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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 
Overall Participants Analyzed 
[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
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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.

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.

Serious Adverse Events
    Saquinavir/Ritonavir   Lopinavir/Ritonavir
Total, serious adverse events     
# participants affected / at risk   24/163 (14.72%)   19/168 (11.31%) 
Blood and lymphatic system disorders     
Neutropenia † 1     
# participants affected / at risk   1/163 (0.61%)   0/168 (0.00%) 
Cardiac disorders     
Atrial tachycardia † 1     
# participants affected / at risk   1/163 (0.61%)   0/168 (0.00%) 
Gastrointestinal disorders     
Diarrhoea † 1     
# participants affected / at risk   0/163 (0.00%)   1/168 (0.60%) 
Dysphagia † 1     
# participants affected / at risk   1/163 (0.61%)   0/168 (0.00%) 
Pancreatitis acute † 1     
# participants affected / at risk   0/163 (0.00%)   1/168 (0.60%) 
Vomiting † 1     
# participants affected / at risk   0/163 (0.00%)   1/168 (0.60%) 
General disorders     
Drowning † 1     
# participants affected / at risk   1/163 (0.61%)   0/168 (0.00%) 
Hepatobiliary disorders     
Cholecystitis acute † 1     
# participants affected / at risk   0/163 (0.00%)   1/168 (0.60%) 
Cytolytic hepatitis † 1     
# participants affected / at risk   0/163 (0.00%)   1/168 (0.60%) 
Hepatic failure † 1     
# participants affected / at risk   0/163 (0.00%)   1/168 (0.60%) 
Hepatosplenomegaly † 1     
# participants affected / at risk   1/163 (0.61%)   0/168 (0.00%) 
Infections and infestations     
Cerebral toxoplasmosis † 1     
# participants affected / at risk   0/163 (0.00%)   2/168 (1.19%) 
Bronchitis viral † 1     
# participants affected / at risk   0/163 (0.00%)   1/168 (0.60%) 
Clostridial infection † 1     
# participants affected / at risk   0/163 (0.00%)   1/168 (0.60%) 
Cytomegalovirus oesophagitis † 1     
# participants affected / at risk   1/163 (0.61%)   0/168 (0.00%) 
Encephalitis cytomegalovirus † 1     
# participants affected / at risk   1/163 (0.61%)   0/168 (0.00%) 
Gastroenteritis † 1     
# participants affected / at risk   1/163 (0.61%)   0/168 (0.00%) 
Herpes zoster † 1     
# participants affected / at risk   0/163 (0.00%)   1/168 (0.60%) 
Meningitis † 1     
# participants affected / at risk   0/163 (0.00%)   1/168 (0.60%) 
Meningitis aseptic † 1     
# participants affected / at risk   0/163 (0.00%)   1/168 (0.60%) 
Orchitis † 1     
# participants affected / at risk   1/163 (0.61%)   0/168 (0.00%) 
Pneumocystis jiroveci † 1     
# participants affected / at risk   1/163 (0.61%)   0/168 (0.00%) 
Pneumonia † 1     
# participants affected / at risk   1/163 (0.61%)   0/168 (0.00%) 
Progressive multifocal leukoencephalopathy † 1     
# participants affected / at risk   0/163 (0.00%)   1/168 (0.60%) 
Pyelonephritis † 1     
# participants affected / at risk   1/163 (0.61%)   0/168 (0.00%) 
Sepsis † 1     
# participants affected / at risk   1/163 (0.61%)   0/168 (0.00%) 
Septic shock † 1     
# participants affected / at risk   0/163 (0.00%)   1/168 (0.60%) 
Staphylococcal sepsis † 1     
# participants affected / at risk   1/163 (0.61%)   0/168 (0.00%) 
Streptococcal bacteraemia † 1     
# participants affected / at risk   1/163 (0.61%)   0/168 (0.00%) 
Tonsillitis † 1     
# participants affected / at risk   1/163 (0.61%)   0/168 (0.00%) 
Toxoplasmosis † 1     
# participants affected / at risk   1/163 (0.61%)   0/168 (0.00%) 
Viral infection † 1     
# participants affected / at risk   1/163 (0.61%)   0/168 (0.00%) 
Metabolism and nutrition disorders     
Hypoglycaemia † 1     
# participants affected / at risk   0/163 (0.00%)   1/168 (0.60%) 
Hypokalaemia † 1     
# participants affected / at risk   1/163 (0.61%)   0/168 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Kaposi’s sarcoma † 1     
# participants affected / at risk   1/163 (0.61%)   1/168 (0.60%) 
B-cell lymphoma † 1     
# participants affected / at risk   1/163 (0.61%)   0/168 (0.00%) 
Burkitt’s lymphoma † 1     
# participants affected / at risk   0/163 (0.00%)   1/168 (0.60%) 
Nervous system disorders     
Hemiparesis † 1     
# participants affected / at risk   0/163 (0.00%)   1/168 (0.60%) 
Nervous system disorder † 1     
# participants affected / at risk   1/163 (0.61%)   0/168 (0.00%) 
Syncope † 1     
# participants affected / at risk   1/163 (0.61%)   0/168 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Pregnancy † 1     
# participants affected / at risk   1/163 (0.61%)   2/168 (1.19%) 
Psychiatric disorders     
Acute psychosis † 1     
# participants affected / at risk   1/163 (0.61%)   0/168 (0.00%) 
Anxiety † 1     
# participants affected / at risk   0/163 (0.00%)   1/168 (0.60%) 
Completed suicide † 1     
# participants affected / at risk   0/163 (0.00%)   1/168 (0.60%) 
Delusion † 1     
# participants affected / at risk   0/163 (0.00%)   1/168 (0.60%) 
Depression † 1     
# participants affected / at risk   1/163 (0.61%)   0/168 (0.00%) 
Psychotic disorder † 1     
# participants affected / at risk   1/163 (0.61%)   0/168 (0.00%) 
Suicide attempt † 1     
# participants affected / at risk   1/163 (0.61%)   0/168 (0.00%) 
Renal and urinary disorders     
Nephrolithiasis † 1     
# participants affected / at risk   1/163 (0.61%)   0/168 (0.00%) 
Reproductive system and breast disorders     
Cervical dysplasia † 1     
# participants affected / at risk   1/163 (0.61%)   0/168 (0.00%) 
Social circumstances     
Victim of crime † 1     
# participants affected / at risk   1/163 (0.61%)   0/168 (0.00%) 
Vascular disorders     
Peripheral vascular disorder † 1     
# participants affected / at risk   1/163 (0.61%)   0/168 (0.00%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (10.0)




  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
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