Trial Outcomes & Findings for Preservation and Expansion of T-cell Subsets Following HAART De-intensification to Atazanavir/Ritonavir (ATV/r) (NCT NCT00491556)

NCT ID: NCT00491556

Last Updated: 2017-03-29

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 102 participants
• Primary outcome timeframe: Week 0 and Week 48
• Results posted on: 2017-03-29

Participant Flow

This research was conducted at 23 clinical sites. Accrual was open between August 2007 and June 2010.

Participant milestones

Measure	Experimental-Early Initiation of HAART (EXP) Began HAART consisting of TDF/FTC/ATV/r (preferred regimen), AZT/3TC/ATV/r, or other recommended NRTI HAART backbone with ATV/r upon entry to study. Subjects who achieved virologic control by week 24 (viral load (VL) \< 100 copies/ml) and maintained good control through 48 weeks then entered deintensification (de-int) to ATV/r alone and were followed for two years.	Standard Care (STAND) Began HAART with ATV/r under the current DHHS guidelines (CD4+ T cells below 350 cells/mm3 or for other clinical concerns as outlined in the recommendations and as determined by the site clinician).
Entry-Week (WK) 48: EXP/Standard Care STARTED	75	27
Entry-Week (WK) 48: EXP/Standard Care Wk 24 VL Suppressed (EXP)/WK 24 (STAND)	53	27
Entry-Week (WK) 48: EXP/Standard Care COMPLETED	49	27
Entry-Week (WK) 48: EXP/Standard Care NOT COMPLETED	26	0
Wk 48-152: EXP (On De-Int)/Standard Care STARTED	49	27
Wk 48-152: EXP (On De-Int)/Standard Care COMPLETED	25	22
Wk 48-152: EXP (On De-Int)/Standard Care NOT COMPLETED	24	5

Reasons for withdrawal

Measure	Experimental-Early Initiation of HAART (EXP) Began HAART consisting of TDF/FTC/ATV/r (preferred regimen), AZT/3TC/ATV/r, or other recommended NRTI HAART backbone with ATV/r upon entry to study. Subjects who achieved virologic control by week 24 (viral load (VL) \< 100 copies/ml) and maintained good control through 48 weeks then entered deintensification (de-int) to ATV/r alone and were followed for two years.	Standard Care (STAND) Began HAART with ATV/r under the current DHHS guidelines (CD4+ T cells below 350 cells/mm3 or for other clinical concerns as outlined in the recommendations and as determined by the site clinician).
Entry-Week (WK) 48: EXP/Standard Care Lost to Follow-up	1	0
Entry-Week (WK) 48: EXP/Standard Care Physician Decision	1	0
Entry-Week (WK) 48: EXP/Standard Care Withdrawal by Subject	1	0
Entry-Week (WK) 48: EXP/Standard Care Moved Out of Area	2	0
Entry-Week (WK) 48: EXP/Standard Care Failure to Suppress VL at Week 24	11	0
Entry-Week (WK) 48: EXP/Standard Care VL Failure at Week 24	2	0
Entry-Week (WK) 48: EXP/Standard Care Adherence Issues	2	0
Entry-Week (WK) 48: EXP/Standard Care Toxicity	3	0
Entry-Week (WK) 48: EXP/Standard Care Other	3	0
Wk 48-152: EXP (On De-Int)/Standard Care Lost to Follow-up	2	2
Wk 48-152: EXP (On De-Int)/Standard Care Pregnancy	2	0
Wk 48-152: EXP (On De-Int)/Standard Care Moved Out of Area	2	1
Wk 48-152: EXP (On De-Int)/Standard Care VL Failure After Week 48	5	0
Wk 48-152: EXP (On De-Int)/Standard Care CD4 Failure	2	0
Wk 48-152: EXP (On De-Int)/Standard Care Adherence Issues	5	0
Wk 48-152: EXP (On De-Int)/Standard Care Toxicity	2	0
Wk 48-152: EXP (On De-Int)/Standard Care End of Funding	2	0
Wk 48-152: EXP (On De-Int)/Standard Care Other	2	0
Wk 48-152: EXP (On De-Int)/Standard Care Incarceration	0	1
Wk 48-152: EXP (On De-Int)/Standard Care Death of Participant	0	1

