Study of the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00869557
First received: March 24, 2009
Last updated: May 22, 2014
Last verified: May 2014
Results First Received: September 20, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV
HIV Infections
Interventions: Drug: Stribild
Drug: Atripla

  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

Participants were enrolled in a total of 30 sites in the United States. The first participant was screened on 30 March 2009.

Last participant visit:

  • Primary endpoint analysis (Week 24): November 2009
  • Week 48 analysis: April 2010
  • Week 96 analysis: March 2011
  • End of study: September 2013

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
126 participants were screened; 71 were randomized (48 to the Stribild group and 23 to the Atripla group). All randomized participants received at least 1 dose of study medication and comprised the safety and intent-to-treat (ITT) analysis sets. No site enrolled more than 7% of participants.

Reporting Groups
  Description
Stribild Stribild (elvitegravir [EVG] 150 mg/GS-9350 [cobicistat; COBI] 150 mg/emtricitabine [FTC] 200 mg/tenofovir disoproxil fumarate [TDF] 300 mg) once daily (QD) and placebo to match Atripla once daily prior to bedtime (QHS) were administered during the double-blind phase. Stribild QD was administered during the extension phase.
Atripla Atripla (efavirenz [EFV] 150 mg/FTC 200 mg/TDF 300 mg) QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.

Participant Flow for 2 periods

Period 1:   Randomized Phase
    Stribild     Atripla  
STARTED     48     23  
COMPLETED     45     21  
NOT COMPLETED     3     2  
Lost to Follow-up                 2                 1  
Investigator's Discretion                 1                 0  
Withdrew Consent                 0                 1  

Period 2:   Extension Phase
    Stribild     Atripla  
STARTED     45     14 [1]
COMPLETED     35     11  
NOT COMPLETED     10     3  
Adverse Event                 2                 2  
Lack of Efficacy                 1                 0  
Lost to Follow-up                 3                 1  
Investigator's Discretion                 2                 0  
Withdrew Consent                 2                 0  
[1] Seven participants completing randomized Atripla treatment did not enter open-label extension phase.



  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.
Safety Analysis Set: participants were randomized and received at least 1 dose of study medication.

Reporting Groups
  Description
Stribild Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
Atripla Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
Total Total of all reporting groups

Baseline Measures
    Stribild     Atripla     Total  
Number of Participants  
[units: participants]
  48     23     71  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     48     23     71  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  36  ± 8.9     35  ± 9.6     36  ± 9.1  
Gender  
[units: participants]
     
Female     4     2     6  
Male     44     21     65  
Race/Ethnicity, Customized  
[units: participants]
     
American Indian or Alaska Native     1     0     1  
Asian     1     0     1  
Black     12     5     17  
White     33     18     51  
Other     1     0     1  
Region of Enrollment  
[units: participants]
     
United States     48     23     71  
HIV Disease Status  
[units: participants]
     
Asymptomatic     40     22     62  
Symptomatic HIV Infections     5     0     5  
AIDS     3     1     4  
Hepatitis B Virus (HBV) Infection Status  
[units: participants]
     
Negative     48     23     71  
Positive     0     0     0  
Hepatitis C Virus (HCV) Infection Status  
[units: participants]
     
Negative     48     23     71  
Positive     0     0     0  
HIV-1 RNA Category (copies/mL)  
[units: participants]
     
≤ 100,000     37     18     55  
> 100,000     11     5     16  
Cluster Determinant 4 (CD4) Cell Count (/µL)  
[units: participants]
     
≤ 50     0     0     0  
51 to ≤ 200     7     0     7  
201 to ≤ 350     17     8     25  
351 to ≤ 500     14     5     19  
> 500     10     10     20  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) Less Than 50 Copies/mL at Week 24   [ Time Frame: Week 24 ]

2.  Secondary:   The Percentage of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 48   [ Time Frame: Week 48 ]

3.  Secondary:   Change From Baseline in HIV-1 RNA (log_10 Copies/mL)   [ Time Frame: Baseline to Weeks 24 and 48 ]

4.  Secondary:   Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 24   [ Time Frame: Baseline to Week 24 ]

5.  Secondary:   Change From Baseline in CD4 Cell Count at Week 48   [ Time Frame: Baseline to Week 48 ]

6.  Secondary:   The Percentage of Participants With Virologic Success at Weeks 24 and 48 Using FDA-Defined Snapshot Analysis and HIV-1 RNA Less Than 50 Copies/mL   [ Time Frame: Baseline to Weeks 24 and 48 ]


  Serious Adverse Events
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Time Frame Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.
Additional Description No text entered.

