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


  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


  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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