Baseline Characteristics

Preservation and Expansion of T-cell Subsets Following HAART De-intensification to Atazanavir/Ritonavir (ATV/r)

Baseline characteristics by cohort

Measure	Experimental Arm n=73 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.	Standard Care Arm n=27 Participants Subjects randomized to the standard care arm will begin HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care and will be followed for a total of three years. Under these guidelines and under current clinical standards, subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur. Standard Care: Progression: Subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur. Treatment: HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care. Duration: three years.	Total n=100 Participants Total of all reporting groups
Age, Customized 18-20 years	31 participants n=5 Participants	10 participants n=7 Participants	41 participants n=5 Participants
Age, Customized 21-24 years	42 participants n=5 Participants	17 participants n=7 Participants	59 participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants	23 Participants n=7 Participants	87 Participants n=5 Participants
Race/Ethnicity, Customized White non-Hispanic	6 participants n=5 Participants	0 participants n=7 Participants	6 participants n=5 Participants
Race/Ethnicity, Customized Black non-Hispanic	47 participants n=5 Participants	23 participants n=7 Participants	70 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	17 participants n=5 Participants	2 participants n=7 Participants	19 participants n=5 Participants
Race/Ethnicity, Customized Asian	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment United States	72 participants n=5 Participants	27 participants n=7 Participants	99 participants n=5 Participants
Region of Enrollment Puerto Rico	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 0 and Week 48

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized to the experimental arm.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=25 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD4+ T Cell Percentage Between Week 0 and Week 48

-10.08 percentage of CD4+ T cells Standard Deviation 5.13

PRIMARY outcome

Timeframe: 152 Weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=25 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD4+ T Cell Percentage Between Week 48 and Week 152

-1.81 percentage of CD4+ T cells Standard Deviation 5.00

SECONDARY outcome

Timeframe: 48 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=25 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD4+ T Cell Count Between Week 0 and Week 48

-317.36 CD4+ T cells/cubic millimeter Standard Deviation 176.07

SECONDARY outcome

Timeframe: 152 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=25 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD4+ T Cell Count Between Week 48 and Week 152

-24.20 CD4+ T cells/cubic millimeter Standard Deviation 242.38

SECONDARY outcome

Timeframe: 48 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.Two subjects did not have enough blood samples to measure CD4+ Naïve T-Cell count, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD4+ Naïve T Cell Count Between Week 0 and Week 48

-58.79 CD4+ naïve t-cells/cubic millimeter Standard Deviation 152.57

SECONDARY outcome

Timeframe: 152 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.Two subjects did not have enough blood samples to measure CD4+ Naïve T-Cell count, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD4+ Naïve T Cell Count Between Week 48 and Week 152

-103.53 CD4+ naïve t-cells/cubic millimeter Standard Deviation 176.61

SECONDARY outcome

Timeframe: 48 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.Two subjects did not have enough blood samples to measure CD4+ Termed Central Memory (TCM) count, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD4+ Termed Central Memory (TCM) Count Between Week 0 and Week 48

-17.13 CD4+ TCM cells/cubic millimeter Standard Deviation 56.72

SECONDARY outcome

Timeframe: 152 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.Two subjects did not have enough blood samples to measure CD4+ TCM count, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD4+ TCM Count Between Week 48 and Week 152

-43.08 CD4+ TCM cells/cubic millimeter Standard Deviation 75.17

SECONDARY outcome

Timeframe: 48 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD4+ Effector Memory (TEM)Ro count, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD4+ Effector Memory (TEM)Ro Count Between Week 0 and Week 48

-76.92 CD4+ TemRo cells/cubic millimeter Standard Deviation 56.31

SECONDARY outcome

Timeframe: 152 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD4+ TEMRo count, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD4+ TEMRo Count Between Week 48 and Week 152

16.87 CD4+ TemRo cells/cubic millimeter Standard Deviation 68.75

SECONDARY outcome

Timeframe: 48 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD4+ TEMRa count, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD4+ TEMRa Count Between Week 0 and Week 48

-126.79 CD4+ TEMRa cells/cubic millimeter Standard Deviation 105.61

SECONDARY outcome

Timeframe: 152 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD4+ TEMRa count, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD4+ TEMRa Count Between Week 48 and Week 152

