Acute HIV Infection
Conditions
Brief summary
This is a single-site, investigator-initiated, open-label, randomized/controlled clinical trial to compare the viral load response in plasma (and, in a subset of subjects, in gastrointestinal lymphoid tissue reservoirs) in subjects with acute/early HIV-1 infection treated with 12 weeks of raltegravir-based versus efavirenz-based ART (each combined with tenofovir/emtricitabine). Subjects will receive a self-limited course of therapy rather than a commitment to life-long HAART, as has been the experimental approach in a variety of clinical protocols in the United States and Europe. Subjects will complete a 12 week course of therapy, and those who meet treatment-response and safety criteria will then undergo a similarly intensive period of virology and immunology monitoring to compare the timing and dynamics of any observed virologic rebound following the treatment intervention.
Interventions
DRUGRaltegravir
Raltegravir 400 mg. BID
DRUGEfavirenz
600 mg once daily
DRUGEmtricitibine
200mg once daily
DRUGTenofovir disoproxil once daily
300mg once daily
DRUGTenofovir disoproxil twice daily
300mg twice daily
Sponsors
Merck Sharp & Dohme LLC
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects 19 years of age or older who meet the NIH Acute Infection and Early Disease Research Program (AIEDRP) definition of acute or early HIV-1 infection. Briefly, acute HIV-1 infection is defined as \> 5000 copies per milliliter of HIV RNA and one of the following documented within a 7 day period of the initial positive PCR-based assay: 1) a negative HIV-1 EIA or 2) a positive EIA with a negative or indeterminant HIV-1 Western Blot test (interpreted based on current CDC guidelines). For the purposes of this protocol, early HIV-1 infection is defined as detectable HIV RNA by PCR-based assay, a positive HIV EIA, a positive HIV-1 Western blot, and one of the following: 1) a documented negative HIV EIA in the preceding 6 months or 2) an HIV detuned EIA standardized optical density measurement (defined as sample OD - negative control OD/ positive control OD) of \< 1.0 within 14 days of the positive HIV EIA (consistent with acute infection occurring in the past 120 days).
Exclusion criteria
* Lack consistent evidence of seroconversion or documented appropriate antibody testing for persistent HIV infection during the screening and early follow-up period. * Prior receipt of antiretroviral therapy. * Serum creatinine \> 2.0 x upper limit of normal or a calculated creatinine clearance at time of screening \< 30 mL/min (and 0.85X this value for females). * Alkaline phosphatase \>5 x upper limit of normal. * AST (SGOT) and ALT (SGPT) \> 5 x upper limit of normal. Repeat of a laboratory screening test will be allowed for test results that are unexpected based on documented prior laboratory results or to monitor declining trends that may relate to the primary retroviral syndrome. * Have any severe medical illness that the investigators feel will interfere with the ability to take therapy or that will result in making therapy too risky for the subject. This includes active tuberculosis treatment, severe liver disease due to alcoholism or viral hepatitis, or unstable cardiovascular or cerebrovascular disease. * Have significant psychiatric illness or ongoing substance abuse that, in the opinion of the investigators, would compromise the ability of the subject to provide adequate informed consent or to adhere to the study procedures safely and consistently. * Women who are pregnant or actively breastfeeding at the time of screening. * Men or women who are actively attempting to become pregnant, or who are unable or unwilling to institute adequate birth control measures during the entire course of this treatment protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean White Blood Cell Count Between Treatment Groups at 2 Months | baseline to 2 months | Mean WBC count for all subjects as determined by standard lab procedures at 2 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL). |
| Mean White Blood Cell Count Between Treatment Groups at 4 Months | 4 months post baseline | Mean WBC count of all subjects as determined by standard lab procedures at 4 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL). |
| Mean White Blood Cell Count Between Treatment Groups at 6 Months | 6 months after baseline | Mean WBC count of all subjects as determined by standard lab procedures at 6 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL). |
| Mean White Blood Cell Count Between Treatment Groups at 12 Months | 12 months after baseline | Mean WBC count of all subjects as determined by standard lab procedures at 12 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL). |
| Mean White Blood Cell Count Between Treatment Groups at 8 Months | 8 months after baseline | Mean WBC count of all subjects as determined by standard lab procedures at 8 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL). |
| Mean White Blood Cell Count Between Treatment Groups at 10 Months | 10 months after baseline | Mean WBC count of all subjects as determined by standard lab procedures at 10 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL). |
| Mean White Blood Cell Count Between Treatment Groups at 14 Months | 14 months after baseline | Mean WBC count of all subjects as determined by standard lab procedures at 14 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL). |
