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CompletedNCT00734344Updated May 30, 2016Results posted

Pilot Study of Raltegravir/Truvada Versus Efavirenz/Truvada for Adults With Acute IV-1 Infection

An interventional study of Raltegravir and Efavirenz in Acute HIV Infection, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2016-05-30.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acute HIV Infection
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 18 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
18 participants (actual)

Study arms

  • Active comparator
    Arm 1

    Raltegravir plus Truvada

    Drug: Raltegravir · Drug: Emtricitibine · Drug: Tenofovir disoproxil twice daily

  • Active comparator
    Arm 2

    Efavirenz plus Truvada

    Drug: Efavirenz · Drug: Emtricitibine · Drug: Tenofovir disoproxil once daily

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

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

07

Results

Posted May 30, 2016

Participant flow

Participant flow — Overall Study
MilestoneArm 1Arm 2
Started99
Completed99
Not completed00

Outcome measures

PrimaryMean 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
Reported as:
Mean · white blood cells per microliter (mcL).
Mean White Blood Cell Count Between Treatment Groups at 2 Months
white blood cells per microliter (mcL).Raltegravir Plus TruvadaEfavirenz Plus Truvada
Mean White Blood Cell Count Between Treatment Groups at 2 Months5904 (2450 to 139600)4918 (2870 to 6650)
PrimaryMean 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
Reported as:
Mean · white blood cells per microliter (mcL).
Mean White Blood Cell Count Between Treatment Groups at 4 Months
white blood cells per microliter (mcL).Raltegravir Plus TruvadaEfavirenz Plus Truvada
Mean White Blood Cell Count Between Treatment Groups at 4 Months5850 (2840 to 12640)4948 (3230 to 6370)
PrimaryMean 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
Reported as:
Mean · white blood cells per microliter (mcL).
Mean White Blood Cell Count Between Treatment Groups at 6 Months
white blood cells per microliter (mcL).Raltegravir Plus TruvadaEfavirenz Plus Truvada
Mean White Blood Cell Count Between Treatment Groups at 6 Months5219 (2860 to 8630)4522 (3230 to 5530)
PrimaryMean 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
Reported as:
Mean · white blood cells per microliter (mcL).
Mean White Blood Cell Count Between Treatment Groups at 8 Months
white blood cells per microliter (mcL).Raltegravir Plus TruvadaEfavirenz Plus Truvada
Mean White Blood Cell Count Between Treatment Groups at 8 Months6240 (3540 to 10800)4607 (2820 to 5820)
PrimaryMean 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
Reported as:
Mean · white blood cells per microliter (mcL).
Mean White Blood Cell Count Between Treatment Groups at 10 Months
white blood cells per microliter (mcL).Raltegravir Plus TruvadaEfavirenz Plus Truvada
Mean White Blood Cell Count Between Treatment Groups at 10 Months5230 (5030 to 5430)4615 (4420 to 4810)
PrimaryMean 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
Reported as:
Mean · white blood cells per microliter (mcL).
Mean White Blood Cell Count Between Treatment Groups at 12 Months
white blood cells per microliter (mcL).Raltegravir Plus TruvadaEfavirenz Plus Truvada
Mean White Blood Cell Count Between Treatment Groups at 12 Months6320 (4950 to 7470)4868 (3980 to 5710)
PrimaryMean 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
Reported as:
Mean · white blood cells per microliter (mcL).
Mean White Blood Cell Count Between Treatment Groups at 14 Months
white blood cells per microliter (mcL).Raltegravir Plus TruvadaEfavirenz Plus Truvada
Mean White Blood Cell Count Between Treatment Groups at 14 Months3180 (3180 to 3180)4903 (4360 to 5840)
PrimaryMean 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
Reported as:
Mean · percentage
Mean Hematocrit Between Treatment Groups at 2 Months
percentageRaltegravir Plus TruvadaEfavirenz Plus Truvada
Mean Hematocrit Between Treatment Groups at 2 Months41.5 (36 to 46)41.8 (37 to 50)
PrimaryMean 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
Reported as:
Mean · percentage
