Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults
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ClinicalTrials.gov Identifier: NCT01440569 |
Recruitment Status :
Completed
First Posted : September 26, 2011
Results First Posted : October 28, 2014
Last Update Posted : December 14, 2016
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Sponsor:
Gilead Sciences
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Gilead Sciences
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Acquired Immunodeficiency Syndrome HIV Infections |
Interventions |
Drug: COBI Drug: DRV Drug: NRTIs |
Enrollment | 314 |
Participant Flow
Recruitment Details | Participants were enrolled at a total of 56 study sites in the United States. The first participant was screened on 22 September 2011. The last study visit occurred on 30 October 2015. |
Pre-assignment Details | 397 participants were screened. |
Arm/Group Title | Treatment-Naive | Treatment-Experienced |
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Treatment-naive participants received darunavir (DRV; 800 mg; 2 × 400 mg tablets) + cobicistat (COBI; 1 × 150 mg tablet) once daily + two nucleoside analogue reverse transcriptase inhibitors (NRTIs; per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase. | Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase. |
Period Title: Main Study | ||
Started | 296 | 18 |
Enrolled and Treated | 295 | 18 |
Completed | 260 | 14 |
Not Completed | 36 | 4 |
Reason Not Completed | ||
Enrolled but not treated | 1 | 0 |
Adverse Event | 9 | 0 |
Pregnancy | 1 | 0 |
Investigator's Discretion | 1 | 1 |
Withdrew Consent | 7 | 1 |
Lost to Follow-up | 13 | 2 |
Subject Non-Compliance | 3 | 0 |
Protocol Violation | 1 | 0 |
Period Title: Open-Label Rollover Phase | ||
Started | 251 [1] | 13 [2] |
Completed | 204 | 7 |
Not Completed | 47 | 6 |
Reason Not Completed | ||
Adverse Event | 3 | 0 |
Pregnancy | 1 | 0 |
Lack of Efficacy | 2 | 0 |
Investigator's Discretion | 3 | 1 |
Withdrew Consent | 11 | 1 |
Lost to Follow-up | 26 | 3 |
Subject Non-Compliance | 1 | 1 |
[1]
9 participants who completed the Main Study did not enroll into the Rollover Phase.
[2]
1 participant who completed the Main Study did not enroll into the Rollover Phase.
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Baseline Characteristics
Arm/Group Title | Treatment-Naive | Treatment-Experienced | Total | |
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Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase. | Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase. | Total of all reporting groups | |
Overall Number of Baseline Participants | 295 | 18 | 313 | |
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Full Analysis Set: participants who were enrolled into the study and received at least one dose of study drug.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 295 participants | 18 participants | 313 participants | |
36 (10.3) | 45 (10.9) | 36 (10.6) | ||
Gender
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 295 participants | 18 participants | 313 participants | |
Female |
29 9.8%
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5 27.8%
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34 10.9%
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Male |
266 90.2%
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13 72.2%
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279 89.1%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 295 participants | 18 participants | 313 participants | |
Hispanic or Latino |
64 21.7%
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4 22.2%
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68 21.7%
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Not Hispanic or Latino |
231 78.3%
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14 77.8%
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245 78.3%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 295 participants | 18 participants | 313 participants |
White | 176 | 11 | 187 | |
Black or African Heritage | 101 | 7 | 108 | |
American Indian or Alaska Native | 4 | 0 | 4 | |
Asian | 4 | 0 | 4 | |
Native Hawaiian or Pacific Islander | 2 | 0 | 2 | |
Other | 8 | 0 | 8 | |
CD4 Count (cells/mm^3)
Mean (Standard Deviation) Unit of measure: Cells/mm^3 |
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Number Analyzed | 295 participants | 18 participants | 313 participants | |
378.2 (199.94) | 197.8 (214.30) | 367.8 (204.79) | ||
HIV-1 RNA (log10 copies/mL)
Mean (Standard Deviation) Unit of measure: Log10 copies/mL |
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Number Analyzed | 295 participants | 18 participants | 313 participants | |
4.8 (0.76) | 4.8 (1.04) | 4.8 (0.78) | ||
Background Antiretroviral Regimen
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 295 participants | 18 participants | 313 participants |
FTC/TDF | 291 | 10 | 301 | |
AZT+FTC/TDF | 0 | 5 | 5 | |
ABC+TDF | 2 | 1 | 3 | |
ABC+FTC/TDF | 1 | 1 | 2 | |
ABC/3TC | 1 | 0 | 1 | |
DDI+FTC | 0 | 1 | 1 | |
[1]
Measure Description: 3TC, lamivudine (Epivir®); ABC, abacavir; ABC/3TC, abacavir/lamivudine coformulation; AZT, azidothymidine or zidovudine; DDI, didanosine; FTC, emtricitabine (Emtriva®); FTC/TDF, emtricitabine/tenofovir disoproxil fumarate coformulation (Truvada®); TDF, tenofovir disoproxil fumarate (Viread®)
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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.
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
- The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
- The study has been completed at all study sites for at least 2 years
Results Point of Contact
Name/Title: | Clinical Trial Disclosures |
Organization: | Gilead Sciences, Inc. |
EMail: | ClinicalTrialDisclosures@gilead.com |
Responsible Party: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT01440569 |
Other Study ID Numbers: |
GS-US-216-0130 2011-003501-22 ( EudraCT Number ) |
First Submitted: | September 22, 2011 |
First Posted: | September 26, 2011 |
Results First Submitted: | October 23, 2014 |
Results First Posted: | October 28, 2014 |
Last Update Posted: | December 14, 2016 |