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Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01106586
First received: April 14, 2010
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
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: ATV/r + Truvada

  Participant Flow
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  Baseline Characteristics
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Reporting Groups
  Description
Stribild Double-blind Stribild + placebos to match ATV/r + Truvada QD
ATV/r + Truvada Double-blind ATV/r + Truvada + placebo to match Stribild QD
Total Total of all reporting groups

Baseline Measures
    Stribild     ATV/r + Truvada     Total  
Number of Participants  
[units: participants]
 		  353     355     708  
Age  
[units: years]
Mean ± Standard Deviation 		  38  ± 10.5     39  ± 9.8     38  ± 10.2  
Gender  
[units: participants]
 		     
Female     29     39     68  
Male     324     316     640  
Race/Ethnicity, Customized  
[units: participants]
 		     
American Indian or Alaska Native     2     3     5  
Asian     17     17     34  
Black or African Heritage     72     47     119  
Native Hawaiian or Pacific Islander     1     2     3  
White     250     277     527  
Other     11     9     20  
Region of Enrollment  
[units: participants]
 		     
Portugal     1     2     3  
United States     197     185     382  
Thailand     7     4     11  
Austria     12     8     20  
United Kingdom     11     15     26  
Switzerland     0     2     2  
Italy     9     5     14  
France     23     23     46  
Mexico     3     2     5  
Canada     19     22     41  
Belgium     9     12     21  
Australia     30     32     62  
Denmark     1     2     3  
Netherlands     2     4     6  
Germany     29     36     65  
Sweden     0     1     1  
HIV Disease Status  
[units: participants]
 		     
Asymptomatic     285     293     578  
Symptomatic HIV Infections     36     38     74  
AIDS     32     24     56  
Hepatitis B Virus (HBV) Infection Status  
[units: participants]
 		     
Negative     347     346     693  
Positive     5     7     12  
Indeterminate     0     1     1  
Not done     1     1     2  
Hepatitis C Virus (HCV) Infection Status  
[units: participants]
 		     
Negative     335     344     679  
Positive     18     10     28  
Indeterminate     0     0     0  
Not done     0     1     1  
HIV-1 RNA Category (copies/mL)  
[units: participants]
 		     
≤ 100,000     203     214     417  
> 100,000     150     141     291  
CD4 Cell Count (/µL)  
[units: participants]
 		     
≤ 50     12     5     17  
51 to ≤ 200     42     34     76  
201 to ≤ 350     122     124     246  
351 to ≤ 500     122     122     244  
> 500     55     70     125  



  Outcome Measures
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1.  Primary:   The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL   [ Time Frame: Week 48 ]
  Show Outcome Measure 1

2.  Secondary:   The Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL Using the FDA-defined Time to Loss of Virologic Response (TLOVR) Algorithm   [ Time Frame: Week 48 ]
  Show Outcome Measure 2

3.  Secondary:   The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48   [ Time Frame: Baseline to Week 48 ]
  Show Outcome Measure 3

4.  Secondary:   The Percentage of Participants With HIV-1 RNA < 50 Copies/mL   [ Time Frame: Week 48 ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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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.


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.  


Results Point of Contact:  
Name/Title: Christophe Beraud, Director, Regulatory Affairs
Organization: Gilead Sciences, Inc
phone: (650) 522-5093
e-mail: christophe.beraud@gilead.com


Publications of Results:


Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01106586     History of Changes
Other Study ID Numbers: GS-US-236-0103
Study First Received: April 14, 2010
Results First Received: September 20, 2012
Last Updated: December 10, 2012
Health Authority: United States: Food and Drug Administration