HIV Infections
Conditions
Keywords
Atazanavir/Ritonavir (ATV/r), highly-active antiretroviral therapy (HAART), Treatment Naive
Brief summary
This study proposes to evaluate a pre-DHHS guideline of HAART initiation and then de-intensification management strategy in adolescents with mild immunosuppression and compare changes in CD4% from baseline to week 48 and then during de-intensification.
Detailed description
This is a randomized, proof of concept study of youth 18- 24 years of age with confirmed HIV after age 9 with CD4+ T cells above 350 cells/mm3 who are randomized 3:1 to 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 two years. 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.
Interventions
PROCEDUREEarly 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.
PROCEDUREStandard 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.
Sponsors
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 yrs and 0 days to 24 yrs and 364 days; 2. CD4+ T cells \> 350/mm3 and HIV RNA ≥ 1,000 copies/ml as determined by two consecutive measures within 6 months of entry with the second measure being collected at pre-entry; 3. Infected after age 9. HIV-1 infection should be documented by any licensed ELISA test kit and confirmed by Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA at any time prior to entry; Note: Subjects who are in acute seroconversion as evidenced by being ELISA negative (antibody negative) and DNA PCR or HIV-1 RNA positive or who are ELISA positive but Western Blot indeterminate are not eligible. 4. Subjects must be naïve to ARV medications except for women who have received HAART for prevention of maternal to child transmission (MTCT) that meet the following criteria: HAART (defined as three medications from two classes) given for no more than six months for prevention of MTCT, Evidence of viral suppression on the HAART regimen defined as a plasma RNA level below the level of detection for the assay used by the site either during the third trimester or around the time of delivery, A minimum of six months since HAART exposure for prevention of MTCT, and Exposure to HAART for a single pregnancy only; Note: Prior treatment with Trizivir for prevention of MCTC is also permitted as long as viral suppression is documented at the time of delivery or in the last trimester, whichever is most recent. 5. HIV genotype without major resistance mutations to ATV/r. The following genotypic mutations exclude subjects from participation in ATN 061: Major ATV mutations I50L; I84V; N88D/S, Major PI mutations including: D30N; V32I; L33I/F/V; M46I/L; I47V/A; G48V; I50V/L; I54V/L/A/M/T/S; L76V; V82A/F/T/S/L; L90M, Any major PI mutation as defined by the most current IAS-USA Drug Resistance Mutations Figures that would adversely affect a subject's future PI choices, Major RT mutations: Q151M and 69 insertion complex; Decisions regarding the selection of an NRTI backbone for subjects with NRTI resistance mutations other than those described above will be made by the site PI in consultation with the protocol chair or his designee. Whenever possible and not otherwise contraindicated, NRTI choices should be congruent with the protocol-specified preferred regimens. The site PI must provide a copy of the genotype analysis along with their proposed regimen for review; Note: Subjects who cannot go onto either FTC/TDF or AZT/3TC must have the regimen approved by the protocol team following pre-entry screening and prior to study entry. Note: All HIV-1 genotype profiles with ANY resistance mutations must be evaluated by a physician specializing in the care of HIV-infected patients prior to final determination of subject eligibility. Polymorphism mutations should NOT be reported since their clinical significance is unknown. All other (major and minor) mutations should be appropriately categorized and reported as indicated by the case report form. In circumstances where there are numerous such mutations or other concerns present, consultation with the protocol team by the evaluating physician via the ATN QNS is highly encouraged. 6. Calculated creatinine clearance ≥60 mL/min as estimated by the Cockcroft-Gault equation: For men, (140 - age in years) x (body weight in kg) ÷ (serum creatinine in mg/dL x 72) = CrCl (mL/min)\*;\*For women, multiply the result by 0.85 = CrCl (mL/min); 7. For females with child-bearing potential, agreement to use one effective birth control method and willing to postpone pregnancy for the duration of the study (See Section 9.3 - criteria for class C drugs should be followed); and 8. Able to provide written informed consent/assent.
