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Dolutegravir Compared to Darunavir/Ritonavir , Each in Combination With Dual Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in ART-naive Subjects (FLAMINGO)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01449929
First received: October 6, 2011
Last updated: March 27, 2014
Last verified: March 2014
Results First Received: December 12, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Infection, Human Immunodeficiency Virus
Interventions: Drug: dolutegravir 50 mg OAD
Drug: darunavir 800mg OAD
Drug: ritonavir 100mg OAD

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Total 595 participants were screened; 488 were randomized. A total of 485 participants received at least 1 dose of study medication and comprised the Intent-To-Treat exposed (ITT-E) population. One participant from one closed site was removed from the ITT-E population creating the modified ITT-E population with 484 participants.

Reporting Groups
  Description
DTG 50 mg OD Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) administered in combination with fixed-dose combination (FDC) dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine [ABC/3TC] or tenofovir/emtricitabine [TDF/FTC]) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg OD during an Extension Phase of the study.
DRV 800 mg + RTV 100 mg OD Participants received darunavir (DRV) 800 mg + ritonavir (RTV) 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.

Participant Flow:   Overall Study
    DTG 50 mg OD     DRV 800 mg + RTV 100 mg OD  
STARTED     242     242  
Ongoing     224     213  
COMPLETED     0     0  
NOT COMPLETED     242     242  
Adverse Event                 3                 9  
Lack of Efficacy                 2                 2  
Protocol Violation                 3                 3  
Protocol-defined Stopping Criteria                 1                 1  
Lost to Follow-up                 6                 10  
Withdrawal by Subject                 1                 1  
Physician Decision                 2                 3  
Ongoing                 224                 213  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
DTG 50 mg OD Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
DRV 800 mg + RTV 100 mg OD Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
Total Total of all reporting groups

Baseline Measures
    DTG 50 mg OD     DRV 800 mg + RTV 100 mg OD     Total  
Number of Participants  
[units: participants]
  242     242     484  
Age [1]
[units: Years]
Mean ± Standard Deviation
  35.7  ± 10.66     36.2  ± 10.64     35.9  ± 10.64  
Gender [1]
[units: Participants]
     
Female     31     41     72  
Male     211     201     412  
Race/Ethnicity, Customized [1]
[units: Participants]
     
African American/African Heritage     60     53     113  
American Indian or Alaska Native     3     9     12  
Asian - Central/South Asian Heritage     0     1     1  
Asian - Japanese Heritage     1     0     1  
Asian - South East Asian Heritage     1     0     1  
Native Hawaiian or other Pacific Islander     2     0     2  
White - Arabic/North African Heritage     4     3     7  
White - White/Caucasian/European Heritage     169     173     342  
Mixed Race     1     3     4  
Missing     1     0     1  
[1] Results from the mITT-E are presented in this report.



  Outcome Measures
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1.  Primary:   Percentage of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) at Week 48   [ Time Frame: Week 48 ]

2.  Secondary:   Time to Virologic Suppression (<50 Copies/mL) Through Week 48   [ Time Frame: From Baseline through Week 48 ]

3.  Secondary:   Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <400 c/mL at Week 48   [ Time Frame: Week 48 ]

4.  Secondary:   Change From Baseline in Plasma HIV-1 RNA (log10 c/mL) at Weeks 4, 8, 12, 16, 24, 36 and 48   [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 24, 36 and 48 ]

5.  Secondary:   Change From Baseline in CD4+ and CD8+ Cell Counts   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 36 and 48 for CD4+ and Baseline and Weeks 4, 12, 24 and 48 for CD8+ ]

6.  Secondary:   Number of Participants With HIV-1 Associated Disease Progression With the Indicated Shift to CDC Class C, or New CDC Class C or Death at Week 48   [ Time Frame: Week 48 ]

7.  Secondary:   Change From Baseline in Fasting Low-density Lipoprotein (LDL) Cholesterol Through Week 48   [ Time Frame: From Baseline through Week 48 ]

8.  Secondary:   Percentage of Participants With Grade 2 or Higher Abnormalities in Fasting LDL Cholesterol Through Week 48   [ Time Frame: From Baseline through Week 48 ]

9.  Secondary:   Number of Participants With the Indicated Grade 3 and Grade 4 Maximum Post-Baseline Chemistry and Hematology Laboratory Toxicities   [ Time Frame: From Baseline through Week 48 ]

10.  Secondary:   Number of Participants (Par.) With Detectable Virus That Has Genotypic or Phenotypic Evidence of Treatment-emergent Resistance to DTG, DRV+RTV and Other On-study ART at Time of Protocol Defined Virology Failure (PDVF)   [ Time Frame: Baseline until PDVF up to Week 48 ]

11.  Secondary:   Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Bother Score at Week 4, Week 24, and Week 48   [ Time Frame: Baseline, Week 4, Week 24, and Week 48 ]

12.  Secondary:   Change From Baseline in EQ-5D Utility Scores at Week 24 and Week 48   [ Time Frame: Baseline, Week 24, and Week 48 ]

13.  Secondary:   Change From Baseline in EQ-5D Thermometer Scores at Week 24 and Week 48   [ Time Frame: Baseline, Week 24, and Week 48 ]

14.  Secondary:   Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Total Score at Week 4, Week 24, and Week 48   [ Time Frame: Week 4, Week 24, and Week 48 ]

15.  Secondary:   Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Lifestyle/Ease Sub Score at Week 4, Week 24, and Week 48   [ Time Frame: Week 4, Week 24, and Week 48 ]

16.  Secondary:   Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Convenience Score at Week 4, Week 24, and Week 48   [ Time Frame: Week 4, Week 24, and Week 48 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided by ViiV Healthcare

Publications automatically indexed to this study:

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01449929     History of Changes
Other Study ID Numbers: 114915
Study First Received: October 6, 2011
Results First Received: December 12, 2013
Last Updated: March 27, 2014
Health Authority: United States: Food and Drug Administration