Mean Hematocrit Between Treatment Groups at 4 Months
percentageRaltegravir Plus TruvadaEfavirenz Plus Truvada
Mean Hematocrit Between Treatment Groups at 4 Months41.4 (34 to 48)43 (37 to 51)
PrimaryMean 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
Reported as:
Mean · percentage
Mean Hematocrit Between Treatment Groups at 6 Months
percentageRaltegravir Plus TruvadaEfavirenz Plus Truvada
Mean Hematocrit Between Treatment Groups at 6 Months42.1 (36 to 47)39.8 (35 to 50)
PrimaryMean 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
Reported as:
Mean · percentage
Mean Hematocrit Between Treatment Groups at 8 Months
percentageRaltegravir Plus TruvadaEfavirenz Plus Truvada
Mean Hematocrit Between Treatment Groups at 8 Months40.3 (37 to 45)41.2 (36 to 51)
PrimaryMean 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
Reported as:
Mean · percentage
Mean Hematocrit Between Treatment Groups at 10 Months
percentageRaltegravir Plus TruvadaEfavirenz Plus Truvada
Mean Hematocrit Between Treatment Groups at 10 Months45 (42 to 48)38 (37 to 39)
PrimaryMean 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
Reported as:
Mean · percentage
Mean Hematocrit Between Treatment Groups at 12 Months
percentageRaltegravir Plus TruvadaEfavirenz Plus Truvada
Mean Hematocrit Between Treatment Groups at 12 Months41 (37 to 45)43.5 (39 to 52)
PrimaryMean 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
Reported as:
Mean · percentage
Mean Hematocrit Between Treatment Groups at 14 Months
percentageRaltegravir Plus TruvadaEfavirenz Plus Truvada
Mean Hematocrit Between Treatment Groups at 14 Months36 (36 to 36)39.7 (39 to 40)
PrimaryMean 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
Reported as:
Mean · count per microliter
Mean Platelet Count Between Treatment Groups at 2 Months
count per microliterRaltegravir Plus TruvadaEfavirenz Plus Truvada
Mean Platelet Count Between Treatment Groups at 2 Months232600 (166200 to 336100)225600 (154700 to 306800)
PrimaryMean 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
Reported as:
Mean · count per microliter
Mean Platelet Count Between Treatment Groups at 4 Months
count per microliterRaltegravir Plus TruvadaEfavirenz Plus Truvada
Mean Platelet Count Between Treatment Groups at 4 Months210800 (157600 to 343200)197300 (144600 to 263900)
PrimaryMean 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
Reported as:
Mean · count per microliter
Mean Platelet Count Between Treatment Groups at 6 Months
count per microliterRaltegravir Plus TruvadaEfavirenz Plus Truvada
Mean Platelet Count Between Treatment Groups at 6 Months230000 (162600 to 307000)224800 (129700 to 309100)
PrimaryMean 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
Reported as:
Mean · count per microliter
Mean Platelet Count Between Treatment Groups at 8 Months
count per microliterRaltegravir Plus TruvadaEfavirenz Plus Truvada
Mean Platelet Count Between Treatment Groups at 8 Months215700 (108000 to 333200)208100 (131200 to 265900)
PrimaryMean 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
Reported as:
Mean · count per microliter
Mean Platelet Count Between Treatment Groups at 10 Months
count per microliterRaltegravir Plus TruvadaEfavirenz Plus Truvada
Mean Platelet Count Between Treatment Groups at 10 Months193500 (187600 to 199500)243300 (196600 to 290100)
PrimaryMean 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
Reported as:
Mean · count per microliter
Mean Platelet Count Between Treatment Groups at 12 Months
count per microliterRaltegravir Plus TruvadaEfavirenz Plus Truvada
Mean Platelet Count Between Treatment Groups at 12 Months255600 (207700 to 318600)185500 (144600 to 216900)
PrimaryMean 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
Reported as:
Mean · count per microliter
Mean Platelet Count Between Treatment Groups at 14 Months
count per microliterRaltegravir Plus TruvadaEfavirenz Plus Truvada
Mean Platelet Count Between Treatment Groups at 14 Months217400 (217400 to 217400)216800 (191400 to 247000)
PrimaryMean 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
Reported as:
Mean · cells/mm3
Mean CD4 Count Between Treatment Groups at 1 Months
cells/mm3Raltegravir Plus TruvadaEfavirenz Plus Truvada
