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 HIV Infections 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 48Secondary Outcomes
Measure: CD4 and CD8 lymphocyte count. Time: weeks 24 and 48Measure: 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