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Trial record 29 of 243 for:    "Viral Infectious Disease" | "Lopinavir"

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

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ClinicalTrials.gov Identifier: NCT00105079
Recruitment Status : Completed
First Posted : March 7, 2005
Results First Posted : November 2, 2011
Last Update Posted : November 2, 2011
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: saquinavir [Invirase]
Drug: Lopinavir/ritonavir
Drug: Emtricitabine/tenofovir disoproxil fumarate
Drug: Ritonavir
Enrollment 337
Recruitment Details 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  
Arm/Group Title Saquinavir/Ritonavir Lopinavir/Ritonavir
Hide Arm/Group Description 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 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
Period Title: Overall Study
Started 167 170
Safety Population 163 168
Completed 128 135
Not Completed 39 35
Reason Not Completed
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
Arm/Group Title Saquinavir/Ritonavir Lopinavir/Ritonavir Total
Hide Arm/Group Description 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 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks. Total of all reporting groups
Overall Number of Baseline Participants 167 170 337
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 167 participants 170 participants 337 participants
38.3  (9.31) 37.9  (9.60) 38.1  (9.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants 170 participants 337 participants
Female
31
  18.6%
39
  22.9%
70
  20.8%
Male
136
  81.4%
131
  77.1%
267
  79.2%
1.Primary Outcome
Title Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL
Hide Description

The primary objective of this study was to evaluate the efficacy of saquinavir/ritonavir BID plus emtricitabine/tenofovir QD versus lopinavir/ritonavir BID plus emtricitabine/tenofovir QD in treatment-naïve HIV-1 infected adults.

Blood samples for HIV-1 RNA viral load measurement were collected at the Week 48 clinic visit. The number of participants with HIV-1 RNA results <50 copies/mL is reported.

Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
intent-to-treat (ITT) Population
Arm/Group Title Saquinavir/Ritonavir Lopinavir/Ritonavir
Hide Arm/Group Description:
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 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
Overall Number of Participants Analyzed 167 170
Measure Type: Number
Unit of Measure: participants
Pts. with HIV-1 RNA Viral Load <50 copies/mL - YES 108 108
Pts. with HIV-1 RNA Viral Load <50 copies/mL - NO 59 62
2.Secondary Outcome
Title Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL
Hide Description

The secondary objectives of the study were to evaluate the safety, adherence, and tolerability of saquinavir/ritonavir BID plus emtricitabine/tenofovir QD versus lopinavir/ritonavir BID plus emtricitabine/tenofovir QD in treatment-naïve HIV-1 infected adults.

Blood samples for HIV-1 RNA viral load measurement were collected at the Week 48 clinic visit. The number of participants with HIV-1 RNA results <50 copies/mL and the number of participants with HIV-1 RNA results <400 copies/mL are reported.

Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title Saquinavir/Ritonavir Lopinavir/Ritonavir
Hide Arm/Group Description:
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 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
Overall Number of Participants Analyzed 167 170
Measure Type: Number
Unit of Measure: participants
Patients with <50 Copies/mL 108 108
Patients with <400 Copies/mL 121 127
3.Secondary Outcome
Title Change From Baseline in HIV-1 RNA Viral Load
Hide Description Descriptive statistics for change from baseline in log10 transformed plasma HIV-1 RNA load (copies/mL) were presented by treatment arm. Logarithmic transformation (base 10) was applied to HIV-1 RNA viral load at baseline and at each study visit. Change from baseline in plasma HIV-1 RNA was derived as follows: Change from baseline = Log10 (HIV-1 RNA at week x) – Log10 (HIV-1 RNA at baseline)
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. (n) in each of the categories is the number of participants from the ITT population who had data available at that time point.
Arm/Group Title Saquinavir/Ritonavir Lopinavir/Ritonavir
Hide Arm/Group Description:
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 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
Overall Number of Participants Analyzed 167 170
Mean (95% Confidence Interval)
Unit of Measure: copies/mL
Baseline
5.20
(5.1 to 5.3)
5.17
(5.1 to 5.3)
Week 48 (n=126,133)
1.80
(1.8 to 1.9)
1.83
(1.8 to 1.9)
Change from Baseline to Week 48 (n=126,133)
-3.39
(-3.5 to -3.3)
-3.36
(-3.5 to -3.2)
4.Secondary Outcome
Title Change From Baseline in Cluster Differentiation Antigen 4 Positive (CD4+) Lymphocyte Count
Hide Description Summary statistics for change from baseline in CD4+ lymphocyte count were presented by treatment arm. Change from baseline in CD4+ lymphocyte count was derived as follows: Change from baseline = (CD4+ count at week x) – (CD4+ count at baseline).
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. (n) in each of the categories is the number of participants from the ITT population who had data available at that time point.
Arm/Group Title Saquinavir/Ritonavir Lopinavir/Ritonavir
Hide Arm/Group Description:
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 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
Overall Number of Participants Analyzed 167 170
Median (95% Confidence Interval)
Unit of Measure: cells/mm^3
Baseline (n=166,169)
141.5
(108.0 to 168.0)
142.0
(116.0 to 187.0)
Week 48 (n=122,131)
319.0
(277.0 to 370.0)
348.0
(317.0 to 401.0)
Change from Baseline to Week 48 (n=121,130)
178.0
(159.0 to 213.0)
204.0
(182.0 to 222.0)
5.Secondary Outcome
Title Number of Participants Assessed for Adverse Events (AEs)
Hide Description Detailed information for Adverse Events and Serious Adverse Events will be represented in the SAE/AE section of PRS.
Time Frame reported up to 28 days after the last dose of study treatment. (Up to 52 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized patients who received at least one dose of study medication
Arm/Group Title Saquinavir/Ritonavir Lopinavir/Ritonavir
Hide Arm/Group Description:
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 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
Overall Number of Participants Analyzed 163 168
Measure Type: Number
Unit of Measure: participants
163 168
6.Secondary Outcome
Title Number of Patients Who Discontinued Treatment Due to Abnormal Laboratory Parameters
Hide Description Routine clinical testing, including hematology and standard chemistry panel was performed at all study visits. Laboratory tests for a fasting lipid profile and fasting insulin determination were obtained at baseline, weeks 24 and 48, and the 4-week follow-up visit. The number of participants who discontinued treatment due to an abnormal laboratory result at any visit is reported.
Time Frame baseline and all study visits (Up to Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized patients who received at least one dose of study medication.
Arm/Group Title Saquinavir/Ritonavir Lopinavir/Ritonavir
Hide Arm/Group Description:
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 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
Overall Number of Participants Analyzed 163 168
Measure Type: Number
Unit of Measure: participants
0 0
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)
Adverse Event Reporting 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.
 
