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Report for Clinical Trial NCT00379405

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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
MeSH:HIV Infections

1 Interventions

Name: Saquinavir/Ritonavir : 2 capsules (500 mg) / 12 hours

Description: Saquinavir/Ritonavir: 2 capsules (500 mg) / 12 hours
Type: Drug
Group Labels: 1

A


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

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 9 SNPs

SNPs


1 A71T

- 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 ---


2 I54L

- 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 ---


3 I84A

- 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 --- --- V82A --- --- I84A ---


4 K20M

- 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 ---


5 L10F

- 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 ---


6 L63P

- 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 ---


7 L90M

- 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 --- --- V82A --- --- I84A --- --- L90M ---


8 M36I

- 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 ---


9 V82A

- 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 --- --- V82A ---



HPO Nodes