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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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This is a pilot that will evaluate two regimens for treating HIV infected patients that haven't been on treatment before. HIV/AIDS patients may have an increased risk of myocardial infarction and antiretroviral therapy used may contribute to this. We will evaluate virological, immunological and cardiovascular effects of two HIV treatment regimens.
We will check blood studies used to evaluate HIV patients response to therapy including CD4 count and HIV viral load test. We will check routine safety labs done on HIV patients and also check homocysteine levels and creatine kinase level. We will evaluate homocysteine and IL6 levels at baseline, week 48, and week 96.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Raltegravir | Active Comparator | Raltegravir in combination with truvada (tenofovir and emtricitabine) |
|
| Atazanavir | Active Comparator | Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raltegravir and truvada | Drug | Raltegravir 400 mg po bid, truvada 1 tab q daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in CD4 Count at 48 Weeks | Baseline and 48 weeks | |
| Change From Baseline in Log HIV Viral Load at 48 Weeks | Baseline and 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Lipids at 48 Weeks | Baseline and 48 weeks | |
| Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks | Baseline and 48 weeks | |
| Change From Baseline in Homocysteine at 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tanvir K Bell, MD | UT-Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Street Clinic | Houston | Texas | 77009 | United States |
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| Label | URL |
|---|---|
| open access journal | View source |
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approached patients HIV positive, naive to therapy, single site, English and Spanish speaking/writing.
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| ID | Title | Description |
|---|---|---|
| FG000 | Raltegravir | Raltegravir in combination with truvada (tenofovir and emtricitabine) Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily |
| FG001 | Atazanavir |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Atazanavir, Norvir and Truvada | Drug | Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily |
|
|
| Baseline and 48 weeks |
Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)
Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Raltegravir | Raltegravir in combination with truvada (tenofovir and emtricitabine) Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily |
| BG001 | Atazanavir | Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine) Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | year |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Change From Baseline in CD4 Count at 48 Weeks | Posted | Mean | Standard Deviation | cells/uL | Baseline and 48 weeks |
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| Secondary | Change From Baseline in Lipids at 48 Weeks | Posted | Mean | Standard Deviation | mg/dL | Baseline and 48 weeks |
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| Primary | Change From Baseline in Log HIV Viral Load at 48 Weeks | Posted | Mean | Standard Deviation | copies/mL | Baseline and 48 weeks |
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| Secondary | Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks | Posted | Mean | Standard Deviation | pg/mL | Baseline and 48 weeks |
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| Secondary | Change From Baseline in Homocysteine at 6 Months | Posted | Mean | Standard Deviation | umol/L | Baseline and 48 weeks |
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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 | Raltegravir | Raltegravir in combination with truvada (tenofovir and emtricitabine) Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily | 1 | 14 | 0 | 0 | ||
| EG001 | Atazanavir | Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine) Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily | 0 | 14 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| MAI infection, multi-organ failure, death | Renal and urinary disorders | Systematic Assessment |
|
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Limitations are the relatively small sample size and loss to follow-up. Medical records of patients that were lost to follow up was reviewed to ensure that no SAE occurred. We also attempted multiple times to contact patients.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tanvir Bell, MD | UT Health Science Center Houston | 713-500-6759 | Tanvir.K.Bell@uth.tmc.edu |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| 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 |
| D012897 | Slow Virus Diseases |
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| ID | Term |
|---|---|
| D000068898 | Raltegravir Potassium |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| D000068679 | Emtricitabine |
| D000069446 | Atazanavir Sulfate |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D011725 | Pyridines |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
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| >=65 years |
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| Male |
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