| Mean Hematocrit Between Treatment Groups at 2 Months | 2 months after baseline | Mean hematocrit of all subjects at 2 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women. |
| Mean Hematocrit Between Treatment Groups at 4 Months | 4 months after baseline | Mean hematocrit of all subjects at 4 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women. |
| Mean Hematocrit Between Treatment Groups at 6 Months | 6 months after baseline | Mean hematocrit of all subjects at 6 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women. |
| Mean Hematocrit Between Treatment Groups at 8 Months | 8 months after baseline | Mean hematocrit of all subjects at 8 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women. |
| Mean Hematocrit Between Treatment Groups at 10 Months | 10 months after baseline | Mean hematocrit of all subjects at 10 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women. |
| Mean Hematocrit Between Treatment Groups at 12 Months | 12 months after baseline | Mean hematocrit of all subjects at 12 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women. |
| Mean Hematocrit Between Treatment Groups at 14 Months | 14 months after baseline | Mean hematocrit of all subjects at 14 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women. |
| Mean Platelet Count Between Treatment Groups at 2 Months | 2 months after baseline | The mean platelet count between treament groups at 2 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 100 per liter). |
| Mean Platelet Count Between Treatment Groups at 4 Months | 4 months after baseline | The mean platelet count between treatment groups at 4 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter). |
| Mean Platelet Count Between Treatment Groups at 6 Months | 6 months after baseline | The mean platelet count between treatment groups at 6 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter). |
| Mean Platelet Count Between Treatment Groups at 8 Months | 8 months after baseline | The mean platelet count between treatment groups at 8 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter). |
| Mean Platelet Count Between Treatment Groups at 10 Months | 10 months after baseline | The mean platelet count between treatment groups at 10 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter). |
| Mean Platelet Count Between Treatment Groups at 12 Months | 12 months after baseline | The mean platelet count between treatment groups at 12 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter). |
| Mean Platelet Count Between Treatment Groups at 14 Months | 4 months after baseline | The mean platelet count between treatment groups at 14 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter). |
| Mean CD4 Count Between Treatment Groups at 1 Months | 1 month after baseline | Mean CD4 count between groups 1 month after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). |
| Mean CD4 Count Between Treatment Groups at 2 Months | 2 months after baseline | Mean CD4 count between groups 2 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). |
| Mean CD4 Count Between Treatment Groups at 3 Months | 3 months after baseline | Mean CD4 count between groups 3 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). |
| Mean CD4 Count Between Treatment Groups at 4 Months | 4 months after baseline | Mean CD4 count between groups 4 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). |
| Mean CD4 Count Between Treatment Groups at 5 Months | 5 months after baseline | Mean CD4 count between groups 5 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). |
| Mean CD4 Count Between Treatment Groups at 6 Months | 6 months after baseline | Mean CD4 count between groups 6 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). |
| Mean CD4 Count Between Treatment Groups at 7 Months | 7 months after baseline | Mean CD4 count between groups 7 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). |
| Mean CD4 Count Between Treatment Groups at 8 Months | 8 months after baseline | Mean CD4 count between groups 8 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). |
| Mean CD4 Count Between Treatment Groups at 9 Months | 9 months after baseline | Mean CD4 count between groups 9 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). |
| Mean CD4 Count Between Treatment Groups at 10 Months | 10 months after baseline | Mean CD4 count between groups 10 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). |
| Mean CD4 Count Between Treatment Groups at 11 Months | 11 months after baseline | Mean CD4 count between groups 11 months after of starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 Raltegravir plus Truvada
Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily | 9 |
| Arm 2 Efavirenz plus Truvada
Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily | 9 |
| Total | 18 |
Baseline characteristics
| Characteristic | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 9 Participants | 18 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 5 Participants | 10 Participants |
| Region of Enrollment United States | 9 participants | 9 participants | 18 participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 9 Participants | 7 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 9 | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 |
Outcome results
Primary
Mean CD4 Count Between Treatment Groups at 10 Months
Mean CD4 count between groups 10 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).
