquinavir.

Time: during the 48 weeks of follow-up

Measure: Lipid study in plasma (total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides)

Time: during the 48 weeks of follow-up

Measure: Serology for Hepatitis B and C virus.

Time: at baseline visit

Measure: Assessment of treatment adherence.

Time: at baseline and weeks 4, 12, 24, 36 and 48

Measure: Assessment of quality of life (by means of the MOS-HIV questionnaire).

Time: at baseline and weeks 4, 12, 24, 36 and 48

Measure: Genotype if virological failure.

Time: at any time of study if it is necessary


HPO Nodes