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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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This is a pilot study to examine if the novel treatment regimen maraviroc plus boosted atazanavir can be expected to be safe and efficacious in treatment naive HIV infected patients. Based on the results from this study, a confirmatory phase 3 study may be conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | maraviroc (Selzentry, Celsentri) 150 mg QD + atazanavir (Reyataz) /ritonavir (Norvir) 300/100mg QD Subjects experiencing unconjugated hyperbilirubinemia attributable to atazanavir (Reyataz) /ritonavir (Norvir) without any other etiology of hyperbilirubinemia, responding to the therapy without virologic failure, but expressing cosmetic concerns because of the jaundice or scleral icterus (associated with bilirubin elevations) and wish to discontinue atazanavir (Reyataz) in spite of reassurances by the investigator, will be permitted on a single occasion only to switch to another protease inhibitor either darunavir (Prezista)/ritonavir (Norvir)((800/100 mg) QD or lopinavir/ritonavir (Kaletra, Aluvia)(400/100mg) BID and remain in the study. If the investigator decides to switch to a protease inhibitor other than darunavir (Prezista)/ritonavir (Norvir) or lopinavir/ritonavir (Kaletra, Aluvia)(, then the subject must be discontinued from the study. |
|
| Arm B | Experimental | emtricitabine/tenofovir (Truvada) 200/300mg QD + atazanavir (Reyataz) /ritonavir (Norvir) 300/100 mg QD Subjects experiencing unconjugated hyperbilirubinemia attributable to atazanavir (Reyataz) /ritonavir (Norvir) without any other etiology of hyperbilirubinemia, responding to the therapy without virologic failure, but expressing cosmetic concerns because of the jaundice or scleral icterus (associated with bilirubin elevations) and wish to discontinue atazanavir in spite of reassurances by the investigator, will be permitted on a single occasion only to switch to another protease inhibitor either darunavir/ritonavir (800/100 mg) QD or lopinavir/ritonavir (400/100mg) BID and remain in the study. If the investigator decides to switch to a protease inhibitor other than darunavir/ritonavir or lopinavir/ritonavir, then the subject must be discontinued from the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| maraviroc | Drug | maraviroc (Selzentry, Celsentri) 150mg QD + atazanavir (Reyataz) /ritonavir (Norvir) (300/100mg) QD OR maraviroc (Selzentry, Celsentri) 150mg QD+ darunavir (Prezista)/ritonavir (Norvir) (800/100 mg) QD (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by darunavir (Prezista)/ritonavir (Norvir)) OR maraviroc (Selzentry, Celsentri) 150mg QD+ lopinavir/ritonavir (Kaletra, Aluvia) (400/100 mg) BID (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by lopinavir/ritonavir (Kaletra, Aluvia)) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than 50 Copies/Milliliter (mL) | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| HIV-1 RNA Levels at Baseline | Baseline | |
| Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14 | Plasma HIV-1 RNA levels were evaluated for first 15 participants enrolled at United States (U.S) sites only. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Los Angeles | California | 90027 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Maraviroc+ Atazanavir / Ritonavir | Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks. |
| FG001 | Atazanavir / Ritonavir + Emtricitabine / Tenofovir |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| maraviroc | Drug | emtricitabine/tenofovir (Truvada) 200/300mg QD + atazanavir (Reyataz) /ritonavir (Norvir) 300/100 mg QD OR emtricitabine/tenofovir (Truvada) 200/300 mg QD + darunavir (Prezista)/ritonavir (Norvir) (800/100 mg) QD (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by darunavir (Prezista)/ritonavir (Norvir)) OR emtricitabine/tenofovir (Truvada) 200/300 mg QD + lopinavir/ritonavir(Kaletra, Aluvia) (400/100 mg) BID (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by lopinavir/ritonavir (Kaletra, Aluvia)) |
|
|
| Baseline , Days 4, 7, 10 and 14 |
| Maximum Observed Plasma Concentration (Cmax) of Maraviroc | Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose) |
| Minimum Observed Plasma Concentration (Cmin) of Maraviroc | Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose) |
| Average Observed Plasma Concentration (Cavg) of Maraviroc | Cavg was described as area under the plasma concentration-time profile from time zero to time 24 hours (AUC24) divided by the dosing interval (AUC24/ 24). | Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose) |
| Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96 | Baseline, Week 16, Week 24, Week 48, Week 96 |
| Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96 |
| Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96 |
| Time to Loss of Virological Response (TLOVR) | TLOVR (virological failure) was defined as the time from first dose of study treatment (Day 1) until the time of virologic failure using the time to loss of virologic response algorithm. | Baseline through Week 96 |
| Time-Averaged Difference (TAD) in log10 Viral Load | TAD was calculated as area under the curve of HIV divided by time period minus baseline HIV where HIV was denoted as HIV-1 RNA (log10 copies/mL). | Week 16, Week 24, Week 48, Week 96 |
| Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96 | Baseline, Week 16, Week 24, Week 48, Week 96 |
| Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96 | Baseline, Week 16, Week 24, Week 48, Week 96 |
| Number of Participants With Genotypic Resistance | Genotypic resistance was assessed for all participants at screening and was evaluated for protease inhibitors (PIs), Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs) using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96. | Week 96 or Time of treatment failure |
| Number of Participants With Phenotypic Resistance | Phenotypic resistance was assessed for all participants at screening and was evaluated for PIs, NRTIs, and NNRTIs using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96. | Week 96 or Time of treatment failure |
| Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay | Viral tropism was determined using the trofile assay with enhanced sensitivity for participants with HIV-1 RNA greater than equal to 1000 copies/mL. The enhanced trofile assay had the sensitivity to detect 100 percent of spiked samples when C-X-C chemokine receptor type 4 {CXCR4} [X4]-using HIV-1 RNA represented 0.3 percent of the total viral population. | Baseline to Week 96 or Time of treatment Failure |
| Los Angeles |
| California |
| 90028 |
| United States |
| Pfizer Investigational Site | Los Angeles | California | 90048 | United States |
| Pfizer Investigational Site | Los Angeles | California | 90069 | United States |
| Pfizer Investigational Site | Norwalk | Connecticut | 06851 | United States |
| Pfizer Investigational Site | Washington D.C. | District of Columbia | 20009 | United States |
| Pfizer Investigational Site | Miami | Florida | 33133 | United States |
| Pfizer Investigational Site | Miami | Florida | 33136 | United States |
| Pfizer Investigational Site | Miami | Florida | 33137 | United States |
| Pfizer Investigational Site | Orlando | Florida | 32803 | United States |
| Pfizer Investigational Site | Pensacola | Florida | 32504 | United States |
| Pfizer Investigational Site | St. Petersburg | Florida | 33713 | United States |
| Pfizer Investigational Site | Tampa | Florida | 33602 | United States |
| Pfizer Investigational Site | Tampa | Florida | 33614 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30312 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60657 | United States |
| Pfizer Investigational Site | Springfield | Massachusetts | 01107 | United States |
| Pfizer Investigational Site | Springfield | Massachusetts | 01199 | United States |
| Pfizer Investigational Site | Ann Arbor | Michigan | 48109 | United States |
| Pfizer Investigational Site | Omaha | Nebraska | 68106 | United States |
| Pfizer Investigational Site | New York | New York | 10003 | United States |
| Pfizer Investigational Site | Huntersville | North Carolina | 28078 | United States |
| Pfizer Investigational Site | Addison | Texas | 75001 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75204 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75390 | United States |
| Pfizer Investigational Site | Houston | Texas | 77098 | United States |
| Pfizer Investigational Site | Spokane | Washington | 99204 | United States |
| Pfizer Investigational Site | Berlin | 10243 | Germany |
| Pfizer Investigational Site | Berlin | 12157 | Germany |
| Pfizer Investigational Site | Cologne | 50937 | Germany |
| Pfizer Investigational Site | Frankfurt am Main | 60590 | Germany |
| Pfizer Investigational Site | Hamburg | 20146 | Germany |
| Pfizer Investigational Site | München | 80335 | Germany |
| Pfizer Investigational Site | Alicante | Alicante | 03010 | Spain |
| Pfizer Investigational Site | Barcelona | Barcelona | 08036 | Spain |
| Pfizer Investigational Site | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Pfizer Investigational Site | Córdoba | Cordoba | 14004 | Spain |
| Pfizer Investigational Site | Madrid | Madrid | 28046 | Spain |
| Pfizer Investigational Site | Seville | Sevilla | 41013 | Spain |
Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Maraviroc+ Atazanavir / Ritonavir | Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks. |
| BG001 | Atazanavir / Ritonavir + Emtricitabine / Tenofovir | Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 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 | Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than 50 Copies/Milliliter (mL) | Full Analysis Set (FAS) population included those participants who had taken at least one dose of the study drug, had baseline and at least one post baseline measurement. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 48 |
|
|
| |||||||||||||||||||||||||||||
| Secondary | HIV-1 RNA Levels at Baseline | FAS population included those participants who had taken at least one dose of the study drug, had baseline and at least one post baseline measurement. | Posted | Mean | Standard Deviation | copies/mL | Baseline |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14 | Plasma HIV-1 RNA levels were evaluated for first 15 participants enrolled at United States (U.S) sites only. | First 15 participants who were enrolled at U.S sites and had taken the study drug . | Posted | Mean | Standard Deviation | copies/mL | Baseline , Days 4, 7, 10 and 14 |
|
| |||||||||||||||||||||||||||||
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Maraviroc | Pharmacokinetic (PK) parameter analysis population included first 15 participants treated with maraviroc. | Posted | Median | Full Range | nanogram (ng)/mL | Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Minimum Observed Plasma Concentration (Cmin) of Maraviroc | PK parameter analysis population included first 15 participants treated with maraviroc. | Posted | Median | Full Range | ng/mL | Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Average Observed Plasma Concentration (Cavg) of Maraviroc | Cavg was described as area under the plasma concentration-time profile from time zero to time 24 hours (AUC24) divided by the dosing interval (AUC24/ 24). | PK parameter analysis population included first 15 participants treated with maraviroc. | Posted | Mean | Standard Deviation | ng/mL | Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose) |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96 | FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here "n" signified participants who received the study drug and evaluated at the time point. | Posted | Mean | Standard Deviation | log10 copies/ml | Baseline, Week 16, Week 24, Week 48, Week 96 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA | FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here "n" signified participants who received the study drug and evaluated at the time point. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA | FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here "n" signified participants who received the study drug and evaluated at the time point. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Time to Loss of Virological Response (TLOVR) | TLOVR (virological failure) was defined as the time from first dose of study treatment (Day 1) until the time of virologic failure using the time to loss of virologic response algorithm. | FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. | Posted | Mean | Standard Error | Days | Baseline through Week 96 |