87.64 CD4+ TEMRa cells/cubic millimeter Standard Deviation 97.71

SECONDARY outcome

Timeframe: 48 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ Naïve T-Cell count, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8+ Naïve T-Cell Count Between Week 0 and Week 48

40.46 CD8+ naïve t-cells/cubic millimeter Standard Deviation 213.77

SECONDARY outcome

Timeframe: 152 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ Naïve T-Cell count, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8+ Naïve T-Cell Count Between Week 48 and Week 152

-91.86 CD8+ naïve T cells/cubic millimeter Standard Deviation 166.40

SECONDARY outcome

Timeframe: 48 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ TCM count, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8+ TCM Count Between Week 0 and Week 48

79.81 CD8+ TCM cells/cubic millimeter Standard Deviation 76.07

SECONDARY outcome

Timeframe: 152 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ TCM count, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8+ TCM Count Between Week 48 and Week 152

-20.40 CD8+ TCM cells/cubic millimeter Standard Deviation 58.18

SECONDARY outcome

Timeframe: 48 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ TEMRo count, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8+ TEMRo Count Between Week 0 and Week 48

90.82 CD8+ TEMRo cells/cubic millimeter Standard Deviation 107.80

SECONDARY outcome

Timeframe: 152 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ TEMRo count, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8+ TEMRo Count Between Week 48 and Week 152

33.49 CD8+ TEMRo cells/cubic millimeter Standard Deviation 64.41

SECONDARY outcome

Timeframe: 48 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ TEMRa count, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8+ TEMRa Count Between Week 0 and Week 48

-39.37 CD8+ TEMRa cells/cubic millimeter Standard Deviation 145.62

SECONDARY outcome

Timeframe: 152 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8+ TEMRa count, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8+ TEMRa Count Between Week 48 and Week 152

48.27 CD8+ TEMRa cells/cubic millimeter Standard Deviation 139.33

SECONDARY outcome

Timeframe: 48 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve CD28 Cell percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 Naïve CD28 Cell Percentage Between Week 0 and Week 48

-18.07 percentage of CD8 naïve CD28 cells Standard Deviation 13.20

SECONDARY outcome

Timeframe: 152 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve CD28 Cell percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 Naïve CD28 Cell Percentage Between Week 48 and Week 152

1.66 percentage of CD8 Naïve CD28 Cells Standard Deviation 14.20

SECONDARY outcome

Timeframe: 48 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve CD38 Cell percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 Naïve CD38 Cell Percentage Between Week 0 and Week 48

11.24 percentage of CD8 naïve CD38 cells Standard Deviation 7.82

SECONDARY outcome

Timeframe: 152 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve CD38 Cell percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 Naïve CD38 Cell Percentage Between Week 48 and Week 152

-2.87 percentage of CD8 naïve CD38 cells Standard Deviation 6.93

SECONDARY outcome

Timeframe: 48 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve CD57 Cell percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 Naïve CD57 Cell Percentage Between Week 0 and Week 48

12.58 percentage of CD8 naïve CD57 cells Standard Deviation 10.24

SECONDARY outcome

Timeframe: 152 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve CD57 Cell percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 Naïve CD57 Cell Percentage Between Week 48 and Week 152

3.93 percentage of CD8 naïve CD57 cells Standard Deviation 10.95

SECONDARY outcome

Timeframe: 48 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve T-Cell percentage Expressing Human Leukocyte Antigen-D related (HLA-DR), therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 Naïve T-Cell Percentage Expressing Human Leukocyte Antigen-D Related (HLA-DR) Between Week 0 and Week 48

1.95 percentage of CD8 naïve HLA-DR T-cells Standard Deviation 2.07

SECONDARY outcome

Timeframe: 152 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 Naïve T-Cell percentage Expressing HLA-D, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 Naïve T-Cell Percentage Expressing HLA-DR Between Week 48 and Week 152

0.03 percentage of CD8 naïve HLA-DR T cells Standard Deviation 1.49

SECONDARY outcome

Timeframe: 48 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM CD28 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 TCM CD28 Percentage Between Week 0 and Week 48

-23.52 percentage of CD8 TCM CD28 cells Standard Deviation 13.79

SECONDARY outcome

Timeframe: 152 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM CD28 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 TCM CD28 Percentage Between Week 48 and Week 152

