Strategy-confirming Study of BMS-955176 to Treat HIV-1 Infected Treatment-experienced Adults
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ClinicalTrials.gov Identifier: NCT02386098 |
Recruitment Status :
Terminated
(GI Intolerability)
First Posted : March 11, 2015
Results First Posted : August 20, 2018
Last Update Posted : August 20, 2018
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Sponsor:
ViiV Healthcare
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
HIV Infections |
Interventions |
Drug: BMS-955176 Drug: Atazanavir (ATV) Drug: Ritonavir (RTV) Drug: Dolutegravir (DTG) Drug: Tenofovir (TDF) |
Enrollment | 86 |
Participant Flow
Recruitment Details | This study was planned to be conducted in two Stages (96 weeks each); but was terminated early during Stage 1 due to high rates of gastrointestinal (GI) intolerability and early end of the concurrent, 205891 (NCT02415595) formal dose-finding study. Hence, data was collected only in Stage 1 and no participants were enrolled in Stage 2. |
Pre-assignment Details | A total of 288 participants were screened, of which 86 were randomized in a ratio of 1:1 to one of the two treatment arms in Stage 1. |
Arm/Group Title | Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD | Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD | Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD |
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Participants were administered a once daily (QD) oral dose of 120 milligram (mg) BMS-955176 in combination with atazanavir boosted with ritonavir (ATV/r) 300/100 mg QD and dolutegravir (DTG) 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal. | Participants were administered a QD oral dose of 300 mg tenofovir (TDF) in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal. | Participants were planned to be administered a QD oral dose of 120 mg BMS-955176 in combination with atazanavir without ritonavir (ATV) 400 mg QD and DTG 50 mg QD for a duration of 96 weeks. | Participants were planned to be administered a QD oral dose of 180 mg BMS-955176 in combination with ATV 400 mg QD and DTG 50 mg QD for a duration of 96 weeks. | Participants were planned to be administered a QD oral dose of 300 mg TDF in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks. |
Period Title: Stage 1 (96 Weeks) | |||||
Started | 43 | 43 | 0 | 0 | 0 |
Completed | 0 | 0 | 0 | 0 | 0 |
Not Completed | 43 | 43 | 0 | 0 | 0 |
Reason Not Completed | |||||
Other: Administrative reason by sponsor | 30 | 29 | 0 | 0 | 0 |
Adverse Event | 2 | 1 | 0 | 0 | 0 |
Lost to Follow-up | 2 | 2 | 0 | 0 | 0 |
Other:Protocol defined stopping criteria | 0 | 2 | 0 | 0 | 0 |
Withdrawal by Subject | 3 | 1 | 0 | 0 | 0 |
Other | 1 | 0 | 0 | 0 | 0 |
Other: Breach of good clinical practice | 5 | 8 | 0 | 0 | 0 |
Period Title: Stage 2 (96 Weeks) | |||||
Started | 0 | 0 | 0 | 0 | 0 |
Completed | 0 | 0 | 0 | 0 | 0 |
Not Completed | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD | Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD | Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Total | |
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Participants were administered a once daily (QD) oral dose of 120 milligram (mg) BMS-955176 in combination with atazanavir boosted with ritonavir (ATV/r) 300/100 mg QD and dolutegravir (DTG) 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal. | Participants were administered a QD oral dose of 300 mg tenofovir (TDF) in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal. | Participants were planned to be administered a QD oral dose of 120 mg BMS-955176 in combination with atazanavir without ritonavir (ATV) 400 mg QD and DTG 50 mg QD for a duration of 96 weeks. | Participants were planned to be administered a QD oral dose of 180 mg BMS-955176 in combination with ATV 400 mg QD and DTG 50 mg QD for a duration of 96 weeks. | Participants were planned to be administered a QD oral dose of 300 mg TDF in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks. | Total of all reporting groups | |
Overall Number of Baseline Participants | 38 | 35 | 0 | 0 | 0 | 73 | |
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Modified intent to treat (mITT) Population comprised of randomized participants who received at least one dose of BMS-955176 or TDF. Data from 13 participants randomized at a single site were excluded due to a breach of good clinical practice (GCP) that indicated participants may not have been properly consented to participate in the study.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 38 participants | 35 participants | 0 participants | 0 participants | 0 participants | 73 participants | |
39.8 (11.45) | 41.7 (12.06) | 40.7 (11.70) | |||||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 38 participants | 35 participants | 0 participants | 0 participants | 0 participants | 73 participants | |
Female |
7 18.4%
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8 22.9%
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15 20.5%
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Male |
31 81.6%
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27 77.1%
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58 79.5%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 38 participants | 35 participants | 0 participants | 0 participants | 0 participants | 73 participants | |
White |
14 36.8%
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17 48.6%
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31 42.5%
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Black/African American |
6 15.8%
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2 5.7%
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8 11.0%
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Asian |
4 10.5%
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4 11.4%
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8 11.0%
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Unknown |
14 36.8%
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12 34.3%
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26 35.6%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: | GSK Response Center |
Organization: | GlaxoSmithKline |
Phone: | 866-435-7343 |
EMail: | GSKClinicalSupportHD@gsk.com |
Responsible Party: | ViiV Healthcare |
ClinicalTrials.gov Identifier: | NCT02386098 |
Other Study ID Numbers: |
205892 AI468-048 ( Other Identifier: Bristol-Myers Squibb ) |
First Submitted: | March 6, 2015 |
First Posted: | March 11, 2015 |
Results First Submitted: | June 4, 2018 |
Results First Posted: | August 20, 2018 |
Last Update Posted: | August 20, 2018 |