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Fostemsavir in Heavily Treatment Experienced Subjects Infected With Multi-drug Resistant HIV-1
NCT02362503Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Feb 2015
- Primary completion
- Aug 2016
- Countries
- 25
- Sponsor
- ViiV Healthcare
- Modality
- Small Molecules
- Drugs
- fostemsavir
- Conditions
- human immunodeficiency virus type 1 infection (HIV-1)
01
Overview
Phase 3, randomised, double-blind trial of fostemsavir in human immunodeficiency virus type 1 infection (HIV-1) (3 arms), sponsored by ViiV Healthcare. Primary endpoint: Mean Change in Logarithm to the Base 10 (log10) HIV-1 Ribonucleic Acid (RNA) at 8 days. Started Feb 2015; status: active, not recruiting.
02
Design
3 arms- Study design
- RandomizedDouble-blind
A1: BMS-663068
Phase 1: BMS-663068 600 mg tablets orally twice daily for 8 days. Phase 2: BMS-663068 600 mg tablets orally twice daily for 48 weeks or longer.
B1: Placebo + BMS-663068
Phase 1: Placebo twice daily for 8 days. Phase 2: BMS-663068 600 mg tablets orally twice daily for 48 weeks or longer.
BMS-663068
BMS-663068 600 mg tablets orally twice daily for 48 weeks or longer (Non-Randomized Cohort).
03
Who it enrols
Men and non-pregnant women with chronic HIV-1 infection, heavily treatment-experienced with multi-drug resistance, failing current regimen with HIV-1 RNA >= 400 c/mL.
04
Endpoints
Primary
Mean Change in Logarithm to the Base 10 (log10) HIV-1 Ribonucleic Acid (RNA)
Secondary
Percentage of Participants With HIV-1 RNA Decreases From Day 1 That Exceed 0.5 log10 c/mL and 1.0 log10 c/mL
Percentage of Participants With HIV-1 RNA <40 c/mL
Number of Participants With On-treatment Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)
Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline
Number of Participants With Toxicity Grade Increase in Hematology Results to Grade 3-4 Relative to Baseline
Number of Participants With Centers for Disease Control (CDC) Class C Events
Change From Day 1 in Cluster of Differentiation (CD) 4+ T-cell Count
Change in CD4+ T- Cell Count Percentage
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