Trial Outcomes & Findings for Pilot Study of Raltegravir/Truvada Versus Efavirenz/Truvada for Adults With Acute IV-1 Infection (NCT NCT00734344)

NCT ID: NCT00734344

Last Updated: 2016-05-30

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 18 participants
• Primary outcome timeframe: baseline to 2 months
• Results posted on: 2016-05-30

Participant Flow

Participant milestones

Measure	Arm 1 Raltegravir plus Truvada Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Arm 2 Efavirenz plus Truvada Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Overall Study STARTED	9	9
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Arm 1 n=9 Participants Raltegravir plus Truvada Raltegravir, tenofovir, emtricitibine: Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Arm 2 n=9 Participants Efavirenz plus Truvada Efavirenz plus tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	9 participants n=7 Participants	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Raltegravir Plus Truvada n=8 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=9 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean White Blood Cell Count Between Treatment Groups at 2 Months	5904 white blood cells per microliter (mcL). Interval 2450.0 to 139600.0	4918 white blood cells per microliter (mcL). Interval 2870.0 to 6650.0

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Measure	Raltegravir Plus Truvada n=8 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=5 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean White Blood Cell Count Between Treatment Groups at 4 Months	5850 white blood cells per microliter (mcL). Interval 2840.0 to 12640.0	4948 white blood cells per microliter (mcL). Interval 3230.0 to 6370.0

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Measure	Raltegravir Plus Truvada n=8 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=5 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean White Blood Cell Count Between Treatment Groups at 6 Months	5219 white blood cells per microliter (mcL). Interval 2860.0 to 8630.0	4522 white blood cells per microliter (mcL). Interval 3230.0 to 5530.0

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Measure	Raltegravir Plus Truvada n=6 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=5 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean White Blood Cell Count Between Treatment Groups at 8 Months	6240 white blood cells per microliter (mcL). Interval 3540.0 to 10800.0	4607 white blood cells per microliter (mcL). Interval 2820.0 to 5820.0

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Measure	Raltegravir Plus Truvada n=2 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=2 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean White Blood Cell Count Between Treatment Groups at 10 Months	5230 white blood cells per microliter (mcL). Interval 5030.0 to 5430.0	4615 white blood cells per microliter (mcL). Interval 4420.0 to 4810.0

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Measure	Raltegravir Plus Truvada n=3 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=4 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean White Blood Cell Count Between Treatment Groups at 12 Months	6320 white blood cells per microliter (mcL). Interval 4950.0 to 7470.0	4868 white blood cells per microliter (mcL). Interval 3980.0 to 5710.0

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Measure	Raltegravir Plus Truvada n=1 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=3 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean White Blood Cell Count Between Treatment Groups at 14 Months	3180 white blood cells per microliter (mcL). Interval 3180.0 to 3180.0	4903 white blood cells per microliter (mcL). Interval 4360.0 to 5840.0

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Raltegravir Plus Truvada n=8 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=9 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean Hematocrit Between Treatment Groups at 2 Months	41.5 percentage Interval 36.0 to 46.0	41.8 percentage Interval 37.0 to 50.0

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Raltegravir Plus Truvada n=8 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=5 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean Hematocrit Between Treatment Groups at 4 Months	41.4 percentage Interval 34.0 to 48.0	43 percentage Interval 37.0 to 51.0

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Raltegravir Plus Truvada n=8 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=5 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean Hematocrit Between Treatment Groups at 6 Months	42.1 percentage Interval 36.0 to 47.0	39.8 percentage Interval 35.0 to 50.0

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Raltegravir Plus Truvada n=6 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=6 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean Hematocrit Between Treatment Groups at 8 Months	40.3 percentage Interval 37.0 to 45.0	41.2 percentage Interval 36.0 to 51.0

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Raltegravir Plus Truvada n=2 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=2 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean Hematocrit Between Treatment Groups at 10 Months	45 percentage Interval 42.0 to 48.0	38 percentage Interval 37.0 to 39.0

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Raltegravir Plus Truvada n=3 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=4 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean Hematocrit Between Treatment Groups at 12 Months	41 percentage Interval 37.0 to 45.0	43.5 percentage Interval 39.0 to 52.0

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Raltegravir Plus Truvada n=1 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=3 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean Hematocrit Between Treatment Groups at 14 Months	36 percentage Interval 36.0 to 36.0	39.7 percentage Interval 39.0 to 40.0

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Measure	Raltegravir Plus Truvada n=8 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=9 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean Platelet Count Between Treatment Groups at 2 Months	232600 count per microliter Interval 166200.0 to 336100.0	225600 count per microliter Interval 154700.0 to 306800.0

