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This 2 arm study will evaluate the efficacy, safety and tolerability of saquinavir/ritonavir or lopinavir/ritonavir in combination with emtricitabine/tenofovir in patients with human immunodeficiency virus type 1 (HIV-1) infection who have received no prior HIV treatment. Patients will be randomized to receive either saquinavir/ritonavir 1000/100mg oral (po) twice daily (bid) + emtricitabine/tenofovir 200/300mg po once daily (qd), or lopinavir/ritonavir 400/100mg po bid + emtricitabine/tenofovir 200/300mg po qd. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| saquinavir/ritonavir | Experimental | 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 | Active Comparator | lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| saquinavir [Invirase] | Drug | 1000 milligram (mg) Oral (po) twice daily (bid) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL | 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. | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hobson City | Alabama | 36201 | United States | |||
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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 .
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Lopinavir/Ritonavir |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Lopinavir/ritonavir | Drug | Lopinavir/ritonavir 400/100 mg po bid |
|
|
| Emtricitabine/tenofovir disoproxil fumarate | Drug | Emtricitabine/tenofovir disoproxil fumarate 200/300 mg po qd |
|
|
| Ritonavir | Drug | 100 mg po bid |
|
|
| Week 48 |
| Change From Baseline in HIV-1 RNA Viral Load | 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) | Baseline to Week 48 |
| Change From Baseline in Cluster Differentiation Antigen 4 Positive (CD4+) Lymphocyte Count | 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). | Baseline to Week 48 |
| Number of Participants Assessed for Adverse Events (AEs) | Detailed information for Adverse Events and Serious Adverse Events will be represented in the SAE/AE section of PRS. | reported up to 28 days after the last dose of study treatment. (Up to 52 weeks) |
| Number of Patients Who Discontinued Treatment Due to Abnormal Laboratory Parameters | 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. | baseline and all study visits (Up to Week 52) |
| Tucson |
| Arizona |
| 85745 |
| United States |
| Berkeley | California | 94705 | United States |
| Los Angeles | California | 90028 | United States |
| Washington D.C. | District of Columbia | 20009 | United States |
| Jacksonville | Florida | 32204 | United States |
| Miami | Florida | 33136 | United States |
| Orlando | Florida | 32803 | United States |
| Vero Beach | Florida | 32960 | United States |
| Atlanta | Georgia | 30309 | United States |
| Macon | Georgia | 31201 | United States |
| Chicago | Illinois | 60613 | United States |
| Ypsilanti | Michigan | 48197 | United States |
| St Louis | Missouri | 63139 | United States |
| Newark | New Jersey | 07102 | United States |
| New York | New York | 10011 | United States |
| Huntersville | North Carolina | 28078 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Houston | Texas | 77004 | United States |
| Hamilton | Ontario | L8N 3Z5 | Canada |
| Ottawa | Ontario | K1H 8L6 | Canada |
| Toronto | Ontario | M4N 3M5 | Canada |
| Toronto | Ontario | M5B 1L6 | Canada |
| Toronto | Ontario | M5G 2C4 | Canada |
| Montreal | Quebec | H2L 4P9 | Canada |
| Montreal | Quebec | H2L 5B1 | Canada |
| Montreal | Quebec | H2X 2P4 | Canada |
| Avignon | 84902 | France |
| Lyon | 69288 | France |
| Lyon | 69437 | France |
| Marseille | 13009 | France |
| Marseille | 13385 | France |
| Nantes | 44035 | France |
| Nice | 06202 | France |
| Paris | 75010 | France |
| Paris | 75014 | France |
| Paris | 75651 | France |
| Rouen | 73031 | France |
| Strasbourg | 67091 | France |
| Suresnes | 92150 | France |
| Toulouse | 31052 | France |
| Tourcoing | 59208 | France |
| Ponce | 00717-1563 | Puerto Rico |
| Bangkok | 10330 | Thailand |
lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Lopinavir/Ritonavir | lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL | 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. | intent-to-treat (ITT) Population | Posted | Number | participants | Week 48 |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL | 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. | Intent-to-Treat Population | Posted | Number | participants | Week 48 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HIV-1 RNA Viral Load | 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) | 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. | Posted | Mean | 95% Confidence Interval | copies/mL | Baseline to Week 48 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Cluster Differentiation Antigen 4 Positive (CD4+) Lymphocyte Count | 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). | 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. | Posted | Median | 95% Confidence Interval | cells/mm^3 | Baseline to Week 48 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Assessed for Adverse Events (AEs) | Detailed information for Adverse Events and Serious Adverse Events will be represented in the SAE/AE section of PRS. | Safety population included all randomized patients who received at least one dose of study medication | Posted | Number | participants | reported up to 28 days after the last dose of study treatment. (Up to 52 weeks) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Who Discontinued Treatment Due to Abnormal Laboratory Parameters | 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. | Safety population included all randomized patients who received at least one dose of study medication. | Posted | Number | participants | baseline and all study visits (Up to Week 52) |
|
|
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)
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 24 | 163 | 76 | 163 | ||
| EG001 | Lopinavir/Ritonavir | lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks. | 19 | 168 | 92 | 168 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebral toxoplasmosis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Bronchitis viral | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Cytomegalovirus oesophagitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Encephalitis cytomegalovirus | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Meningitis aseptic | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Pneumocystis jiroveci | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Toxoplasmosis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Acute psychosis | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Delusion | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cytolytic hepatitis | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hepatosplenomegaly | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Kaposi's sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Burkitt's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (10.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Drowning | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Victim of crime | Social circumstances | MedDRA (10.0) | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffman-LaRoche | 800-821-8590 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
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| ID | Term |
|---|---|
| D019258 | Saquinavir |
| D061466 | Lopinavir |
| C558899 | lopinavir-ritonavir drug combination |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011804 | Quinolines |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D000225 | Adenine |
| D011687 | Purines |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
Not provided
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| Male |
|
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|
|
|
|