Time frame: 10 months after baseline
Population: In the Raltegravir plus Truvada arm, there was no data for 8 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean CD4 Count Between Treatment Groups at 10 Months | 469 cells/mm3 |
| Efavirenz Plus Truvada | Mean CD4 Count Between Treatment Groups at 10 Months | 571.5 cells/mm3 |
Primary
Mean CD4 Count Between Treatment Groups at 11 Months
Mean CD4 count between groups 11 months after of starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).
Time frame: 11 months after baseline
Population: In the Raltegravir plus Truvada arm, there was no data for 9 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 9 subjects because either the subjects missed a visit or chose not to stop therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean CD4 Count Between Treatment Groups at 11 Months | 495 cells/mm3 |
Primary
Mean CD4 Count Between Treatment Groups at 1 Months
Mean CD4 count between groups 1 month after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).
Time frame: 1 month after baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean CD4 Count Between Treatment Groups at 1 Months | 629.1 cells/mm3 |
| Efavirenz Plus Truvada | Mean CD4 Count Between Treatment Groups at 1 Months | 535 cells/mm3 |
Primary
Mean CD4 Count Between Treatment Groups at 2 Months
Mean CD4 count between groups 2 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).
Time frame: 2 months after baseline
Population: In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 1 subject because either the subjects missed a visit or chose not to stop therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean CD4 Count Between Treatment Groups at 2 Months | 703.1 cells/mm3 |
| Efavirenz Plus Truvada | Mean CD4 Count Between Treatment Groups at 2 Months | 527.2 cells/mm3 |
Primary
Mean CD4 Count Between Treatment Groups at 3 Months
Mean CD4 count between groups 3 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).
Time frame: 3 months after baseline
Population: In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 3 subjects because either the subjects missed a visit or chose not to stop therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean CD4 Count Between Treatment Groups at 3 Months | 716.4 cells/mm3 |
| Efavirenz Plus Truvada | Mean CD4 Count Between Treatment Groups at 3 Months | 671.7 cells/mm3 |
Primary
Mean CD4 Count Between Treatment Groups at 4 Months
Mean CD4 count between groups 4 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).
Time frame: 4 months after baseline
Population: In the Raltegravir plus Truvada arm, there was no data for 4 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean CD4 Count Between Treatment Groups at 4 Months | 617.2 cells/mm3 |
| Efavirenz Plus Truvada | Mean CD4 Count Between Treatment Groups at 4 Months | 646.5 cells/mm3 |
Primary
Mean CD4 Count Between Treatment Groups at 5 Months
Mean CD4 count between groups 5 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).
Time frame: 5 months after baseline
Population: In the Raltegravir plus Truvada arm, there was no data for 3 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean CD4 Count Between Treatment Groups at 5 Months | 805.7 cells/mm3 |
| Efavirenz Plus Truvada | Mean CD4 Count Between Treatment Groups at 5 Months | 539.6 cells/mm3 |
Primary
Mean CD4 Count Between Treatment Groups at 6 Months
Mean CD4 count between groups 6 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).
