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Report for Clinical Trial NCT01045369

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase IV 48 Week, Open Label, Pilot Study of Kaletra and Intelence Tablets in Naive Subjects

The purpose of this study is to see if using a combination of other drug classes, like the ones that Kaletra® and Intelence™ belong to, can still help reduce the amount of HIV in your blood. Using Kaletra® and Intelence™ without other drugs is not approved by the FDA and so their use in this study is experimental.

NCT01045369 HIV Infections
MeSH:HIV Infections

1 Interventions

Name: Kaletra and Intelence Tablets

Description: Kaletra 400 mg twice a day and Intelence Tablets 200mg twice a day.
Type: Drug
Group Labels: 1

Kaletra And Intelence


Primary Outcomes

Measure: Proportion of patients with plasma HIV-1 RNA < 400 copies/mL at weeks 24 and 48

Time: At weeks 24 and 48

Measure: Proportion of patients with plasma HIV-1 RNA < 75 copies/mL at weeks 24 and 48

Time: At weeks 24 and 48

Secondary Outcomes

Measure: Proportion of patients with plasma HIV-1 RNA < 400 copies/mL or < 75 copies/mL at each study visit

Time: At weeks 24 and 48

Measure: Number of weeks until HIV RNA < 400 copies/mL and < 75 copies/mL, respectively

Time: At weeks 24 and 48

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment


There are 3 SNPs

SNPs


1 I47A

(See Appendix D) - Patient has >3 mutations at 10, 20, 24, 32, 33, 36, 46, 47, 48, 50, 54, 73, 82, 84, or 90 in protease or ≥1 of the following mutations in protease (I47A/V, V32I, or L76V). --- I47A ---


2 L76V

(See Appendix D) - Patient has >3 mutations at 10, 20, 24, 32, 33, 36, 46, 47, 48, 50, 54, 73, 82, 84, or 90 in protease or ≥1 of the following mutations in protease (I47A/V, V32I, or L76V). --- I47A --- --- V32I --- --- L76V ---


3 V32I

(See Appendix D) - Patient has >3 mutations at 10, 20, 24, 32, 33, 36, 46, 47, 48, 50, 54, 73, 82, 84, or 90 in protease or ≥1 of the following mutations in protease (I47A/V, V32I, or L76V). --- I47A --- --- V32I ---



HPO Nodes