HIV-1 InfectionPhase 2NCT01489046
Safety, Efficacy and Dose-response Study of BMS-986001 in Subjects With HIV-1 Infection Who Are Treatment-naive
A Phase 2 study testing BMS-986001, Efavirenz and Lamivudine in people with HIV-1 Infection, run by Bristol-Myers Squibb at 51 sites in 13 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- BMS-986001, Efavirenz and Lamivudine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 297 participants
- Where
- 51 sitesin 13 countries
- Study dates
- Feb 2011to Jul 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
51 sites in 13 countries.
51 sites in 13 countries
United States18 sites
Aids Research Consortium Of Atlanta
Atlanta, Georgia, 30308
Central Texas Clinical Research
Austin, Texas, 78705
St. Hope Foundation
Bellaire, Texas, 77401
University At Buffalo
Buffalo, New York, 14215
Local Institution
Charlotte, North Carolina, 28209
Local Institution
Columbia, South Carolina, 29203
North Texas Infectious Disease Consultants
Dallas, Texas, 75246
Tarrant County Infectious Disease Associates
Fort Worth, Texas, 76104
Therapeutic Concepts, P.A.
Houston, Texas, 77004
Indiana University
Indianapolis, Indiana, 46202
Clinic 42 And International Travel Clinic
Minneapolis, Minnesota, 55404
Local Institution
New York, New York, 10011
Orlando Immunology Center
Orlando, Florida, 32803
University Of Pennsylvania
Philadelphia, Pennsylvania, 19104
Uc Davis Medical Center
Sacramento, California, 95817
Jacobi Medical Center
The Bronx, New York, 10461
Local Institution
Washingtondc, Maryland, 20009
Triple O Medical Services, P.A.
West Palm Beach, Florida, 33401
South Africa8 sites
Local Institution
Bloemfontein, Free State, 9301
Local Institution
Cape Town, Western Cape, 7925
Local Institution
Cape Town, 7530
Local Institution
Dundee, KwaZulu-Natal, 3000
Local Institution
Durban, 4001
Local Institution
Durban KZN, 4001
Local Institution
Johannesburg, Gauteng, 2198
Local Institution
Soweto, Gauteng, 2013
Thailand5 sites
Local Institution
Bangkok, 10330
Local Institution
Bangkok, 10400
Local Institution
Bangkok, 10700
Local Institution
Khon Kaen, 40002
Local Institution
Nontaburi, 11000
Peru4 sites
Local Institution
Barranco, Lima region, 4
Local Institution
Cercado, Lima, 1
Local Institution
Iquitos, Loreto
Local Institution
San Martín de Porres, Lima region, 31
Australia3 sites
Local Institution
Darlinghurst, New South Wales, 2010
Local Institution
Liverpool, New South Wales, 1871
Local Institution
Melbourne, Victoria, 3004
Canada3 sites
Local Institution
Montreal, Quebec, H2L 4P9
Local Institution
Montreal, Quebec, H2L 5B1
Local Institution
Vancouver, British Columbia, V6Z2C7
Spain3 sites
Local Institution
Badalona, 08916
Local Institution
Barcelona, 08036
Local Institution
Madrid, 28040
Chile2 sites
Local Institution
Santiago, Santiago Metropolitan, 8207257
Local Institution
Santiago, Santiago Metropolitan, 8330744
Argentina1 site
Local Institution
Ciudad de Buenos Aires, Buenos Aires, C1426EGR
About this study
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
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
Read the detailed description
Double Blind through Week 24. Partially Blind (to subjects, caregivers, Investigators) through Week 48.