Time frame: 6 months after baseline
Population: In the Raltegravir plus Truvada arm, there was no data for 4 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean CD4 Count Between Treatment Groups at 6 Months | 652.2 cells/mm3 |
| Efavirenz Plus Truvada | Mean CD4 Count Between Treatment Groups at 6 Months | 673.5 cells/mm3 |
Primary
Mean CD4 Count Between Treatment Groups at 7 Months
Mean CD4 count between groups 7 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).
Time frame: 7 months after baseline
Population: In the Raltegravir plus Truvada arm, there was no data for 5 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean CD4 Count Between Treatment Groups at 7 Months | 504 cells/mm3 |
| Efavirenz Plus Truvada | Mean CD4 Count Between Treatment Groups at 7 Months | 552.5 cells/mm3 |
Primary
Mean CD4 Count Between Treatment Groups at 8 Months
Mean CD4 count between groups 8 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).
Time frame: 8 months after baseline
Population: In the Raltegravir plus Truvada arm, there was no data for 5 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean CD4 Count Between Treatment Groups at 8 Months | 464.5 cells/mm3 |
| Efavirenz Plus Truvada | Mean CD4 Count Between Treatment Groups at 8 Months | 586.5 cells/mm3 |
Primary
Mean CD4 Count Between Treatment Groups at 9 Months
Mean CD4 count between groups 9 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).
Time frame: 9 months after baseline
Population: In the Raltegravir plus Truvada arm, there was no data for 8 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 8 subjects because either the subjects missed a visit or chose not to stop therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean CD4 Count Between Treatment Groups at 9 Months | 306 cells/mm3 |
| Efavirenz Plus Truvada | Mean CD4 Count Between Treatment Groups at 9 Months | 571 cells/mm3 |
Primary
Mean Hematocrit Between Treatment Groups at 10 Months
Mean hematocrit of all subjects at 10 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.
Time frame: 10 months after baseline
Population: In the Raltegravir plus Truvada arm, there was no data for 7 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean Hematocrit Between Treatment Groups at 10 Months | 45 percentage |
| Efavirenz Plus Truvada | Mean Hematocrit Between Treatment Groups at 10 Months | 38 percentage |
Primary
Mean Hematocrit Between Treatment Groups at 12 Months
Mean hematocrit of all subjects at 12 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.
Time frame: 12 months after baseline
Population: In the Raltegravir plus Truvada arm, there was no data for 6 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 5 subjects because either the subjects missed a visit or chose not to stop therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean Hematocrit Between Treatment Groups at 12 Months | 41 percentage |
| Efavirenz Plus Truvada | Mean Hematocrit Between Treatment Groups at 12 Months | 43.5 percentage |
Primary
Mean Hematocrit Between Treatment Groups at 14 Months
Mean hematocrit of all subjects at 14 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.
Time frame: 14 months after baseline
Population: In the Raltegravir plus Truvada arm, there was no data for 8 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 6 subjects because either the subjects missed a visit or chose not to stop therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean Hematocrit Between Treatment Groups at 14 Months | 36 percentage |
| Efavirenz Plus Truvada | Mean Hematocrit Between Treatment Groups at 14 Months | 39.7 percentage |
Primary
Mean Hematocrit Between Treatment Groups at 2 Months
Mean hematocrit of all subjects at 2 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.
Time frame: 2 months after baseline
Population: In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean Hematocrit Between Treatment Groups at 2 Months | 41.5 percentage |
| Efavirenz Plus Truvada | Mean Hematocrit Between Treatment Groups at 2 Months | 41.8 percentage |
Primary
Mean Hematocrit Between Treatment Groups at 4 Months
Mean hematocrit of all subjects at 4 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.
Time frame: 4 months after baseline
Population: In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean Hematocrit Between Treatment Groups at 4 Months | 41.4 percentage |
| Efavirenz Plus Truvada | Mean Hematocrit Between Treatment Groups at 4 Months | 43 percentage |
Primary
Mean Hematocrit Between Treatment Groups at 6 Months
Mean hematocrit of all subjects at 6 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.
