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

NCT01489046 | Terminated Phase 2 DMC

• 2 other identifiers: AI467-0032011-003329-89
• Study Type: interventional
• Target: 297
• Locations: 13 countries
• Sites: 51

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

Conditions

HIV-1 Infection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• 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

Study Arms (4)

Arm 1: BMS-986001 (100 mg) + Placebo + Efavirenz + Lamivudine

EXPERIMENTAL

Drug: BMS-986001; Drug: Placebo matching with BMS-986001; Drug: Efavirenz; Drug: Lamivudine

Arm 2: BMS-986001 (200 mg) + Placebo + Efavirenz + Lamivudine

EXPERIMENTAL

Drug: BMS-986001; Drug: Placebo matching with BMS-986001; Drug: Efavirenz; Drug: Lamivudine

Arm 3: BMS-986001 (400 mg) + Efavirenz + Lamivudine

EXPERIMENTAL

Drug: BMS-986001; Drug: Efavirenz; Drug: Lamivudine

Arm 4: Tenofovir (300 mg) + Efavirenz + Lamivudine

EXPERIMENTAL

Drug: Efavirenz; Drug: Lamivudine; Drug: Tenofovir

Interventions

BMS-986001 DRUG

Capsules, Oral, 100 mg, Once daily, At least 48 weeks

Arm 1: BMS-986001 (100 mg) + Placebo + Efavirenz + Lamivudine

Placebo matching with BMS-986001 DRUG

Capsules, Oral, 0 mg, Once daily, At least 48 weeks

Arm 1: BMS-986001 (100 mg) + Placebo + Efavirenz + Lamivudine; Arm 2: BMS-986001 (200 mg) + Placebo + Efavirenz + Lamivudine

Efavirenz DRUG

Tablets, Oral, 600 mg, Once daily, Entire Treatment Phase

Also known as: Sustiva®

Arm 1: BMS-986001 (100 mg) + Placebo + Efavirenz + Lamivudine; Arm 2: BMS-986001 (200 mg) + Placebo + Efavirenz + Lamivudine; Arm 3: BMS-986001 (400 mg) + Efavirenz + Lamivudine; Arm 4: Tenofovir (300 mg) + Efavirenz + Lamivudine

Lamivudine DRUG

Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase

Also known as: Epivir®

Arm 1: BMS-986001 (100 mg) + Placebo + Efavirenz + Lamivudine; Arm 2: BMS-986001 (200 mg) + Placebo + Efavirenz + Lamivudine; Arm 3: BMS-986001 (400 mg) + Efavirenz + Lamivudine; Arm 4: Tenofovir (300 mg) + Efavirenz + Lamivudine

Tenofovir DRUG

Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase

Also known as: Viread®

Arm 4: Tenofovir (300 mg) + Efavirenz + Lamivudine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (51)

Uc Davis Medical Center

Sacramento, California, 95817, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

Triple O Medical Services, P.A.

West Palm Beach, Florida, 33401, United States

Location

Aids Research Consortium Of Atlanta

Atlanta, Georgia, 30308, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Local Institution

Washingtondc, Maryland, 20009, United States

Location

Clinic 42 And International Travel Clinic

Minneapolis, Minnesota, 55404, United States

Location

University At Buffalo

Buffalo, New York, 14215, United States

Location

Local Institution

New York, New York, 10011, United States

Location

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

Local Institution

Charlotte, North Carolina, 28209, United States

Location

University Of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Local Institution

Columbia, South Carolina, 29203, United States

Location

Central Texas Clinical Research

Austin, Texas, 78705, United States

Location

St. Hope Foundation

Bellaire, Texas, 77401, United States

Location

North Texas Infectious Disease Consultants

Dallas, Texas, 75246, United States

Location

Tarrant County Infectious Disease Associates

Fort Worth, Texas, 76104, United States

Location

Therapeutic Concepts, P.A.

Houston, Texas, 77004, United States

Location

Local Institution

Ciudad de Buenos Aires, Buenos Aires, C1426EGR, Argentina

Location

Local Institution

Darlinghurst, New South Wales, 2010, Australia

Location

Local Institution

Liverpool, New South Wales, 1871, Australia

Location

Local Institution

Melbourne, Victoria, 3004, Australia

Location

Local Institution

Vancouver, British Columbia, V6Z2C7, Canada

Location

Local Institution

Montreal, Quebec, H2L 4P9, Canada

Location

Local Institution

Montreal, Quebec, H2L 5B1, Canada

Location

Local Institution

Santiago, Santiago Metropolitan, 8207257, Chile

Location

Local Institution

Santiago, Santiago Metropolitan, 8330744, Chile

Location

Local Institution

Bogota, Cundinamarca, Colombia

Location

Local Institution

Lyon, 69004, France

Location

Local Institution

Budapest, 1097, Hungary

Location

Local Institution

Mexico City, Mexico City, 06470, Mexico

Location

Local Institution

Barranco, Lima region, 4, Peru

Location

Local Institution

San Martín de Porres, Lima region, 31, Peru

Location

Local Institution

Cercado, Lima, 1, Peru

Location

Local Institution

Iquitos, Loreto, Peru

Location

Local Institution

Bloemfontein, Free State, 9301, South Africa

Location

Local Institution

Johannesburg, Gauteng, 2198, South Africa

Location

Local Institution

Soweto, Gauteng, 2013, South Africa

Location

Local Institution

Dundee, KwaZulu-Natal, 3000, South Africa

Location

Local Institution

Cape Town, Western Cape, 7925, South Africa

Location

Local Institution

Cape Town, 7530, South Africa

Location

Local Institution

Durban, 4001, South Africa

Location

Local Institution

Durban KZN, 4001, South Africa

Location

Local Institution

Badalona, 08916, Spain

Location

Local Institution

Barcelona, 08036, Spain

Location

Local Institution

Madrid, 28040, Spain

Location

Local Institution

Bangkok, 10330, Thailand

Location

Local Institution

Bangkok, 10400, Thailand

Location

Local Institution

Bangkok, 10700, Thailand

Location

Local Institution

Khon Kaen, 40002, Thailand

Location

Local Institution

Nontaburi, 11000, Thailand

Location

Related Publications (1)

• Gupta SK, McComsey GA, Lombaard J, Echevarria J, Orrell C, Avihingsanon A, Osiyemi O, Santoscoy M, Ray N, Stock DA, Joshi SR, Hanna GJ, Lataillade M. Efficacy, safety, bone and metabolic effects of HIV nucleoside reverse transcriptase inhibitor BMS-986001 (AI467003): a phase 2b randomised, controlled, partly blinded trial. Lancet HIV. 2016 Jan;3(1):e13-22. doi: 10.1016/S2352-3018(15)00231-3. Epub 2015 Dec 12.

  PMID: 26762988 DERIVED

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Interventions

BMS-986001; efavirenz; Lamivudine; Tenofovir

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2011
• First Posted: December 9, 2011
• Study Start: February 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: July 1, 2014
• Last Updated: April 15, 2016

Record last verified: 2016-03

Locations

US (18); AU (3); CL (2); HU (1); PE (4); ES (3); CO (1); FR (1); ZA (8); AR (1); TH (5); CA (3); ME (1)