Safety, Efficacy and Dose-response Study of BMS-986001 in Subjects With HIV-1 Infection Who Are Treatment-naive

Phase 2

Terminated

• Conditions: HIV-1 Infection
• Interventions: Drug: BMS-986001; Drug: Placebo matching with BMS-986001; Drug: Lamivudine; Drug: Tenofovir; Drug: Efavirenz

• Registration Number: NCT01489046
• Lead Sponsor: Bristol-Myers Squibb

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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-12-07
• Study First Submitted QC: 2011-12-08
• Study First Posted: 2011-12-09
• Primary Completion: 2013-03
• Study Completion: 2014-07
• Status Verified: 2016-03
• Disposition First Submitted: 2016-03-17
• Disposition First Submitted QC: 2016-03-17
• Last Update Submitted: 2016-03-17
• Disposition First Posted: 2016-04-15
• Last Update Posted: 2016-04-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 297

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 4: Tenofovir (300 mg) + Efavirenz + Lamivudine	Tenofovir	-
Arm 1: BMS-986001 (100 mg) + Placebo + Efavirenz + Lamivudine	BMS-986001	-
Arm 2: BMS-986001 (200 mg) + Placebo + Efavirenz + Lamivudine	Placebo matching with BMS-986001	-
Arm 1: BMS-986001 (100 mg) + Placebo + Efavirenz + Lamivudine	Placebo matching with BMS-986001	-
Arm 2: BMS-986001 (200 mg) + Placebo + Efavirenz + Lamivudine	BMS-986001	-
Arm 3: BMS-986001 (400 mg) + Efavirenz + Lamivudine	BMS-986001	-
Arm 4: Tenofovir (300 mg) + Efavirenz + Lamivudine	Lamivudine	-
Arm 1: BMS-986001 (100 mg) + Placebo + Efavirenz + Lamivudine	Lamivudine	-
Arm 1: BMS-986001 (100 mg) + Placebo + Efavirenz + Lamivudine	Efavirenz	-
Arm 2: BMS-986001 (200 mg) + Placebo + Efavirenz + Lamivudine	Efavirenz	-
Arm 2: BMS-986001 (200 mg) + Placebo + Efavirenz + Lamivudine	Lamivudine	-
Arm 3: BMS-986001 (400 mg) + Efavirenz + Lamivudine	Efavirenz	-
Arm 3: BMS-986001 (400 mg) + Efavirenz + Lamivudine	Lamivudine	-
Arm 4: Tenofovir (300 mg) + Efavirenz + Lamivudine	Efavirenz	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (15)

Orlando Immunology Center; 🇺🇸 Orlando, Florida, United States

Jacobi Medical Center; 🇺🇸 Bronx, New York, United States

Local Institution; 🇹🇭 Nontaburi, Thailand

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

Therapeutic Concepts, P.A.; 🇺🇸 Houston, Texas, United States

Aids Research Consortium Of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Clinic 42 And International Travel Clinic; 🇺🇸 Minneapolis, Minnesota, United States

North Texas Infectious Disease Consultants; 🇺🇸 Dallas, Texas, United States

Uc Davis Medical Center; 🇺🇸 Sacramento, California, United States

University Of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University At Buffalo; 🇺🇸 Buffalo, New York, United States

St. Hope Foundation; 🇺🇸 Bellaire, Texas, United States

Central Texas Clinical Research; 🇺🇸 Austin, Texas, United States

Tarrant County Infectious Disease Associates; 🇺🇸 Fort Worth, Texas, United States

Triple O Medical Services, P.A.; 🇺🇸 West Palm Beach, Florida, United States