Exclusion criteria
1. Pregnancy; 2. On systemic immunosuppressive therapy or immune modulating therapy (short courses (\<14 days) of prednisone for reactive airway disease \[RAD\] are permitted but not within 30 days prior to study entry); 3. Any history of an AIDS-defining illness (note: a history of a CD4 + T cell count below 200 cells/mm3 is not an exclusion criterion as long as all other inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in CD4+ T Cell Percentage Between Week 0 and Week 48 | Week 0 and Week 48 |
| Difference in CD4+ T Cell Percentage Between Week 48 and Week 152 | 152 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Difference in CD8+ Naïve T-Cell Count Between Week 48 and Week 152 | 152 weeks |
| Difference in CD8+ TCM Count Between Week 0 and Week 48 | 48 weeks |
| Difference in CD8+ TCM Count Between Week 48 and Week 152 | 152 weeks |
| Difference in CD8+ TEMRo Count Between Week 0 and Week 48 | 48 weeks |
| Difference in CD8+ TEMRo Count Between Week 48 and Week 152 | 152 weeks |
| Difference in CD8+ TEMRa Count Between Week 0 and Week 48 | 48 weeks |
| Difference in CD8+ TEMRa Count Between Week 48 and Week 152 | 152 weeks |
| Difference in CD4+ Effector Memory (TEM)Ro Count Between Week 0 and Week 48 | 48 weeks |
| Difference in CD4+ TEMRo Count Between Week 48 and Week 152 | 152 weeks |
| Difference in CD4+ TEMRa Count Between Week 0 and Week 48 | 48 weeks |
| Difference in CD4+ TCM Count Between Week 48 and Week 152 | 152 weeks |
| Difference in CD4+ T Cell Count Between Week 0 and Week 48 | 48 weeks |
| Difference in CD4+ T Cell Count Between Week 48 and Week 152 | 152 weeks |
| Difference in CD4+ Naïve T Cell Count Between Week 0 and Week 48 | 48 weeks |
| Difference in CD4+ Naïve T Cell Count Between Week 48 and Week 152 | 152 weeks |
| Difference in CD4+ Termed Central Memory (TCM) Count Between Week 0 and Week 48 | 48 weeks |
| Difference in CD8 Naïve CD28 Cell Percentage Between Week 0 and Week 48 | 48 weeks |
| Difference in CD8 Naïve CD28 Cell Percentage Between Week 48 and Week 152 | 152 weeks |
| Difference in CD8 Naïve CD38 Cell Percentage Between Week 0 and Week 48 | 48 weeks |
| Difference in CD8 Naïve CD38 Cell Percentage Between Week 48 and Week 152 | 152 weeks |
| Difference in CD8 Naïve CD57 Cell Percentage Between Week 0 and Week 48 | 48 weeks |
| Difference in CD8 Naïve CD57 Cell Percentage Between Week 48 and Week 152 | 152 weeks |
| Difference in CD8 Naïve T-Cell Percentage Expressing Human Leukocyte Antigen-D Related (HLA-DR) Between Week 0 and Week 48 | 48 weeks |
| Difference in CD8 Naïve T-Cell Percentage Expressing HLA-DR Between Week 48 and Week 152 | 152 weeks |
| Difference in CD8 TCM CD28 Percentage Between Week 0 and Week 48 | 48 weeks |
| Difference in CD8 TCM CD28 Percentage Between Week 48 and Week 152 | 152 weeks |
| Difference in CD8 TCM CD38 Percentage Between Week 0 and Week 48 | 48 weeks |
| Difference in CD8 TCM CD38 Percentage Between Week 48 and Week 152 | 152 weeks |
| Difference in CD8 TCM CD57 Percentage Between Week 0 and Week 48 | 48 weeks |
| Difference in CD8 TCM CD57 Percentage Between Week 48 and Week 152 | 152 weeks |
| Difference in CD8 TCM HLA-DR Percentage Between Week 0 and Week 48 | 48 weeks |
| Difference in CD8 TCM HLA-DR Percentage Between Week 48 and Week 152 | 152 weeks |
| Difference in CD8 TEMRo CD28 Percentage Between Week 0 and Week 48 | 48 weeks |
| Difference in CD8 TEMRo CD28 Percentage Between Week 48 and Week 152 | 152 weeks |
| Difference in CD8 TEMRo CD38 Percentage Between Week 0 and Week 48 | 48 weeks |
| Difference in CD8 TEMRo CD38 Percentage Between Week 48 and Week 152 | 152 weeks |
| Difference in CD8 TEMRo CD57 Percentage Between Week 0 and Week 48 | 48 weeks |
| Difference in CD8 TEMRo CD57 Percentage Between Week 48 and Week 152 | 152 weeks |
| Difference in CD8 TEMRO HLADR Percentage Between Week 0 and Week 48 | 48 weeks |
| Difference in CD8 TEMRo HLA-DR Percentage Between Week 48 and Week 152 | 152 weeks |
