Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017032-41 | EudraCT Number |
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The purpose of this study is to determine whether HIV-1-infected patients, who are virologically suppressed on a regimen of 2 nucleoside reverse transcriptase inhibitors plus any third agent but are experiencing safety and/or tolerability issues, will maintain virologic suppression after switching to a regimen of heat-stable ritonavir boosted atazanavir, 300/100 mg, once daily plus raltegravir, 400 mg, twice daily.
Allocation: Randomized nonstratified
Intervention model: Parallel versus comparator
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atazanavir/Ritonavir + Raltegravir | Experimental | Atazanavir + Ritonavir (heat-stable) + Raltegravir |
|
| Atazanavir/Ritonavir + Tenofovir/Emtricitabine | Other | Reference Atazanavir + Ritonavir (heat-stable) + Tenofovir/Emtricitabine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atazanavir | Drug | Capsules, Oral, 300mg, Once daily, 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24 | HIV-1 RNA level was measured with the Abbott m2000rt® polymerase chain reaction assay. Response rates were assessed using an intent-to-treat algorithm, with numerator representing patients meeting the response criteria, and denominator representing all randomized patients. Randomized patients not meeting the criteria for treatment failure (eg, discontinuation of study therapy or virologic rebound at or before Week 24) were considered responders. Virologic rebound was defined as 2 consecutive on-treatment HIV-1 RNA levels ≥40 c/mL or the last on-treatment HIV-1 RNA level ≥40 c/mL followed by discontinuation. Patients who experienced treatment failure or had missing Week 24 HIV-1 RNA levels were considered failures. RNA=ribonucleic acid; HIV=human immunodeficiency virus. | From Day 1 to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48 | Percentages of patients with HIV-1 RNA levels <40 c/mL were summarized at each scheduled visit. Longitudinal plots were created to display proportion versus visit week through Weeks 24 and 48 with error bars representing 95% confidence intervals. | From Day 1 to Week 48 |
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Key Inclusion Criteria
Key Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Mayers Squibb | Bristol-Mayers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health For Life Clinic Pllc | Little Rock | Arkansas | 72207 | United States | ||
| Eisenhower Medical Center |
Of 132 patients enrolled, 109 were randomized to receive treatment, and 23 patients were not randomized for the following reasons: 10 did not meet study criteria; 5 withdrew consent; 3 were lost to follow-up, and 5 withdrew for other reasons.
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| ID | Title | Description |
|---|---|---|
| FG000 | Atazanavir/Ritonavir + Raltegravir | Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks. |
| FG001 | Atazanavir/Ritonavir + Tenofovir/Emtricitabine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Ritonavir (heat-stable) | Drug | Tablets, Oral, 100 mg, Once daily, 48 weeks |
|
|
| Raltegravir | Drug | Tablets, Oral, 400 mg, Twice daily, 48 weeks |
|
|
| Tenofovir/Emtricitabine | Drug | Tablets, Oral, 300/200 mg, Once daily, 48 weeks |
|
|
| Number of Participants With Virologic Rebound at Weeks 24 and 48 |
Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. |
| Day 1 to Weeks 28 and 48 |
| Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24 | Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients | Day 1 to Week 24 |
| Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48 | Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients | Day 1 to Week 48 |
| Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. | Day 1 to Week 48 |
| Mean Changes in Fasting Lipid Levels From Baseline to Week 48 | LD=low-density lipoprotein; HDL=high-density lipoprotein. | From Baseline to Week 48 |
| Palm Springs |
| California |
| 92264 |
| United States |
| Metropolis Medical Pc | San Francisco | California | 94109 | United States |
| Consultive Medicine | Daytona Beach | Florida | 32117 | United States |
| Orange County Health Dept. | Orlando | Florida | 32805 | United States |
| Triple O Medical Services, P.A. | West Palm Beach | Florida | 33401 | United States |
| The Research Institute | Springfield | Massachusetts | 01105 | United States |
| Aids Care | Rochester | New York | 14607 | United States |
| Local Institution | Paris | Cedex 12 | 75551 | France |
| Local Institution | Lyon | 69317 | France |
| Local Institution | Orléans | 45067 | France |
| Local Institution | Paris | 75020 | France |
| Local Institution | Paris | 75679 | France |
| Local Institution | Strasbourg | 67091 | France |
| Local Institution | Bochum | 44791 | Germany |
| Local Institution | Frankfurt | 60590 | Germany |
| Local Institution | Frankfurt am Main | 60311 | Germany |
| Local Institution | Hamburg | 20246 | Germany |
| Local Institution | Munich | 80336 | Germany |
| Local Institution | Genova | 16128 | Italy |
| Local Institution | Genova | 16132 | Italy |
| Local Institution | Milan | 20127 | Italy |
| Local Institution | Milan | 20142 | Italy |
| Local Institution | Roma | 00149 | Italy |
| Local Institution | Warsaw | 01-201 | Poland |
| Local Institution | Wroclaw | 50-136 | Poland |
| Local Institution | Alicante | 03010 | Spain |
| Local Institution | Barcelona | 08036 | Spain |
| Local Institution | Madrid | 28006 | Spain |
| Local Institution | Madrid | 28007 | Spain |
| Local Institution | Madrid | 28046 | Spain |