1.95 percentage of CD8 TCM CD28 cells Standard Deviation 16.96

SECONDARY outcome

Timeframe: 48 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM CD38 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 TCM CD38 Percentage Between Week 0 and Week 48

21.98 percentage of CD8 TCM CD38 cells Standard Deviation 8.48

SECONDARY outcome

Timeframe: 152 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM CD38 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 TCM CD38 Percentage Between Week 48 and Week 152

-2.20 percentage of CD8 TCM CD38 cells Standard Deviation 7.25

SECONDARY outcome

Timeframe: 48 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM CD57 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 TCM CD57 Percentage Between Week 0 and Week 48

4.97 percentage of CD8 TCM CD57 cells Standard Deviation 11.04

SECONDARY outcome

Timeframe: 152 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM CD57 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 TCM CD57 Percentage Between Week 48 and Week 152

-2.20 percentage of CD8 TCM CD57 cells Standard Deviation 12.39

SECONDARY outcome

Timeframe: 48 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM HLA-DR percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 TCM HLA-DR Percentage Between Week 0 and Week 48

14.60 percentage of CD8 TCM HLA-DR T cells Standard Deviation 6.03

SECONDARY outcome

Timeframe: 152 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TCM HLA-DR percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 TCM HLA-DR Percentage Between Week 48 and Week 152

-3.14 percentage of CD8 TCM HLA-DR T cells Standard Deviation 6.20

SECONDARY outcome

Timeframe: 48 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo CD28 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 TEMRo CD28 Percentage Between Week 0 and Week 48

-19.35 percentage of CD8 TEMRo CD28 cells Standard Deviation 10.26

SECONDARY outcome

Timeframe: 152 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo CD28 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 TEMRo CD28 Percentage Between Week 48 and Week 152

-3.45 percentage of CD8 TEMRo CD28 cells Standard Deviation 13.60

SECONDARY outcome

Timeframe: 48 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo CD38 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 TEMRo CD38 Percentage Between Week 0 and Week 48

19.69 percentage of CD8 TEMRo CD38 cells Standard Deviation 8.70

SECONDARY outcome

Timeframe: 152 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo CD38 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 TEMRo CD38 Percentage Between Week 48 and Week 152

-2.03 percentage of CD8 TEMRo CD38 cells Standard Deviation 5.55

SECONDARY outcome

Timeframe: 48 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo CD57 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 TEMRo CD57 Percentage Between Week 0 and Week 48

-2.53 percentage of CD8 TEMRo CD57 cells Standard Deviation 8.94

SECONDARY outcome

Timeframe: 152 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo CD57 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 TEMRo CD57 Percentage Between Week 48 and Week 152

1.87 percentage of CD8 TEMRo CD57 cells Standard Deviation 8.13

SECONDARY outcome

Timeframe: 48 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRO HLADR percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 TEMRO HLADR Percentage Between Week 0 and Week 48

11.52 percentage of CD8 TEMRO HLADR Standard Deviation 5.59

SECONDARY outcome

Timeframe: 152 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRo HLA-DR percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 TEMRo HLA-DR Percentage Between Week 48 and Week 152

-3.21 percentage of CD8 TEMRo HLA-DR cells Standard Deviation 5.88

SECONDARY outcome

Timeframe: 48 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.Three subjects did not have enough blood samples to measure CD8 TEMRa CD28 percentage, therefore the number of participants analyzed was reduced from 25 to 22 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=22 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 TEMRa CD28 Percentage Between Week 0 and Week 48

-22.65 percentage of CD8 TemRA CD28 cells Standard Deviation 12.93

SECONDARY outcome

Timeframe: 152 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.Two subjects did not have enough blood samples to measure CD8 TEMRa CD28 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 TEMRa CD28 Percentage Between Week 48 and Week 152

4.23 percentage of CD8 TEMRa CD28 cells Standard Deviation 15.37

SECONDARY outcome

Timeframe: 48 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRa CD38 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 TEMRa CD38 Percentage Between Week 0 and Week 48

12.47 percentage of CD8 TEMRa CD38 cells Standard Deviation 6.81

SECONDARY outcome

Timeframe: 152 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRa CD38 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 TEMRa CD38 Percentage Between Week 48 and Week 152

