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Trial record 19 of 42 for:    " September 14, 2011":" October 14, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

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ClinicalTrials.gov Identifier: NCT01449929
Recruitment Status : Completed
First Posted : October 10, 2011
Results First Posted : March 27, 2014
Last Update Posted : January 16, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This was a 2 sequential treatment period study. In first period (Randomization phase) participants received either dolutegravir (DTG) 50 milligram (mg) or darunavir (DRV) 800 mg with ritonavir (RTV) 100 mg once daily (QD) for 96 weeks. DTG participants who completed 96 Weeks of DTG then continued to receive DTG 50 mg in Extension phase.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 595 participants were screened; 107 were screen failures; 488 were randomized; 485 received at least 1 dose of study medication and comprised the Intent-To-Treat exposed (ITT-E) population of which 1 participant was removed, creating the modified ITT-E population with 484 participants. 123 participants enrolled in Extension Phase.

Reporting Groups
  Description
DTG 50 mg QD Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
DRV 800 mg + RTV 100 mg QD Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
Extension DTG 50 mg DTG participants who successfully completed 96 Weeks of randomized phase continued to receive DTG 50 mg QD during Extension phase

Participant Flow for 2 periods

Period 1:   Randomization Phase 96 Week
    DTG 50 mg QD   DRV 800 mg + RTV 100 mg QD   Extension DTG 50 mg
STARTED   242   242   0 
COMPLETED   209   189   0 
NOT COMPLETED   33   53   0 
Adverse Event                5                13                0 
Lack of Efficacy                3                4                0 
Protocol Violation                5                6                0 
Protocol-defined Stopping Criteria                1                0                0 
Lost to Follow-up                15                18                0 
Withdrawal by Subject                2                8                0 
Physician Decision                2                3                0 
Other: study closed/terminated                0                1                0 

Period 2:   Extension Phase Approximately 3 Years
    DTG 50 mg QD   DRV 800 mg + RTV 100 mg QD   Extension DTG 50 mg
STARTED   0   0   123 
COMPLETED   0   0   115 
NOT COMPLETED   0   0   8 
Adverse Event                0                0                2 
Lack of Efficacy                0                0                2 
Lost to Follow-up                0                0                4 



  Baseline Characteristics

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 QD Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
DRV 800 mg + RTV 100 mg QD Participants received DRV 800 mg + RTV 100 mg QD 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 QD   DRV 800 mg + RTV 100 mg QD   Total 
Overall Participants Analyzed 
[Units: Participants]
 242   242   484 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 35.7  (10.66)   36.2  (10.64)   35.9  (10.64) 
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
     
Female      31  12.8%      41  16.9%      72  14.9% 
Male      211  87.2%      201  83.1%      412  85.1% 
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

1.  Primary:   Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (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 HIV-1 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 European Quality of Life -5 Dimensions (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

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
No text entered.


  More Information

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01449929     History of Changes
Other Study ID Numbers: 114915
First Submitted: October 6, 2011
First Posted: October 10, 2011
Results First Submitted: December 12, 2013
Results First Posted: March 27, 2014
Last Update Posted: January 16, 2018