| Local Institution | Madrid | 28805 | Spain |
| Local Institution | London | Greater London | SW10 9EL | United Kingdom |
| Local Institution | Manchester | Greater Manchester | M8 5RB | United Kingdom |
| Local Institution | Brighton | BN2 1ES | United Kingdom |
| Local Institution | London | E9 6SR | United Kingdom |
| Local Institution | London | NW3 2QG | United Kingdom |
| Local Institution | Sheffield | S10 2RX | United Kingdom |
Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants who received study drug
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Atazanavir/Ritonavir + Raltegravir | Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks. |
| BG001 | Atazanavir/Ritonavir + Tenofovir/Emtricitabine | Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily 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 age | Mean | Standard Deviation | Years |
| ||||||||||||||
| Age, Continuous | Median age | Median | Full Range | Years |
| ||||||||||||||
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| Mean CD4 count | Mean | Standard Deviation | Cells/mm^3 |
| |||||||||||||||
| Median CD4 count | Median | Full Range | Cells/mm^3 |
| |||||||||||||||
| Cardiovascular disease risk factors | Hypertension=systolic blood pressure/diastolic blood pressure >140/90 mm Hg or patient was taking antihypertensive medication; family history of coronary heart disease=father, mother, or sibling (male <55 years of age, and mother <65 years of age). | Number | 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 HIV-1 RNA Level <40 c/mL at Week 24 | HIV-1 RNA level was measured with the Abbott m2000rt® polymerase chain reaction assay. Response rates were assessed using an intent-to-treat algorithm, with numerator representing patients meeting the response criteria, and denominator representing all randomized patients. Randomized patients not meeting the criteria for treatment failure (eg, discontinuation of study therapy or virologic rebound at or before Week 24) were considered responders. Virologic rebound was defined as 2 consecutive on-treatment HIV-1 RNA levels ≥40 c/mL or the last on-treatment HIV-1 RNA level ≥40 c/mL followed by discontinuation. Patients who experienced treatment failure or had missing Week 24 HIV-1 RNA levels were considered failures. RNA=ribonucleic acid; HIV=human immunodeficiency virus. | All patients who received study drug and who had an HIV-1 RNA measurement at the analysis week. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Day 1 to Week 24 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48 | Percentages of patients with HIV-1 RNA levels <40 c/mL were summarized at each scheduled visit. Longitudinal plots were created to display proportion versus visit week through Weeks 24 and 48 with error bars representing 95% confidence intervals. | All patients who received study drug and who had an HIV-1 RNA measurement at the analysis week. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Day 1 to Week 48 |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Virologic Rebound at Weeks 24 and 48 | Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. | All patients who received study drug and who had an HIV-1 RNA measurement at the analysis week. | Posted | Number | Participants | Day 1 to Weeks 28 and 48 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24 | Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients | Patients who received study drug, who had an HIV-1 RNA measurement at the analysis week and who experienced virologic rebound. | Posted | Number | Participants | Day 1 to Week 24 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48 | Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients | Participants with virologic rebound | Posted | Number | Participants | Day 1 to Week 48 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. | All participants who received study drug | Posted | Number | Particpants | Day 1 to Week 48 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Mean Changes in Fasting Lipid Levels From Baseline to Week 48 | LD=low-density lipoprotein; HDL=high-density lipoprotein. | All participants who received study drug | Posted | Mean | Standard Error | mg/dL | From Baseline to Week 48 |
|
|
Not provided
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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 | Atazanavir/Ritonavir + Raltegravir | Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks. | 4 | 72 | 27 | 72 | ||
| EG001 | Atazanavir/Ritonavir + Tenofovir/Emtricitabine | Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks. | 1 | 37 | 23 | 37 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cachexia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonia legionella | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperlactacidaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ocular icterus | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Gonorrhoea | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
| ID | Term |
|---|---|
| D000069446 | Atazanavir Sulfate |
| D019438 | Ritonavir |
| D000068898 | Raltegravir Potassium |
| D000068698 | Tenofovir |
| D000068679 | Emtricitabine |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| 65-85 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Hispanic |
|
| Unknown |
|
| Diabetes mellitus |
|
| Current smoker |
|
| Previous smoker |
|
| Family history of premature coronary heart disease |
|
|
|
|
Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks. |
|
|
Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
|
|
| Counts |
|---|
| Participants |
|
|
|