Mean CD4 Count Between Treatment Groups at 1 Months629.1 (345 to 1157)535 (370 to 773)
PrimaryMean 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
Reported as:
Mean · cells/mm3
Mean CD4 Count Between Treatment Groups at 2 Months
cells/mm3Raltegravir Plus TruvadaEfavirenz Plus Truvada
Mean CD4 Count Between Treatment Groups at 2 Months703.1 (300 to 1541)527.2 (336 to 787)
PrimaryMean 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
Reported as:
Mean · cells/mm3
Mean CD4 Count Between Treatment Groups at 3 Months
cells/mm3Raltegravir Plus TruvadaEfavirenz Plus Truvada
Mean CD4 Count Between Treatment Groups at 3 Months716.4 (399 to 1251)671.7 (485 to 903)
PrimaryMean 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
Reported as:
Mean · cells/mm3
Mean CD4 Count Between Treatment Groups at 4 Months
cells/mm3Raltegravir Plus TruvadaEfavirenz Plus Truvada
Mean CD4 Count Between Treatment Groups at 4 Months617.2 (362 to 901)646.5 (589 to 704)
PrimaryMean 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
Reported as:
Mean · cells/mm3
Mean CD4 Count Between Treatment Groups at 5 Months
cells/mm3Raltegravir Plus TruvadaEfavirenz Plus Truvada
Mean CD4 Count Between Treatment Groups at 5 Months805.7 (446 to 1991)539.6 (386 to 711)
PrimaryMean 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
Reported as:
Mean · cells/mm3
Mean CD4 Count Between Treatment Groups at 6 Months
cells/mm3Raltegravir Plus TruvadaEfavirenz Plus Truvada
Mean CD4 Count Between Treatment Groups at 6 Months652.2 (435 to 986)673.5 (665 to 682)
PrimaryMean 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
Reported as:
Mean · cells/mm3
Mean CD4 Count Between Treatment Groups at 7 Months
cells/mm3Raltegravir Plus TruvadaEfavirenz Plus Truvada
Mean CD4 Count Between Treatment Groups at 7 Months504 (300 to 662)552.5 (467 to 638)
PrimaryMean 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
Reported as:
Mean · cells/mm3
Mean CD4 Count Between Treatment Groups at 8 Months
cells/mm3Raltegravir Plus TruvadaEfavirenz Plus Truvada
Mean CD4 Count Between Treatment Groups at 8 Months464.5 (365 to 628)586.5 (485 to 688)
PrimaryMean 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
Reported as:
Mean · cells/mm3
Mean CD4 Count Between Treatment Groups at 9 Months
cells/mm3Raltegravir Plus TruvadaEfavirenz Plus Truvada
Mean CD4 Count Between Treatment Groups at 9 Months306 (306 to 306)571 (571 to 571)
PrimaryMean 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
Reported as:
Mean · cells/mm3
Mean CD4 Count Between Treatment Groups at 10 Months
cells/mm3Raltegravir Plus TruvadaEfavirenz Plus Truvada
Mean CD4 Count Between Treatment Groups at 10 Months469 (469 to 469)571.5 (561 to 582)
PrimaryMean 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
Reported as:
Mean · cells/mm3
Mean CD4 Count Between Treatment Groups at 11 Months
cells/mm3Raltegravir Plus TruvadaEfavirenz Plus Truvada
Mean CD4 Count Between Treatment Groups at 11 Months495 (495 to 495)—

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm 1—0/9 (0%)0/9 (0%)
Arm 2—0/9 (0%)0/9 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Arm 1Arm 2Total
<=18 years000
Between 18 and 65 years9918
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)Arm 1Arm 2Total
Female022
Male9716
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Arm 1Arm 2Total
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American448
White5510
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Arm 1Arm 2Total
United States9918
08

Study locations

1 site
  • UAB 1917 Clinic
    Birmingham, Alabama 35294, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00734344
Lead sponsor
University of Alabama at Birmingham
Collaborators
Merck Sharp & Dohme LLC
Responsible party
Sonya Heath, MD (Principal Investigator, University of Alabama at Birmingham) — Principal investigator
First posted
Aug 14, 2008
Start date
Sep 2008
Primary completion
Aug 2012
Completion
Sep 2012
Results posted
May 30, 2016
Last update
May 30, 2016

Study contacts

Sonya Heath, M. D.
principal investigator · Department of Medicine Divison of Infectious Disease

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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