- Conditions
- HIV-1 Infection
- Being tested
- BMS-986001, Placebo matching with BMS-986001, Efavirenz, Lamivudine, Tenofovir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986001Drug
Capsules, Oral, 100 mg, Once daily, At least 48 weeks
BMS-986001Drug
Capsules, Oral, 200 mg, Once daily, At least 48 weeks
BMS-986001Drug
Capsules, Oral, 400 mg, Once daily, At least 48 weeks
Placebo matching with BMS-986001Drug
Capsules, Oral, 0 mg, Once daily, At least 48 weeks
EfavirenzDrug
Also called Sustiva®
Tablets, Oral, 600 mg, Once daily, Entire Treatment Phase
LamivudineDrug
Also called Epivir®
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
TenofovirDrug
Also called Viread®
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: BMS-986001 (100 mg) + Placebo + Efavirenz + Lamivudine | Experimental | Not described Receives: Drug: BMS-986001; Drug: Placebo matching with BMS-986001; Drug: Efavirenz; Drug: Lamivudine |
| Arm 2: BMS-986001 (200 mg) + Placebo + Efavirenz + Lamivudine | Experimental | Not described Receives: Drug: BMS-986001; Drug: Placebo matching with BMS-986001; Drug: Efavirenz; Drug: Lamivudine |
| Arm 3: BMS-986001 (400 mg) + Efavirenz + Lamivudine | Experimental | Not described Receives: Drug: BMS-986001; Drug: Efavirenz; Drug: Lamivudine |
| Arm 4: Tenofovir (300 mg) + Efavirenz + Lamivudine | Experimental | Not described Receives: Drug: Efavirenz; Drug: Lamivudine; Drug: Tenofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by polymerase chain reaction (PCR) analyses
Measured: 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
Measured: Week 24
Secondary outcomes (10)
Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by PCR analyses
Measured: Weeks 48 and 96
Safety as measured by numbers of subjects with SAEs and numbers of subjects with AEs leading to discontinuation
Measured: Weeks 48 and 96
Changes from baseline in CD4+ T-cell counts
Measured: Weeks 24, 48, and 96
Numbers of subjects with virologic failure who exhibit genotypic substitutions in viral Ribonucleic acid (RNA)
Measured: Weeks 24, 48, and 96
Maximum observed concentration (Cmax) of BMS-986001 when co-administered with EFV and 3TC
Measured: Week 24
Time of maximum observed concentration (Tmax) of BMS-986001 when co-administered with EFV and 3TC
Measured: Week 24
Trough plasma concentration at 24 h post observed dose (Cmin) of BMS-986001 when co-administered with EFV and 3TC
Measured: Week 24
Trough plasma concentration pre-dose (C0) of BMS-986001 when co-administered with EFV and 3TC
Measured: 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
Measured: Week 24
Average steady-state plasma concentration (Css,avg) of BMS-986001 when co-administered with EFV and 3TC
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2011 (estimated)
- Study startFeb 2011
- Primary completionMar 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489046
- Sponsor's protocol ID
- AI467-003
- Other IDs
- 2011-003329-89
- Status last verified
- Mar 2016
- First submitted
- 7 Dec 2011
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26762988
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01489046
- Acronym / sponsor ID
- AI467-003
- Conditions
- HIV-1 Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 297 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 9 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986001Capsules, Oral, 100 mg, Once daily, At least 48 weeks | Drug | Arm 1: BMS-986001 (100 mg) + Placebo + Efavirenz + Lamivudine |
| BMS-986001Capsules, Oral, 200 mg, Once daily, At least 48 weeks | Drug | Arm 2: BMS-986001 (200 mg) + Placebo + Efavirenz + Lamivudine |
| BMS-986001Capsules, Oral, 400 mg, Once daily, At least 48 weeks | Drug | Arm 3: BMS-986001 (400 mg) + Efavirenz + Lamivudine |
| Placebo matching with BMS-986001Capsules, Oral, 0 mg, Once daily, At least 48 weeks | Drug | Arm 1: BMS-986001 (100 mg) + Placebo + Efavirenz + Lamivudine, Arm 2: BMS-986001 (200 mg) + Placebo + Efavirenz + Lamivudine |
| EfavirenzAlso: Sustiva®Tablets, Oral, 600 mg, Once daily, Entire Treatment Phase | Drug | 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 |
| LamivudineAlso: Epivir®Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase | Drug | 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 |
| TenofovirAlso: Viread®Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase | Drug | Arm 4: Tenofovir (300 mg) + Efavirenz + Lamivudine |
Primary outcome
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
10 secondary outcomes
Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by PCR analyses
Time frame: Weeks 48 and 96
Safety as measured by numbers of subjects with SAEs and numbers of subjects with AEs leading to discontinuation
Time frame: Weeks 48 and 96
Changes from baseline in CD4+ T-cell counts
Time frame: Weeks 24, 48, and 96
Numbers of subjects with virologic failure who exhibit genotypic substitutions in viral Ribonucleic acid (RNA)
Time frame: Weeks 24, 48, and 96
Maximum observed concentration (Cmax) of BMS-986001 when co-administered with EFV and 3TC
Time frame: Week 24
Time of maximum observed concentration (Tmax) of BMS-986001 when co-administered with EFV and 3TC
Time frame: Week 24
Trough plasma concentration at 24 h post observed dose (Cmin) of BMS-986001 when co-administered with EFV and 3TC
Time frame: Week 24
Trough plasma concentration pre-dose (C0) of BMS-986001 when co-administered with EFV and 3TC
Time frame: 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
Time frame: Week 24
Average steady-state plasma concentration (Css,avg) of BMS-986001 when co-administered with EFV and 3TC
Time frame: Week 24
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Derived from this study: PubMed 26762988Gupta 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
51 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-986001, Efavirenz and Lamivudine in people with HIV-1 Infection, run by Bristol-Myers Squibb at 51 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, South Africa, Thailand, Peru, Australia and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by polymerase chain reaction (PCR) analyses (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01489046, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2016.