| Difference in CD8 TEMRa CD28 Percentage Between Week 0 and Week 48 | 48 weeks |
| Difference in CD8 TEMRa CD28 Percentage Between Week 48 and Week 152 | 152 weeks |
| Difference in CD8 TEMRa CD38 Percentage Between Week 0 and Week 48 | 48 weeks |
| Difference in CD4+ TEMRa Count Between Week 48 and Week 152 | 152 weeks |
| Difference in CD8 TEMRa CD57 Percentage Between Week 0 and Week 48 | 48 weeks |
| Difference in CD8 TEMRa CD57 Percentage Between Week 48 and Week 152 | 152 weeks |
| Difference in CD8 TEMRa HLA-DR Percentage Between Week 0 and Week 48 | 48 weeks |
| Difference in CD8 TEMRa HLA-DR Percentage Between Week 48 and Week 152 | 152 weeks |
| Difference in CD8 TEMRa CD38 Percentage Between Week 48 and Week 152 | 152 weeks |
| Difference in CD8+ Naïve T-Cell Count Between Week 0 and Week 48 | 48 weeks |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
This research was conducted at 23 clinical sites. Accrual was open between August 2007 and June 2010.
Participants by arm
| Arm | Count |
|---|---|
| Experimental Arm 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. | 73 |
| Standard Care Arm 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. | 27 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Entry-Week (WK) 48: EXP/Standard Care | Adherence Issues | 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 | Lost to Follow-up | 1 | 0 |
| Entry-Week (WK) 48: EXP/Standard Care | Moved Out of Area | 2 | 0 |
| Entry-Week (WK) 48: EXP/Standard Care | Other | 3 | 0 |
| Entry-Week (WK) 48: EXP/Standard Care | Physician Decision | 1 | 0 |
| Entry-Week (WK) 48: EXP/Standard Care | Toxicity | 3 | 0 |
| Entry-Week (WK) 48: EXP/Standard Care | VL Failure at Week 24 | 2 | 0 |
| Entry-Week (WK) 48: EXP/Standard Care | Withdrawal by Subject | 1 | 0 |
| Wk 48-152: EXP (On De-Int)/Standard Care | Adherence Issues | 5 | 0 |
| Wk 48-152: EXP (On De-Int)/Standard Care | CD4 Failure | 2 | 0 |
| Wk 48-152: EXP (On De-Int)/Standard Care | Death of Participant | 0 | 1 |
| Wk 48-152: EXP (On De-Int)/Standard Care | End of Funding | 2 | 0 |
| Wk 48-152: EXP (On De-Int)/Standard Care | Incarceration | 0 | 1 |
| Wk 48-152: EXP (On De-Int)/Standard Care | Lost to Follow-up | 2 | 2 |
| Wk 48-152: EXP (On De-Int)/Standard Care | Moved Out of Area | 2 | 1 |
| Wk 48-152: EXP (On De-Int)/Standard Care | Other | 2 | 0 |
| Wk 48-152: EXP (On De-Int)/Standard Care | Pregnancy | 2 | 0 |
| Wk 48-152: EXP (On De-Int)/Standard Care | Toxicity | 2 | 0 |
| Wk 48-152: EXP (On De-Int)/Standard Care | VL Failure After Week 48 | 5 | 0 |
Baseline characteristics
| Characteristic | Total | Experimental Arm | Standard Care Arm |
|---|---|---|---|
| Age, Customized 18-20 years | 41 participants | 31 participants | 10 participants |
| Age, Customized 21-24 years | 59 participants | 42 participants | 17 participants |
| Race/Ethnicity, Customized Asian | 3 participants | 2 participants | 1 participants |
| Race/Ethnicity, Customized Black non-Hispanic | 70 participants | 47 participants | 23 participants |
| Race/Ethnicity, Customized Hispanic | 19 participants | 17 participants | 2 participants |
| Race/Ethnicity, Customized Other | 2 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White non-Hispanic | 6 participants | 6 participants | 0 participants |
| Region of Enrollment Puerto Rico | 1 participants | 1 participants | 0 participants |
| Region of Enrollment United States | 99 participants | 72 participants | 27 participants |
| Sex: Female, Male Female | 13 Participants | 9 Participants | 4 Participants |
| Sex: Female, Male Male | 87 Participants | 64 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 75 | 0 / 27 |
| serious Total, serious adverse events | 2 / 75 | 1 / 27 |
Outcome results
Primary
Difference in CD4+ T Cell Percentage Between Week 0 and Week 48
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD4+ T Cell Percentage Between Week 0 and Week 48 | -10.08 percentage of CD4+ T cells | Standard Deviation 5.13 |
Comparison: Null hypothesis is no changes between Baseline and Week 48.p-value: <0.000195% CI: [-12.2, -7.97]t-test, 2 sided
