HIV-1 Infection
Conditions
Brief summary
The purpose of this study is to identify at least one dose of BMS-986001 which is safe, well tolerated, and efficacious when combined with Efavirenz (EFV) + Lamivudine (3TC) for treatment-naive Human Immunodeficiency Virus 1 (HIV-1) infected subjects
Detailed description
Double Blind through Week 24. Partially Blind (to subjects, caregivers, Investigators) through Week 48.
Interventions
DRUGBMS-986001
Capsules, Oral, 100 mg, Once daily, At least 48 weeks
DRUGPlacebo matching with BMS-986001
Capsules, Oral, 0 mg, Once daily, At least 48 weeks
DRUGEfavirenz
Tablets, Oral, 600 mg, Once daily, Entire Treatment Phase
DRUGLamivudine
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
DRUGTenofovir
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age, (or minimum age as determined by local regulatory or as legal requirements dictate, whichever is higher) * Plasma HIV-1 RNA \> 5000 copies/mL * Antiretroviral treatment-naive; defined as no current or previous exposure to \> 1 week of an antiretroviral drug * CD4+ T-cell count \> 200 cells/mm3
Exclusion criteria
* Resistance to any of the study medications \[Tenofovir Disoproxil Fumarate(TDF), Efavirenz (EFV), Lamivudine (3TC)\] or to HIV Protease Inhibitors (PIs) * Contraindications to any of the study drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by polymerase chain reaction (PCR) analyses | Week 24 |
| Safety as measured by numbers of subjects with Serious Adverse Events (SAEs) and numbers of subjects with Adverse Events (AEs) leading to discontinuations | Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in CD4+ T-cell counts | Weeks 24, 48, and 96 |
| Numbers of subjects with virologic failure who exhibit genotypic substitutions in viral Ribonucleic acid (RNA) | Weeks 24, 48, and 96 |
| Maximum observed concentration (Cmax) of BMS-986001 when co-administered with EFV and 3TC | Week 24 |
| Time of maximum observed concentration (Tmax) of BMS-986001 when co-administered with EFV and 3TC | Week 24 |
| Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by PCR analyses | Weeks 48 and 96 |
| Trough plasma concentration pre-dose (C0) of BMS-986001 when co-administered with EFV and 3TC | Week 24 |
| Area under the concentration-time curve in one dosing interval [AUC(0-24)] of BMS-986001 when co-administered with EFV and 3TC | Week 24 |
| Average steady-state plasma concentration (Css,avg) of BMS-986001 when co-administered with EFV and 3TC | Week 24 |
| Trough plasma concentration at 24 h post observed dose (Cmin) of BMS-986001 when co-administered with EFV and 3TC | Week 24 |
| Safety as measured by numbers of subjects with SAEs and numbers of subjects with AEs leading to discontinuation | Weeks 48 and 96 |
Countries
Argentina, Australia, Canada, Chile, Colombia, France, Hungary, Mexico, Peru, South Africa, Spain, Thailand, United States
Outcome results
None listed