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Measure	Raltegravir Plus Truvada n=8 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=5 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean Platelet Count Between Treatment Groups at 4 Months	210800 count per microliter Interval 157600.0 to 343200.0	197300 count per microliter Interval 144600.0 to 263900.0

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Measure	Raltegravir Plus Truvada n=8 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=5 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean Platelet Count Between Treatment Groups at 6 Months	230000 count per microliter Interval 162600.0 to 307000.0	224800 count per microliter Interval 129700.0 to 309100.0

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Measure	Raltegravir Plus Truvada n=6 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=6 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean Platelet Count Between Treatment Groups at 8 Months	215700 count per microliter Interval 108000.0 to 333200.0	208100 count per microliter Interval 131200.0 to 265900.0

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Measure	Raltegravir Plus Truvada n=2 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=2 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean Platelet Count Between Treatment Groups at 10 Months	193500 count per microliter Interval 187600.0 to 199500.0	243300 count per microliter Interval 196600.0 to 290100.0

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Measure	Raltegravir Plus Truvada n=3 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=4 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean Platelet Count Between Treatment Groups at 12 Months	255600 count per microliter Interval 207700.0 to 318600.0	185500 count per microliter Interval 144600.0 to 216900.0

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Measure	Raltegravir Plus Truvada n=1 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=3 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean Platelet Count Between Treatment Groups at 14 Months	217400 count per microliter Interval 217400.0 to 217400.0	216800 count per microliter Interval 191400.0 to 247000.0

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Raltegravir Plus Truvada n=9 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=9 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean CD4 Count Between Treatment Groups at 1 Months	629.1 cells/mm3 Interval 345.0 to 1157.0	535 cells/mm3 Interval 370.0 to 773.0

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Measure	Raltegravir Plus Truvada n=8 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=8 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean CD4 Count Between Treatment Groups at 2 Months	703.1 cells/mm3 Interval 300.0 to 1541.0	527.2 cells/mm3 Interval 336.0 to 787.0

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Measure	Raltegravir Plus Truvada n=8 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=6 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean CD4 Count Between Treatment Groups at 3 Months	716.4 cells/mm3 Interval 399.0 to 1251.0	671.7 cells/mm3 Interval 485.0 to 903.0

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Measure	Raltegravir Plus Truvada n=5 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=2 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean CD4 Count Between Treatment Groups at 4 Months	617.2 cells/mm3 Interval 362.0 to 901.0	646.5 cells/mm3 Interval 589.0 to 704.0

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Measure	Raltegravir Plus Truvada n=6 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=5 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean CD4 Count Between Treatment Groups at 5 Months	805.7 cells/mm3 Interval 446.0 to 1991.0	539.6 cells/mm3 Interval 386.0 to 711.0

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Measure	Raltegravir Plus Truvada n=5 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=2 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean CD4 Count Between Treatment Groups at 6 Months	652.2 cells/mm3 Interval 435.0 to 986.0	673.5 cells/mm3 Interval 665.0 to 682.0

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Measure	Raltegravir Plus Truvada n=4 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=2 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean CD4 Count Between Treatment Groups at 7 Months	504 cells/mm3 Interval 300.0 to 662.0	552.5 cells/mm3 Interval 467.0 to 638.0

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Measure	Raltegravir Plus Truvada n=4 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=2 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean CD4 Count Between Treatment Groups at 8 Months	464.5 cells/mm3 Interval 365.0 to 628.0	586.5 cells/mm3 Interval 485.0 to 688.0

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Measure	Raltegravir Plus Truvada n=1 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=1 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean CD4 Count Between Treatment Groups at 9 Months	306 cells/mm3 Interval 306.0 to 306.0	571 cells/mm3 Interval 571.0 to 571.0

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Measure	Raltegravir Plus Truvada n=1 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada n=2 Participants Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean CD4 Count Between Treatment Groups at 10 Months	469 cells/mm3 Interval 469.0 to 469.0	571.5 cells/mm3 Interval 561.0 to 582.0

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Measure	Raltegravir Plus Truvada n=1 Participants Raltegravir, Truvada (tenofovir, emtricitibine): Raltegravir 400 mg. BID combined with tenofovir 300 mg and emtricitibine 200 mg once daily	Efavirenz Plus Truvada Efavirenz plus Truvada (tenofovir, emtricitibine): tenofovir with emtricitibine: efavirenz 600 mg once daily combined with tenofovir 300mg and emtricitibine 200mg once daily
Mean CD4 Count Between Treatment Groups at 11 Months	495 cells/mm3 Interval 495.0 to 495.0	—

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Principal Investigator

University of Alabama at Bimingham

Phone: 996-2371

Email: heaths@uab.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place