Primary
Difference in CD4+ T Cell Percentage Between Week 48 and Week 152
Time frame: 152 Weeks
Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD4+ T Cell Percentage Between Week 48 and Week 152 | -1.81 percentage of CD4+ T cells | Standard Deviation 5 |
Comparison: Null hypothesis is no changes between Week 48 and Week 152p-value: 0.083495% CI: [-3.87, 0.26]t-test, 2 sided
Secondary
Difference in CD4+ Effector Memory (TEM)Ro Count Between Week 0 and Week 48
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | 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 |
Comparison: Null hypothesis is no changes between Week 48 and Week 152p-value: <0.000195% CI: [-101.27, -52.57]t-test, 2 sided
Secondary
Difference in CD4+ Naïve T Cell Count Between Week 0 and Week 48
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | 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 |
Comparison: Null hypothesis is no changes between Baseline and Week 48.p-value: 0.078195% CI: [-124.77, 7.18]t-test, 2 sided
Secondary
Difference in CD4+ Naïve T Cell Count Between Week 48 and Week 152
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | 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 |
Comparison: Null hypothesis is no changes between Week 48 and Week 152p-value: 0.010295% CI: [-179.9, -27.16]t-test, 2 sided
Secondary
Difference in CD4+ T Cell Count Between Week 0 and Week 48
Time frame: 48 weeks
Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD4+ T Cell Count Between Week 0 and Week 48 | -317.36 CD4+ T cells/cubic millimeter | Standard Deviation 176.07 |
Comparison: Null hypothesis is no changes between Baseline and Week 48.p-value: <0.000195% CI: [-390.04, -244.68]t-test, 2 sided
Secondary
Difference in CD4+ T Cell Count Between Week 48 and Week 152
Time frame: 152 weeks
Population: Subjects who maintained viral load suppression from Week 24 to Week 152 among those randomized in to the experimental arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD4+ T Cell Count Between Week 48 and Week 152 | -24.20 CD4+ T cells/cubic millimeter | Standard Deviation 242.38 |
Comparison: Null hypothesis is no changes between Week 48 and Week 152p-value: 0.622295% CI: [-124.25, 75.85]t-test, 2 sided
Secondary
Difference in CD4+ TCM Count Between Week 48 and Week 152
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD4+ TCM Count Between Week 48 and Week 152 | -43.08 CD4+ TCM cells/cubic millimeter | Standard Deviation 75.17 |
Comparison: Null hypothesis is no changes between Week 48 and Week 152p-value: 0.011795% CI: [-75.59, -10.58]t-test, 2 sided
Secondary
Difference in CD4+ TEMRa Count Between Week 0 and Week 48
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD4+ TEMRa Count Between Week 0 and Week 48 | -126.79 CD4+ TEMRa cells/cubic millimeter | Standard Deviation 105.61 |
Comparison: Null hypothesis is no changes between Baseline and Week 48.p-value: <0.000195% CI: [-172.46, -81.12]t-test, 2 sided
Secondary
Difference in CD4+ TEMRa Count Between Week 48 and Week 152
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD4+ TEMRa Count Between Week 48 and Week 152 | 87.64 CD4+ TEMRa cells/cubic millimeter | Standard Deviation 97.71 |
Comparison: Null hypothesis is no changes between Week 48 and Week 152.p-value: 0.000395% CI: [45.39, 129.9]t-test, 2 sided
Secondary
Difference in CD4+ TEMRo Count Between Week 48 and Week 152
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD4+ TEMRo Count Between Week 48 and Week 152 | 16.87 CD4+ TemRo cells/cubic millimeter | Standard Deviation 68.75 |
Comparison: Null hypothesis is no changes between Week 48 and Week 152p-value: 0.251995% CI: [-12.86, 46.6]t-test, 2 sided
Secondary
Difference in CD4+ Termed Central Memory (TCM) Count Between Week 0 and Week 48
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | 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 |
Comparison: Null hypothesis is no changes between Baseline and Week 48.p-value: 0.161695% CI: [-41.66, 7.4]t-test, 2 sided
