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Report for Clinical Trial NCT00294372
Developed by Shray Alag, 2020.
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 ---
HPO Nodes