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Report for Clinical Trial NCT00294372
Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene
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
2 Interventions
Name: BILR 355 BS
Name: Placebo
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
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 ---
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 ---