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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01489046
First received: December 7, 2011
Last updated: March 28, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention Phase
HIV-1 Infection
 Drug: BMS-986001
Drug: Placebo matching with BMS-986001
Drug: Efavirenz
Drug: Lamivudine
Drug: Tenofovir
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by polymerase chain reaction (PCR) analyses [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by PCR analyses [ Time Frame: Weeks 48 and 96 ] [ Designated as safety issue: No ]
  • Safety as measured by numbers of subjects with SAEs and numbers of subjects with AEs leading to discontinuation [ Time Frame: Weeks 48 and 96 ] [ Designated as safety issue: Yes ]
  • Changes from baseline in CD4+ T-cell counts [ Time Frame: Weeks 24, 48, and 96 ] [ Designated as safety issue: No ]
  • Numbers of subjects with virologic failure who exhibit genotypic substitutions in viral Ribonucleic acid (RNA) [ Time Frame: Weeks 24, 48, and 96 ] [ Designated as safety issue: No ]
  • Maximum observed concentration (Cmax) of BMS-986001 when co-administered with EFV and 3TC [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Time of maximum observed concentration (Tmax) of BMS-986001 when co-administered with EFV and 3TC [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Trough plasma concentration at 24 h post observed dose (Cmin) of BMS-986001 when co-administered with EFV and 3TC [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Trough plasma concentration pre-dose (C0) of BMS-986001 when co-administered with EFV and 3TC [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve in one dosing interval [AUC(0-24)] of BMS-986001 when co-administered with EFV and 3TC [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Average steady-state plasma concentration (Css,avg) of BMS-986001 when co-administered with EFV and 3TC [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: January 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: BMS-986001 (100 mg) + Placebo + Efavirenz + Lamivudine Drug: BMS-986001
Capsules, Oral, 100 mg, Once daily, At least 48 weeks
Drug: Placebo matching with BMS-986001
Capsules, Oral, 0 mg, Once daily, At least 48 weeks
Drug: Efavirenz
Tablets, Oral, 600 mg, Once daily, Entire Treatment Phase
Other Name: Sustiva®
Drug: Lamivudine
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Other Name: Epivir®
Experimental: Arm 2: BMS-986001 (200 mg) + Placebo + Efavirenz + Lamivudine Drug: BMS-986001
Capsules, Oral, 200 mg, Once daily, At least 48 weeks
Drug: Placebo matching with BMS-986001
Capsules, Oral, 0 mg, Once daily, At least 48 weeks
Drug: Efavirenz
Tablets, Oral, 600 mg, Once daily, Entire Treatment Phase
Other Name: Sustiva®
Drug: Lamivudine
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Other Name: Epivir®
Experimental: Arm 3: BMS-986001 (400 mg) + Efavirenz + Lamivudine Drug: BMS-986001
Capsules, Oral, 400 mg, Once daily, At least 48 weeks
Drug: Efavirenz
Tablets, Oral, 600 mg, Once daily, Entire Treatment Phase
Other Name: Sustiva®
Drug: Lamivudine
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Other Name: Epivir®
Experimental: Arm 4: Tenofovir (300 mg) + Efavirenz + Lamivudine Drug: Efavirenz
Tablets, Oral, 600 mg, Once daily, Entire Treatment Phase
Other Name: Sustiva®
Drug: Lamivudine
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Other Name: Epivir®
Drug: Tenofovir
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Other Name: Viread®

Detailed Description:

Double Blind through Week 24. Partially Blind (to subjects, caregivers, Investigators) through Week 48.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489046

  Show 53 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01489046     History of Changes
Other Study ID Numbers: AI467-003, 2011-003329-89
Study First Received: December 7, 2011
Last Updated: March 28, 2013
Health Authority: United States: Food and Drug Administration
South Africa: Medicines Control Council
Australia: Department of Health and Ageing Therapeutic Goods Administration
Thailand: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hungary: National Institute of Pharmacy
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Chile: Instituto de Salud Publica de Chile
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Mexico: Federal Commission for Sanitary Risks Protection
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Canada: Health Canada

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lamivudine
Tenofovir
Tenofovir disoproxil
 Efavirenz
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 21, 2013