SNPMiner Trials by Shray Alag


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Report for Clinical Trial NCT00294372

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Randomised, Double-blind, Placebo-controlled 7 Day Monotherapy Phase IIa Study to Evaluate the Antiviral Activity and Safety of Increasing Doses of Oral Administered RTV-boosted BILR 355 BS (75 mg and 150 mg Twice Daily) in HIV-1-infected, NNRTI-experienced Patients, Followed by 28 Day Combination Therapy With Tipranavir or Lopinavir Based HAART-regimen

The general aim is to evaluate the antiviral activity and safety of increasing doses of oral administered RTV-boosted BILR 355 BS (75 mg and 150 mg twice daily) in HIV-1-infected, NNRTI-experienced patients, followed by 28 day combination therapy with Tipranavir or Lopinavir based HAART-regimen

NCT00294372 HIV Infections
MeSH: HIV Infections

2 Interventions

Name: BILR 355 BS

Type: Drug

Name: Placebo

Type: Drug


Primary Outcomes

Measure: The primary endpoint will be reduction in plasma HIV-1 RNA from baseline to day 8, expressed in log10 copies/mm3.

Time: day 8

Secondary Outcomes

Measure: Virologic response at Day 8 and Day 35 using <400 copies/mL and 0.5, 1 and 1.5 log10 reduction in viral load from baseline

Time: up to week 5

Measure: Change from baseline in viral load at each visit

Time: up to week 9

Measure: Change from baseline in CD4+ cell counts at each visit

Time: up to week 9

Measure: Time averaged change from baseline in viral load through Days 8 and 35

Time: up to week 5

Measure: Number of reverse transcriptase (RT) mutations at baseline

Time: up to week 5

Measure: Number of NNRTI resistance-associated mutations at baseline (refer to Appendix 10.4)

Time: up to week 5

Measure: The presence of specific RT mutations (both in the list of NNRTI mutations and not in the list for exploratory purposes) at baseline

Time: up to week 5

Measure: The inhibitory quotient and minimum measured concentration of the analyte in plasma (Cmin)

Time: up to Day 8

Measure: Exploration of mutations that emerge with exposure to BILR 355 BS to determine the effect on both viral load and IC50 fold change from reference

Time: up to week 5

Measure: Area under the concentration-time curve of the analyte in plasma over the time interval 0 to 12 hours post-dose (AUC0-12h)

Time: up to week 5

Measure: Maximum measured concentration of the analyte in plasma (Cmax)

Time: up to week 5

Measure: Changes in total cholesterol, LDL, HDL and triglycerides from baseline to days 8 and 35

Time: up to week 9

Measure: Incidence of rash, hepatic events, and CNS adverse events

Time: up to week 9

Measure: Incidence of any adverse events (treatment related and unrelated)

Time: up to week 9

Measure: Incidence of laboratory test abnormalities

Time: up to week 9

Measure: Incidence of serious adverse events (including AIDS-defining events)

Time: up to week 9

Measure: Incidence of ≥ DAIDS 2 Grade elevation in ALT/AST

Time: up to week 9

Measure: Incidence of AEs leading to discontinuation from the study

Time: up to week 9

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 V106A

The following resistance mutations demonstrated at any time prior to starting trial therapy: V106A and/or Y188L 2. Female patients of child-bearing potential who: have a positive serum pregnancy test at screening or during the study, are breast feeding, are planning to become pregnant, are not willing to use a barrier method of contraception. --- V106A ---


2 Y188L

The following resistance mutations demonstrated at any time prior to starting trial therapy: V106A and/or Y188L 2. Female patients of child-bearing potential who: have a positive serum pregnancy test at screening or during the study, are breast feeding, are planning to become pregnant, are not willing to use a barrier method of contraception. --- V106A --- --- Y188L ---



HPO Nodes