|
| |||||||||||||||||||||||||||||
| Secondary | Time-Averaged Difference (TAD) in log10 Viral Load | TAD was calculated as area under the curve of HIV divided by time period minus baseline HIV where HIV was denoted as HIV-1 RNA (log10 copies/mL). | FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here N (Number of participants analyzed) signified participants evaluable for the measure. | Posted | Mean | Standard Error | log10 copies/mL | Week 16, Week 24, Week 48, Week 96 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96 | FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here "n" signified participants who received the study drug and evaluated at the time point. | Posted | Mean | Standard Deviation | cells/microliter (cells/mcL) | Baseline, Week 16, Week 24, Week 48, Week 96 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96 | FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here "n" signified participants who received the study drug and evaluated at the time point. | Posted | Mean | Standard Deviation | cells/mcL | Baseline, Week 16, Week 24, Week 48, Week 96 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Genotypic Resistance | Genotypic resistance was assessed for all participants at screening and was evaluated for protease inhibitors (PIs), Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs) using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96. | FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. | Posted | Number | Participants | Week 96 or Time of treatment failure |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Phenotypic Resistance | Phenotypic resistance was assessed for all participants at screening and was evaluated for PIs, NRTIs, and NNRTIs using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96. | FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. | Posted | Number | Participants | Week 96 or Time of treatment failure |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay | Viral tropism was determined using the trofile assay with enhanced sensitivity for participants with HIV-1 RNA greater than equal to 1000 copies/mL. The enhanced trofile assay had the sensitivity to detect 100 percent of spiked samples when C-X-C chemokine receptor type 4 {CXCR4} [X4]-using HIV-1 RNA represented 0.3 percent of the total viral population. | FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. | Posted | Number | Participants | Baseline to Week 96 or Time of treatment Failure |
|
|
Baseline to follow-up period (28 days after the last dose of study)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Maraviroc+ Atazanavir / Ritonavir | Maraviroc 150 milligram (mg) tablets once daily along with atazanavir 300 mg or ritonavir 100 mg tablets once daily were orally administered for 96 weeks. | 13 | 60 | 55 | 60 | ||
| EG001 | Atazanavir / Ritonavir + Emtricitabine/ Tenofovir | Atazanavir/ritonavir 300 mg/100 mg tablets QD along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks. | 11 | 61 | 58 | 61 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchogenic cyst | Congenital, familial and genetic disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Anogenital warts | Infections and infestations | MeDRA v14.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MeDRA v14.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MeDRA v14.0 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MeDRA v14.0 | Non-systematic Assessment |
| |
| Parotitis | Gastrointestinal disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MeDRA v14.0 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MeDRA v14.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MeDRA v14.0 | Non-systematic Assessment |
| |
| Sepsis syndrome | Infections and infestations | MeDRA v14.0 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MeDRA v14.0 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MeDRA v14.0 | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MeDRA v14.0 | Non-systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MeDRA v14.0 | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MeDRA v14.0 | Non-systematic Assessment |
| |
| Reversible ischaemic neurological deficit | Nervous system disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Pulmonary sarcoidosis | Respiratory, thoracic and mediastinal disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Intra-abdominal haemorrhage | Vascular disorders | MeDRA v14.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular icterus | Eye disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Anogenital warts | Infections and infestations | MeDRA v14.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MeDRA v14.0 | Non-systematic Assessment |
| |
| Gonorrhoea | Infections and infestations | MeDRA v14.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MeDRA v14.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MeDRA v14.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MeDRA v14.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MeDRA v14.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MeDRA v14.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MeDRA v14.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MeDRA v14.0 | Non-systematic Assessment |
| |
| Blood amylase increased | Investigations | MeDRA v14.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MeDRA v14.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MeDRA v14.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MeDRA v14.0 | Non-systematic Assessment |
| |
| Blood uric acid increased | Investigations | MeDRA v14.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MeDRA v14.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MeDRA v14.0 | Non-systematic Assessment |
| |
| Syphilis | Infections and infestations | MeDRA v14.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MeDRA v14.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MeDRA v14.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D000077592 | Maraviroc |
| D061466 | Lopinavir |
| C558899 | lopinavir-ritonavir drug combination |
| D000068679 | Emtricitabine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
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