Time frame: 6 months after baseline
Population: In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean Hematocrit Between Treatment Groups at 6 Months | 42.1 percentage |
| Efavirenz Plus Truvada | Mean Hematocrit Between Treatment Groups at 6 Months | 39.8 percentage |
Primary
Mean Hematocrit Between Treatment Groups at 8 Months
Mean hematocrit of all subjects at 8 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.
Time frame: 8 months after baseline
Population: In the Raltegravir plus Truvada arm, there was no data for 3 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 3 subjects because either the subjects missed a visit or chose not to stop therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean Hematocrit Between Treatment Groups at 8 Months | 40.3 percentage |
| Efavirenz Plus Truvada | Mean Hematocrit Between Treatment Groups at 8 Months | 41.2 percentage |
Primary
Mean Platelet Count Between Treatment Groups at 10 Months
The mean platelet count between treatment groups at 10 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).
Time frame: 10 months after baseline
Population: In the Raltegravir plus Truvada arm, there was no data for 7 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean Platelet Count Between Treatment Groups at 10 Months | 193500 count per microliter |
| Efavirenz Plus Truvada | Mean Platelet Count Between Treatment Groups at 10 Months | 243300 count per microliter |
Primary
Mean Platelet Count Between Treatment Groups at 12 Months
The mean platelet count between treatment groups at 12 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).
Time frame: 12 months after baseline
Population: In the Raltegravir plus Truvada arm, there was no data for 6 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 5 subjects because either the subjects missed a visit or chose not to stop therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean Platelet Count Between Treatment Groups at 12 Months | 255600 count per microliter |
| Efavirenz Plus Truvada | Mean Platelet Count Between Treatment Groups at 12 Months | 185500 count per microliter |
Primary
Mean Platelet Count Between Treatment Groups at 14 Months
The mean platelet count between treatment groups at 14 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).
Time frame: 4 months after baseline
Population: In the Raltegravir plus Truvada arm, there was no data for 8 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 6 subjects because either the subjects missed a visit or chose not to stop therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean Platelet Count Between Treatment Groups at 14 Months | 217400 count per microliter |
| Efavirenz Plus Truvada | Mean Platelet Count Between Treatment Groups at 14 Months | 216800 count per microliter |
Primary
Mean Platelet Count Between Treatment Groups at 2 Months
The mean platelet count between treament groups at 2 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 100 per liter).
Time frame: 2 months after baseline
Population: In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean Platelet Count Between Treatment Groups at 2 Months | 232600 count per microliter |
| Efavirenz Plus Truvada | Mean Platelet Count Between Treatment Groups at 2 Months | 225600 count per microliter |
Primary
Mean Platelet Count Between Treatment Groups at 4 Months
The mean platelet count between treatment groups at 4 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).
Time frame: 4 months after baseline
Population: In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean Platelet Count Between Treatment Groups at 4 Months | 210800 count per microliter |
| Efavirenz Plus Truvada | Mean Platelet Count Between Treatment Groups at 4 Months | 197300 count per microliter |
Primary
Mean Platelet Count Between Treatment Groups at 6 Months
The mean platelet count between treatment groups at 6 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).
Time frame: 6 months after baseline
Population: In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean Platelet Count Between Treatment Groups at 6 Months | 230000 count per microliter |
| Efavirenz Plus Truvada | Mean Platelet Count Between Treatment Groups at 6 Months | 224800 count per microliter |
Primary
Mean Platelet Count Between Treatment Groups at 8 Months
The mean platelet count between treatment groups at 8 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).
Time frame: 8 months after baseline
Population: In the Raltegravir plus Truvada arm, there was no data for 3 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 3 subjects because either the subjects missed a visit or chose not to stop therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean Platelet Count Between Treatment Groups at 8 Months | 215700 count per microliter |
| Efavirenz Plus Truvada | Mean Platelet Count Between Treatment Groups at 8 Months | 208100 count per microliter |
Primary
Mean White Blood Cell Count Between Treatment Groups at 10 Months
Mean WBC count of all subjects as determined by standard lab procedures at 10 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).