Reporting Groups
  Description
Stribild Stribild and placebo to match Atripla were administered during the double-blind phase.
Atripla Atripla QHS and placebo to match Stribild QD were administered during the double blind phase.
All Stribild The All Stribild safety analysis set included all participants who received at least 1 dose of Stribild in the randomized phase or in the open-label extension phase. Adverse event data presented in this group include the following: Adverse events collected from participants who were initially randomized to the double-blind Stribild group while they received double-blind Stribild during the randomized phase and open-label Stribild during the extension phase; adverse events collected from the open-label Stribild extension phase only from the participants who were initially randomized to the Atripla group during the randomized phase.

Serious Adverse Events
    Stribild     Atripla     All Stribild  
Total, serious adverse events        
# participants affected / at risk     2/48 (4.17%)     1/23 (4.35%)     9/62 (14.52%)  
Blood and lymphatic system disorders        
Febrile neutropenia † 1      
# participants affected / at risk     0/48 (0.00%)     1/23 (4.35%)     0/62 (0.00%)  
General disorders        
Pyrexia † 1      
# participants affected / at risk     0/48 (0.00%)     1/23 (4.35%)     0/62 (0.00%)  
Infections and infestations        
Cellulitis of male external genital organ † 2      
# participants affected / at risk     1/48 (2.08%)     0/23 (0.00%)     1/62 (1.61%)  
Pneumonia † 2      
# participants affected / at risk     1/48 (2.08%)     0/23 (0.00%)     2/62 (3.23%)  
Staphylococcal infection † 2      
# participants affected / at risk     1/48 (2.08%)     0/23 (0.00%)     1/62 (1.61%)  
Vaccination site cellulitis † 1      
# participants affected / at risk     0/48 (0.00%)     1/23 (4.35%)     0/62 (0.00%)  
Appendicitis † 2      
# participants affected / at risk     0/48 (0.00%)     0/23 (0.00%)     3/62 (4.84%)  
Hepatitis C † 2      
# participants affected / at risk     0/48 (0.00%)     0/23 (0.00%)     1/62 (1.61%)  
Acute hepatitis C † 2      
# participants affected / at risk     0/48 (0.00%)     0/23 (0.00%)     1/62 (1.61%)  
Investigations        
Platelet count decreased † 1      
# participants affected / at risk     0/48 (0.00%)     1/23 (4.35%)     0/62 (0.00%)  
White blood cell count decreased † 1      
# participants affected / at risk     0/48 (0.00%)     1/23 (4.35%)     0/62 (0.00%)  
Musculoskeletal and connective tissue disorders        
Osteonecrosis † 2      
# participants affected / at risk     0/48 (0.00%)     0/23 (0.00%)     1/62 (1.61%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)        
B-cell lymphoma † 1      
# participants affected / at risk     0/48 (0.00%)     1/23 (4.35%)     0/62 (0.00%)  
Nervous system disorders        
Peroneal nerve palsy † 2      
# participants affected / at risk     0/48 (0.00%)     0/23 (0.00%)     1/62 (1.61%)  
Psychiatric disorders        
Bipolar I disorder † 2      
# participants affected / at risk     0/48 (0.00%)     0/23 (0.00%)     1/62 (1.61%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 14.0
2 Term from vocabulary, MedDRA 16.0




  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
No text entered.


  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: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc
e-mail: ClinicalTrialDisclosures@gilead.com


Publications of Results:

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00869557     History of Changes
Other Study ID Numbers: GS-US-236-0104
Study First Received: March 24, 2009
Results First Received: September 20, 2012
Last Updated: May 22, 2014
Health Authority: United States: Food and Drug Administration