NCT01489046
Terminated
Phase 2
A Phase IIb Randomized, Controlled, Partially Blinded Clinical Trial to Investigate Safety, Efficacy and Dose-response of BMS-986001 in Treatment-naive HIV-1-infected Subjects, Followed by an Open-label Period on the Recommended Dose
ConditionsHIV-1 Infection
Overview
- Phase
- Phase 2
- Intervention
- Efavirenz
- Conditions
- HIV-1 Infection
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 297
- Locations
- 15
- Primary Endpoint
- Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by polymerase chain reaction (PCR) analyses
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Arm 1: BMS-986001 (100 mg) + Placebo + Efavirenz + Lamivudine
Intervention: Efavirenz
Arm 1: BMS-986001 (100 mg) + Placebo + Efavirenz + Lamivudine
Intervention: BMS-986001
Arm 1: BMS-986001 (100 mg) + Placebo + Efavirenz + Lamivudine
Intervention: Placebo matching with BMS-986001
Arm 1: BMS-986001 (100 mg) + Placebo + Efavirenz + Lamivudine
Intervention: Lamivudine
Arm 2: BMS-986001 (200 mg) + Placebo + Efavirenz + Lamivudine
Intervention: BMS-986001
Arm 2: BMS-986001 (200 mg) + Placebo + Efavirenz + Lamivudine
Intervention: Placebo matching with BMS-986001
Arm 2: BMS-986001 (200 mg) + Placebo + Efavirenz + Lamivudine
Intervention: Efavirenz
Arm 2: BMS-986001 (200 mg) + Placebo + Efavirenz + Lamivudine
Intervention: Lamivudine
Arm 3: BMS-986001 (400 mg) + Efavirenz + Lamivudine
Intervention: BMS-986001
Arm 3: BMS-986001 (400 mg) + Efavirenz + Lamivudine
Intervention: Efavirenz
Arm 3: BMS-986001 (400 mg) + Efavirenz + Lamivudine
Intervention: Lamivudine
Arm 4: Tenofovir (300 mg) + Efavirenz + Lamivudine
Intervention: Efavirenz
Arm 4: Tenofovir (300 mg) + Efavirenz + Lamivudine
Intervention: Lamivudine
Arm 4: Tenofovir (300 mg) + Efavirenz + Lamivudine
Intervention: Tenofovir
Outcomes
Primary Outcomes
Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by polymerase chain reaction (PCR) analyses
Time Frame: 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
Time Frame: Week 24
Secondary Outcomes
- Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by PCR analyses(Weeks 48 and 96)
- Safety as measured by numbers of subjects with SAEs and numbers of subjects with AEs leading to discontinuation(Weeks 48 and 96)
- 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)
- Trough plasma concentration at 24 h post observed dose (Cmin) of BMS-986001 when co-administered with EFV and 3TC(Week 24)
- 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)
Study Sites (15)
Loading locations...
Similar Trials
Completed
Phase 1
A Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986104 in Healthy Male SubjectsRheumatoid ArthritisNCT02211469Bristol-Myers Squibb41
Terminated
Phase 2
Dose-finding Study of BMS-955176 to Treat HIV-1 Infected Treatment-naive AdultsInfection, Human Immunodeficiency VirusNCT02415595ViiV Healthcare210
Completed
Phase 1
A Study to Assess the Safety, Tolerability and Drug Levels of BMS-986172 in Healthy and Obese Participants, Including an Assessment of the Effects of Food on BMS-986172 AbsorptionHealthy ParticipantsNCT04926051Bristol-Myers Squibb40
Completed
Phase 1
A Randomized, Double Blind Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy SubjectsHealthyNCT02790125Bristol-Myers Squibb66
Completed
Phase 2
A Study to Evaluate BMS-986141 Added on to Aspirin or Ticagrelor or the Combination, on Thrombus Formation in a Thrombosis Chamber Model in Participants With Stable Coronary Artery Disease and Healthy ParticipantsCoronary Artery DiseaseHealthy ParticipantsNCT05093790Bristol-Myers Squibb58