Secondary
Difference in CD8 Naïve CD28 Cell Percentage Between Week 0 and Week 48
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD8 Naïve CD28 Cell Percentage Between Week 0 and Week 48 | -18.07 percentage of CD8 naïve CD28 cells | Standard Deviation 13.2 |
Comparison: Null hypothesis is no changes between Baseline and Week 48.p-value: <0.000195% CI: [-23.78, -12.36]t-test, 2 sided
Secondary
Difference in CD8 Naïve CD28 Cell Percentage Between Week 48 and Week 152
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD8 Naïve CD28 Cell Percentage Between Week 48 and Week 152 | 1.66 percentage of CD8 Naïve CD28 Cells | Standard Deviation 14.2 |
Comparison: Null hypothesis is no changes between Week 48 and Week 152.p-value: 0.581595% CI: [-4.48, 7.8]t-test, 2 sided
Secondary
Difference in CD8 Naïve CD38 Cell Percentage Between Week 0 and Week 48
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | 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 |
Comparison: Null hypothesis is no changes between Baseline and Week 48.p-value: <0.000195% CI: [7.85, 14.62]t-test, 2 sided
Secondary
Difference in CD8 Naïve CD38 Cell Percentage Between Week 48 and Week 152
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | 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 |
Comparison: Null hypothesis is no changes between Week 48 and Week 152.p-value: 0.059495% CI: [-5.87, 0.12]t-test, 2 sided
Secondary
Difference in CD8 Naïve CD57 Cell Percentage Between Week 0 and Week 48
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | 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 |
Comparison: Null hypothesis is no changes between Baseline and Week 48.p-value: 0.000195% CI: [8.15, 17.01]t-test, 2 sided
Secondary
Difference in CD8 Naïve CD57 Cell Percentage Between Week 48 and Week 152
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | 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 |
Comparison: Null hypothesis is no changes between Week 48 and Week 152.p-value: 0.099595% CI: [-0.81, 8.66]t-test, 2 sided
Secondary
Difference in CD8+ Naïve T-Cell Count Between Week 0 and Week 48
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | 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 |
Comparison: Null hypothesis is no changes between Baseline and Week 48.p-value: 0.373995% CI: [-51.98, 132.9]t-test, 2 sided
Secondary
Difference in CD8+ Naïve T-Cell Count Between Week 48 and Week 152
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD8+ Naïve T-Cell Count Between Week 48 and Week 152 | -91.86 CD8+ naïve T cells/cubic millimeter | Standard Deviation 166.4 |
Comparison: Null hypothesis is no changes between Week 48 and Week 152.p-value: 0.014795% CI: [-163.82, -19.9]t-test, 2 sided
Secondary
Difference in CD8 Naïve T-Cell Percentage Expressing HLA-DR Between Week 48 and Week 152
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | 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 |
Comparison: Null hypothesis is no changes between Week 48 and Week 152.p-value: 0.91595% CI: [-0.61, 0.68]t-test, 2 sided
Secondary
Difference in CD8 Naïve T-Cell Percentage Expressing Human Leukocyte Antigen-D Related (HLA-DR) Between Week 0 and Week 48
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | 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 |
Comparison: Null hypothesis is no changes between Baseline and Week 48.p-value: 0.000295% CI: [1.05, 2.84]t-test, 2 sided
Secondary
Difference in CD8 TCM CD28 Percentage Between Week 0 and Week 48
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD8 TCM CD28 Percentage Between Week 0 and Week 48 | -23.52 percentage of CD8 TCM CD28 cells | Standard Deviation 13.79 |
Comparison: Null hypothesis is no changes between Baseline and Week 48.p-value: <0.000195% CI: [-29.48, -17.55]t-test, 2 sided
Secondary
Difference in CD8 TCM CD28 Percentage Between Week 48 and Week 152
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD8 TCM CD28 Percentage Between Week 48 and Week 152 | 1.95 percentage of CD8 TCM CD28 cells | Standard Deviation 16.96 |
