HIV-1 Infection
Conditions
Brief summary
Percentage of participants with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) ≥50 copies/mL at Week 48, Percentage of participants experiencing ≥1 adverse event (AE) through Week 48, Percentage of participants discontinuing from study treatment due to an AE through Week 48
Detailed description
Percentage of participants with HIV-1 RNA <50 copies/mL at Week 96, Percentage of participants with HIV-1 RNA <200 copies/mL at Week 48, Percentage of participants with HIV-1 RNA <200 copies/mL at Week 96, Change from baseline in cluster of differentiation 4+ (CD4+) T-cells at Week 48, Change from baseline in CD4+ T-cells at Week 96, Incidence of viral drug resistance, Change from baseline in body weight at Week 48, Change from baseline in body weight at Week 96, Percentage of participants experiencing ≥1 AE through Week 96, Percentage of participants discontinuing from study treatment due to an AE through Week 48
Interventions
Sponsors
Merck Sharp & Dohme LLC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) ≥50 copies/mL at Week 48, Percentage of participants experiencing ≥1 adverse event (AE) through Week 48, Percentage of participants discontinuing from study treatment due to an AE through Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants with HIV-1 RNA <50 copies/mL at Week 96, Percentage of participants with HIV-1 RNA <200 copies/mL at Week 48, Percentage of participants with HIV-1 RNA <200 copies/mL at Week 96, Change from baseline in cluster of differentiation 4+ (CD4+) T-cells at Week 48, Change from baseline in CD4+ T-cells at Week 96, Incidence of viral drug resistance, Change from baseline in body weight at Week 48, Change from baseline in body weight at Week 96, Percentage of participants experiencing ≥1 AE through Week 96, Percentage of participants discontinuing from study treatment due to an AE through Week 48 | — |
Countries
France, Germany, Italy, Netherlands, Poland, Spain
Outcome results
None listed