-1.95 percentage of CD8 TEMRa CD38 cells Standard Deviation 5.12

SECONDARY outcome

Timeframe: 48 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRa CD57 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 TEMRa CD57 Percentage Between Week 0 and Week 48

11.70 percentage of CD8 TEMRa CD57 cells Standard Deviation 13.83

SECONDARY outcome

Timeframe: 152 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRa CD57 percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 TEMRa CD57 Percentage Between Week 48 and Week 152

-0.30 percentage of CD8 TEMRa CD57cells Standard Deviation 14.12

SECONDARY outcome

Timeframe: 48 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRa HLA-DR percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 TEMRa HLA-DR Percentage Between Week 0 and Week 48

3.69 percentage of CD8 TEMRa HLA-DR T cells Standard Deviation 2.97

SECONDARY outcome

Timeframe: 152 weeks

Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm. Two subjects did not have enough blood samples to measure CD8 TEMRa HLA-DR percentage, therefore the number of participants analyzed was reduced from 25 to 23 participants.

Outcome measures

Measure

Experimental-Early Initiation of HAART (EXP) n=23 Participants Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.

Difference in CD8 TEMRa HLA-DR Percentage Between Week 48 and Week 152

-1.31 percentage of CD8 TEMRa HLA-DR T cells Standard Deviation 2.54

Adverse Events

Experimental Arm

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Standard Care Arm

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Experimental Arm n=75 participants at risk Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.	Standard Care Arm n=27 participants at risk Subjects randomized to the standard care arm will begin HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care and will be followed for a total of three years. Under these guidelines and under current clinical standards, subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur. Standard Care: Progression: Subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur. Treatment: HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care. Duration: three years.
Hepatobiliary disorders Cholecystitis	1.3% 1/75 • Number of events 1 • Adverse events were collected over a 152 week period. Subjects were assessed for adverse events at each study visit.	0.00% 0/27 • Adverse events were collected over a 152 week period. Subjects were assessed for adverse events at each study visit.
Gastrointestinal disorders Pancreatitis	1.3% 1/75 • Number of events 1 • Adverse events were collected over a 152 week period. Subjects were assessed for adverse events at each study visit.	0.00% 0/27 • Adverse events were collected over a 152 week period. Subjects were assessed for adverse events at each study visit.
Investigations Neutriphil Count Decreased	1.3% 1/75 • Number of events 1 • Adverse events were collected over a 152 week period. Subjects were assessed for adverse events at each study visit.	0.00% 0/27 • Adverse events were collected over a 152 week period. Subjects were assessed for adverse events at each study visit.
Psychiatric disorders Completed Suicide	0.00% 0/75 • Adverse events were collected over a 152 week period. Subjects were assessed for adverse events at each study visit.	3.7% 1/27 • Number of events 1 • Adverse events were collected over a 152 week period. Subjects were assessed for adverse events at each study visit.

Other adverse events

Measure	Experimental Arm n=75 participants at risk Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years. Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.	Standard Care Arm n=27 participants at risk Subjects randomized to the standard care arm will begin HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care and will be followed for a total of three years. Under these guidelines and under current clinical standards, subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur. Standard Care: Progression: Subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur. Treatment: HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care. Duration: three years.
Gastrointestinal disorders Diarrhoea	6.7% 5/75 • Number of events 6 • Adverse events were collected over a 152 week period. Subjects were assessed for adverse events at each study visit.	0.00% 0/27 • Adverse events were collected over a 152 week period. Subjects were assessed for adverse events at each study visit.
Investigations Blood Bilirubin Increased	5.3% 4/75 • Number of events 6 • Adverse events were collected over a 152 week period. Subjects were assessed for adverse events at each study visit.	0.00% 0/27 • Adverse events were collected over a 152 week period. Subjects were assessed for adverse events at each study visit.

Additional Information

Dr. Bob Harris

Westat

Phone: 301-251-1500

Email: bobharris@westat.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Adolescent Medicine Trials Network (ATN) for HIV/AIDS Interventions Publication Policy outlines procedures for the development and review of abstracts, publications and presentations. The Adolescent Medicine Leadership Group (AMLG) retains custody of and primary rights to the data. Use of data must be approved by the protocol team and AMLG.
• Publication restrictions are in place

Restriction type: OTHER