Arm/Group Title Saquinavir/Ritonavir Lopinavir/Ritonavir
Hide Arm/Group Description 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 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
All-Cause Mortality
Saquinavir/Ritonavir Lopinavir/Ritonavir
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Saquinavir/Ritonavir Lopinavir/Ritonavir
Affected / at Risk (%) Affected / at Risk (%)
Total   24/163 (14.72%)   19/168 (11.31%) 
Blood and lymphatic system disorders     
Neutropenia  1  1/163 (0.61%)  0/168 (0.00%) 
Cardiac disorders     
Atrial tachycardia  1  1/163 (0.61%)  0/168 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  1  0/163 (0.00%)  1/168 (0.60%) 
Dysphagia  1  1/163 (0.61%)  0/168 (0.00%) 
Pancreatitis acute  1  0/163 (0.00%)  1/168 (0.60%) 
Vomiting  1  0/163 (0.00%)  1/168 (0.60%) 
General disorders     
Drowning  1  1/163 (0.61%)  0/168 (0.00%) 
Hepatobiliary disorders     
Cholecystitis acute  1  0/163 (0.00%)  1/168 (0.60%) 
Cytolytic hepatitis  1  0/163 (0.00%)  1/168 (0.60%) 
Hepatic failure  1  0/163 (0.00%)  1/168 (0.60%) 
Hepatosplenomegaly  1  1/163 (0.61%)  0/168 (0.00%) 
Infections and infestations     
Cerebral toxoplasmosis  1  0/163 (0.00%)  2/168 (1.19%) 
Bronchitis viral  1  0/163 (0.00%)  1/168 (0.60%) 
Clostridial infection  1  0/163 (0.00%)  1/168 (0.60%) 
Cytomegalovirus oesophagitis  1  1/163 (0.61%)  0/168 (0.00%) 
Encephalitis cytomegalovirus  1  1/163 (0.61%)  0/168 (0.00%) 
Gastroenteritis  1  1/163 (0.61%)  0/168 (0.00%) 
Herpes zoster  1  0/163 (0.00%)  1/168 (0.60%) 
Meningitis  1  0/163 (0.00%)  1/168 (0.60%) 
Meningitis aseptic  1  0/163 (0.00%)  1/168 (0.60%) 
Orchitis  1  1/163 (0.61%)  0/168 (0.00%) 
Pneumocystis jiroveci  1  1/163 (0.61%)  0/168 (0.00%) 
Pneumonia  1  1/163 (0.61%)  0/168 (0.00%) 
Progressive multifocal leukoencephalopathy  1  0/163 (0.00%)  1/168 (0.60%) 
Pyelonephritis  1  1/163 (0.61%)  0/168 (0.00%) 
Sepsis  1  1/163 (0.61%)  0/168 (0.00%) 
Septic shock  1  0/163 (0.00%)  1/168 (0.60%) 
Staphylococcal sepsis  1  1/163 (0.61%)  0/168 (0.00%) 
Streptococcal bacteraemia  1  1/163 (0.61%)  0/168 (0.00%) 
Tonsillitis  1  1/163 (0.61%)  0/168 (0.00%) 
Toxoplasmosis  1  1/163 (0.61%)  0/168 (0.00%) 
Viral infection  1  1/163 (0.61%)  0/168 (0.00%) 
Metabolism and nutrition disorders     
Hypoglycaemia  1  0/163 (0.00%)  1/168 (0.60%) 
Hypokalaemia  1  1/163 (0.61%)  0/168 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Kaposi’s sarcoma  1  1/163 (0.61%)  1/168 (0.60%) 
B-cell lymphoma  1  1/163 (0.61%)  0/168 (0.00%) 
Burkitt’s lymphoma  1  0/163 (0.00%)  1/168 (0.60%) 
Nervous system disorders     
Hemiparesis  1  0/163 (0.00%)  1/168 (0.60%) 
Nervous system disorder  1  1/163 (0.61%)  0/168 (0.00%) 
Syncope  1  1/163 (0.61%)  0/168 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Pregnancy  1  1/163 (0.61%)  2/168 (1.19%) 
Psychiatric disorders     
Acute psychosis  1  1/163 (0.61%)  0/168 (0.00%) 
Anxiety  1  0/163 (0.00%)  1/168 (0.60%) 
Completed suicide  1  0/163 (0.00%)  1/168 (0.60%) 
Delusion  1  0/163 (0.00%)  1/168 (0.60%) 
Depression  1  1/163 (0.61%)  0/168 (0.00%) 
Psychotic disorder  1  1/163 (0.61%)  0/168 (0.00%) 
Suicide attempt  1  1/163 (0.61%)  0/168 (0.00%) 
Renal and urinary disorders     
Nephrolithiasis  1  1/163 (0.61%)  0/168 (0.00%) 
Reproductive system and breast disorders     
Cervical dysplasia  1  1/163 (0.61%)  0/168 (0.00%) 
Social circumstances     
Victim of crime  1  1/163 (0.61%)  0/168 (0.00%) 
Vascular disorders     
Peripheral vascular disorder  1  1/163 (0.61%)  0/168 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Saquinavir/Ritonavir Lopinavir/Ritonavir
Affected / at Risk (%) Affected / at Risk (%)
Total   76/163 (46.63%)   92/168 (54.76%) 
Gastrointestinal disorders     
Diarrhoea  1  46/163 (28.22%)  77/168 (45.83%) 
Nausea  1  40/163 (24.54%)  55/168 (32.74%) 
Vomiting  1  21/163 (12.88%)  28/168 (16.67%) 
General disorders     
Fatigue  1  15/163 (9.20%)  12/168 (7.14%) 
Infections and infestations     
Upper respiratory tract infection  1  11/163 (6.75%)  23/168 (13.69%) 
Bronchitis  1  10/163 (6.13%)  5/168 (2.98%) 
Metabolism and nutrition disorders     
DECREASED APPETITE  1  9/163 (5.52%)  8/168 (4.76%) 
Nervous system disorders     
Headache  1  8/163 (4.91%)  14/168 (8.33%) 
DIZZINESS  1  12/163 (7.36%)  14/168 (8.33%) 
Psychiatric disorders     
INSOMNIA  1  6/163 (3.68%)  10/168 (5.95%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
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 Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
Phone: 800-821-8590
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00105079     History of Changes
Other Study ID Numbers: ML18413
First Submitted: March 4, 2005
First Posted: March 7, 2005
Results First Submitted: March 29, 2011
Results First Posted: November 2, 2011
Last Update Posted: November 2, 2011