HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections
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ClinicalTrials.gov Identifier: NCT01384734 |
Recruitment Status
:
Completed
First Posted
: June 29, 2011
Last Update Posted
: April 6, 2018
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Sponsor:
ViiV Healthcare
Information provided by (Responsible Party):
ViiV Healthcare
Tracking Information | ||||
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First Submitted Date ICMJE | June 23, 2011 | |||
First Posted Date ICMJE | June 29, 2011 | |||
Last Update Posted Date | April 6, 2018 | |||
Actual Study Start Date ICMJE | July 26, 2011 | |||
Actual Primary Completion Date | February 18, 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01384734 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections | |||
Official Title ICMJE | A Phase IIb Randomized, Controlled, Partially-Blinded Trial to Investigate Safety, Efficacy and Dose-Response of BMS-663068 in Treatment-experienced HIV-1 Subjects, Followed by an Open-Label Period on the Recommended Dose | |||
Brief Summary | The purpose of this study is to assess the safety, efficacy, tolerability and pharmacokinetics of four doses of BMS-663068 with Raltegravir (RAL) + Tenofovir Disoproxil Fumarate (TDF). At least 1 dose of BMS-663068 can be identified which is safe, well tolerated, and efficacious when combined with RAL + TDF for treatment-experienced HIV-1 infected subjects. PHENOSENSE® is a registered trademark of Monogram Biosciences. | |||
Detailed Description | Masking: Double-blind for BMS-6630368 treatment groups until the Week 24 Primary Endpoint analysis, then open label. The reference groups is all open-label. Arms: 5 (4 BMS-663068 treatment groups and 1 reference group) Intervention Model: Parallel (with unblinding after the Week 24 primary endpoint analysis) |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Infection, Human Immunodeficiency Virus | |||
Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
254 | |||
Original Estimated Enrollment ICMJE |
250 | |||
Actual Study Completion Date | May 12, 2017 | |||
Actual Primary Completion Date | February 18, 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Colombia, Germany, Mexico, Peru, Romania, Russian Federation, South Africa, Spain, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01384734 | |||
Other Study ID Numbers ICMJE | 205889 AI438-011 ( Other Identifier: Bristol-Myers Squibb ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | ViiV Healthcare | |||
Study Sponsor ICMJE | ViiV Healthcare | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | ViiV Healthcare | |||
Verification Date | April 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |