Heavily Treatment Experienced Subjects Infected with Multi-drug Resistant (MDR) HIV-1
Conditions
Brief summary
The efficacy of fostemsavir, relative to placebo, is assessed using the mean change in log10 HIV-1 RNA from Day 1 at Day 8 as determined by ANCOVA in the randomized cohort.
Detailed description
•Proportions of subjects in the randomized cohort with HIV-1 RNA decreases •Durability of response at Weeks 24, 48, and 96 of OBT. •Frequency of SAEs, AEs leading to discontinuation, and Grade 3-4 laboratory abnormalities during OBT. •Disease progression during OBT. •Drug resistance testing •Changes in CD4+ T-cells counts and percentages, for Fostemsavir and placebo. •Changes from baseline in HIV-1 RNA, CD4+ cell counts, and percentage of CD4+ T-cells, for Fostemsavir when given with OBT.
Interventions
Sponsors
Viiv Healthcare UK Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy of fostemsavir, relative to placebo, is assessed using the mean change in log10 HIV-1 RNA from Day 1 at Day 8 as determined by ANCOVA in the randomized cohort. | — |
Secondary
| Measure | Time frame |
|---|---|
| •Proportions of subjects in the randomized cohort with HIV-1 RNA decreases •Durability of response at Weeks 24, 48, and 96 of OBT. •Frequency of SAEs, AEs leading to discontinuation, and Grade 3-4 laboratory abnormalities during OBT. •Disease progression during OBT. •Drug resistance testing •Changes in CD4+ T-cells counts and percentages, for Fostemsavir and placebo. •Changes from baseline in HIV-1 RNA, CD4+ cell counts, and percentage of CD4+ T-cells, for Fostemsavir when given with OBT. | — |
Countries
Romania
Outcome results
None listed