Time frame: 10 months after baseline
Population: In the Raltegravir plus Truvada arm, there was no data for 7 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean White Blood Cell Count Between Treatment Groups at 10 Months | 5230 white blood cells per microliter (mcL). |
| Efavirenz Plus Truvada | Mean White Blood Cell Count Between Treatment Groups at 10 Months | 4615 white blood cells per microliter (mcL). |
Primary
Mean White Blood Cell Count Between Treatment Groups at 12 Months
Mean WBC count of all subjects as determined by standard lab procedures at 12 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).
Time frame: 12 months after baseline
Population: In the Raltegravir plus Truvada arm, there was no data for 6 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 5 subjects because either the subjects missed a visit or chose not to stop therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean White Blood Cell Count Between Treatment Groups at 12 Months | 6320 white blood cells per microliter (mcL). |
| Efavirenz Plus Truvada | Mean White Blood Cell Count Between Treatment Groups at 12 Months | 4868 white blood cells per microliter (mcL). |
Primary
Mean White Blood Cell Count Between Treatment Groups at 14 Months
Mean WBC count of all subjects as determined by standard lab procedures at 14 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).
Time frame: 14 months after baseline
Population: In the Raltegravir plus Truvada arm, there was no data for 8 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 6 subjects because either the subjects missed a visit or chose not to stop therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean White Blood Cell Count Between Treatment Groups at 14 Months | 3180 white blood cells per microliter (mcL). |
| Efavirenz Plus Truvada | Mean White Blood Cell Count Between Treatment Groups at 14 Months | 4903 white blood cells per microliter (mcL). |
Primary
Mean White Blood Cell Count Between Treatment Groups at 2 Months
Mean WBC count for all subjects as determined by standard lab procedures at 2 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).
Time frame: baseline to 2 months
Population: Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean White Blood Cell Count Between Treatment Groups at 2 Months | 5904 white blood cells per microliter (mcL). |
| Efavirenz Plus Truvada | Mean White Blood Cell Count Between Treatment Groups at 2 Months | 4918 white blood cells per microliter (mcL). |
Primary
Mean White Blood Cell Count Between Treatment Groups at 4 Months
Mean WBC count of all subjects as determined by standard lab procedures at 4 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).
Time frame: 4 months post baseline
Population: In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 3 subjects because either the subjects missed a visit or chose not to stop therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean White Blood Cell Count Between Treatment Groups at 4 Months | 5850 white blood cells per microliter (mcL). |
| Efavirenz Plus Truvada | Mean White Blood Cell Count Between Treatment Groups at 4 Months | 4948 white blood cells per microliter (mcL). |
Primary
Mean White Blood Cell Count Between Treatment Groups at 6 Months
Mean WBC count of all subjects as determined by standard lab procedures at 6 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).
Time frame: 6 months after baseline
Population: In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean White Blood Cell Count Between Treatment Groups at 6 Months | 5219 white blood cells per microliter (mcL). |
| Efavirenz Plus Truvada | Mean White Blood Cell Count Between Treatment Groups at 6 Months | 4522 white blood cells per microliter (mcL). |
Primary
Mean White Blood Cell Count Between Treatment Groups at 8 Months
Mean WBC count of all subjects as determined by standard lab procedures at 8 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).
Time frame: 8 months after baseline
Population: In the Raltegravir plus Truvada arm, there was no data for 3 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Raltegravir Plus Truvada | Mean White Blood Cell Count Between Treatment Groups at 8 Months | 6240 white blood cells per microliter (mcL). |
| Efavirenz Plus Truvada | Mean White Blood Cell Count Between Treatment Groups at 8 Months | 4607 white blood cells per microliter (mcL). |