GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00105079
First received: March 4, 2005
Last updated: September 23, 2011
Last verified: September 2011
Results First Received: March 29, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: saquinavir [Invirase]
Drug: Lopinavir/ritonavir
Drug: Emtricitabine/tenofovir disoproxil fumarate
Drug: Ritonavir

  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
This study was conducted between 28 April 2005 and 24 August 2007 at 38 study centers in the United States, Canada, France and Thailand. Patients were randomized to receive saquinavir/ritonavir 1000/100 mg PO BID plus emtricitabine/tenofovir 200/300 mg PO QD or lopinavir/ritonavir 400/100 mg PO BID plus emtricitabine/tenofovir 200/300 mg PO QD .

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Saquinavir/Ritonavir saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
Lopinavir/Ritonavir lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.

Participant Flow:   Overall Study
    Saquinavir/Ritonavir     Lopinavir/Ritonavir  
STARTED     167     170  
Safety Population     163     168  
COMPLETED     128     135  
NOT COMPLETED     39     35  
Adverse Event                 5                 12  
Death                 3                 1  
Lost to Follow-up                 12                 12  
Lack of Efficacy                 9                 3  
Refused treatment                 6                 4  
Violation of selection criteria at entry                 0                 2  
Protocol Violation                 1                 0  
not specified                 3                 1  



  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.
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Reporting Groups
  Description
Saquinavir/Ritonavir saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
Lopinavir/Ritonavir lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
Total Total of all reporting groups

Baseline Measures
    Saquinavir/Ritonavir     Lopinavir/Ritonavir     Total  
Number of Participants  
[units: participants]
  167     170     337  
Age  
[units: years]
Mean ± Standard Deviation
  38.3  ± 9.31     37.9  ± 9.60     38.1  ± 9.45  
Gender  
[units: participants]
     
Female     31     39     70  
Male     136     131     267  



  Outcome Measures
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1.  Primary:   Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL   [ Time Frame: Week 48 ]

2.  Secondary:   Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL   [ Time Frame: Week 48 ]

3.  Secondary:   Change From Baseline in HIV-1 RNA Viral Load   [ Time Frame: Baseline to Week 48 ]

4.  Secondary:   Change From Baseline in Cluster Differentiation Antigen 4 Positive (CD4+) Lymphocyte Count   [ Time Frame: Baseline to Week 48 ]

5.  Secondary:   Number of Participants Assessed for Adverse Events (AEs)   [ Time Frame: reported up to 28 days after the last dose of study treatment. (Up to 52 weeks) ]

6.  Secondary:   Number of Patients Who Discontinued Treatment Due to Abnormal Laboratory Parameters   [ Time Frame: baseline and all study visits (Up to Week 52) ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame All new nonserious AEs and SAEs, irrespective of causal relationship, were reported up to 28 days after the last dose of study treatment. Serious AEs considered related to the test drug were to be reported indefinitely. (Up to 52 weeks)
Additional Description The safety population included all randomized patients who took at least 1 dose of the trial medication and had at least 1 post-baseline safety assessment.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Saquinavir/Ritonavir saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
Lopinavir/Ritonavir lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.

Other Adverse Events
    Saquinavir/Ritonavir     Lopinavir/Ritonavir  
Total, other (not including serious) adverse events      
# participants affected / at risk     76/163     92/168  
Gastrointestinal disorders      
Diarrhoea † 1    
# participants affected / at risk     46/163 (28.22%)     77/168 (45.83%)  
Nausea † 1    
# participants affected / at risk     40/163 (24.54%)     55/168 (32.74%)  
Vomiting † 1    
# participants affected / at risk     21/163 (12.88%)     28/168 (16.67%)  
General disorders      
Fatigue † 1    
# participants affected / at risk     15/163 (9.20%)     12/168 (7.14%)  
Infections and infestations      
Upper respiratory tract infection † 1    
# participants affected / at risk     11/163 (6.75%)     23/168 (13.69%)  
Bronchitis † 1    
# participants affected / at risk     10/163 (6.13%)     5/168 (2.98%)  
Metabolism and nutrition disorders      
DECREASED APPETITE † 1    
# participants affected / at risk     9/163 (5.52%)     8/168 (4.76%)  
Nervous system disorders      
Headache † 1    
# participants affected / at risk     8/163 (4.91%)     14/168 (8.33%)  
DIZZINESS † 1    
# participants affected / at risk     12/163 (7.36%)     14/168 (8.33%)  
Psychiatric disorders      
INSOMNIA † 1    
# participants affected / at risk     6/163 (3.68%)     10/168 (5.95%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (10.0)



  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: Medical Communications
Organization: Hoffman-LaRoche
phone: 800-821-8590


No publications provided


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00105079     History of Changes
Other Study ID Numbers: ML18413
Study First Received: March 4, 2005
Results First Received: March 29, 2011
Last Updated: September 23, 2011
Health Authority: United States: Food and Drug Administration