Comparison: Null hypothesis is no changes between Week 48 and Week 152.p-value: 0.586495% CI: [-5.38, 9.28]t-test, 2 sided
Secondary
Difference in CD8 TCM CD38 Percentage Between Week 0 and Week 48
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD8 TCM CD38 Percentage Between Week 0 and Week 48 | 21.98 percentage of CD8 TCM CD38 cells | Standard Deviation 8.48 |
Comparison: Null hypothesis is no changes between Baseline and Week 48.p-value: <0.000195% CI: [18.31, 25.65]t-test, 2 sided
Secondary
Difference in CD8 TCM CD38 Percentage Between Week 48 and Week 152
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD8 TCM CD38 Percentage Between Week 48 and Week 152 | -2.20 percentage of CD8 TCM CD38 cells | Standard Deviation 7.25 |
Comparison: Null hypothesis is no changes between Week 48 and Week 152.p-value: 0.159295% CI: [-5.34, 0.93]t-test, 2 sided
Secondary
Difference in CD8 TCM CD57 Percentage Between Week 0 and Week 48
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD8 TCM CD57 Percentage Between Week 0 and Week 48 | 4.97 percentage of CD8 TCM CD57 cells | Standard Deviation 11.04 |
Comparison: Null hypothesis is no changes between Baseline and Week 48.p-value: 0.04295% CI: [0.2, 9.74]t-test, 2 sided
Secondary
Difference in CD8 TCM CD57 Percentage Between Week 48 and Week 152
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD8 TCM CD57 Percentage Between Week 48 and Week 152 | -2.20 percentage of CD8 TCM CD57 cells | Standard Deviation 12.39 |
Comparison: Null hypothesis is no changes between Week 48 and Week 152.p-value: 0.402995% CI: [-7.56, 3.16]t-test, 2 sided
Secondary
Difference in CD8+ TCM Count Between Week 0 and Week 48
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD8+ TCM Count Between Week 0 and Week 48 | 79.81 CD8+ TCM cells/cubic millimeter | Standard Deviation 76.07 |
Comparison: Null hypothesis is no changes between Baseline and Week 48.p-value: <0.000195% CI: [46.92, 112.71]t-test, 2 sided
Secondary
Difference in CD8+ TCM Count Between Week 48 and Week 152
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD8+ TCM Count Between Week 48 and Week 152 | -20.40 CD8+ TCM cells/cubic millimeter | Standard Deviation 58.18 |
Comparison: Null hypothesis is no changes between Week 48 and Week 152.p-value: 0.106795% CI: [-45.56, 4.76]t-test, 2 sided
Secondary
Difference in CD8 TCM HLA-DR Percentage Between Week 0 and Week 48
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | 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 |
Comparison: Null hypothesis is no changes between Baseline and Week 48.p-value: <0.000195% CI: [11.99, 17.21]t-test, 2 sided
Secondary
Difference in CD8 TCM HLA-DR Percentage Between Week 48 and Week 152
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | 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 6.2 |
Comparison: Null hypothesis is no changes between Week 48 and Week 152.p-value: 0.023995% CI: [-5.81, -0.46]t-test, 2 sided
Secondary
Difference in CD8 TEMRa CD28 Percentage Between Week 0 and Week 48
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD8 TEMRa CD28 Percentage Between Week 0 and Week 48 | -22.65 percentage of CD8 TemRA CD28 cells | Standard Deviation 12.93 |
Comparison: Null hypothesis is no changes between Baseline and Week 48.p-value: <0.000195% CI: [-28.24, -17.06]t-test, 2 sided
Secondary
Difference in CD8 TEMRa CD28 Percentage Between Week 48 and Week 152
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD8 TEMRa CD28 Percentage Between Week 48 and Week 152 | 4.23 percentage of CD8 TEMRa CD28 cells | Standard Deviation 15.37 |
Comparison: Null hypothesis is no changes between Week 48 and Week 152.p-value: 0.199995% CI: [-2.41, 10.88]t-test, 2 sided
Secondary
Difference in CD8 TEMRa CD38 Percentage Between Week 0 and Week 48
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD8 TEMRa CD38 Percentage Between Week 0 and Week 48 | 12.47 percentage of CD8 TEMRa CD38 cells | Standard Deviation 6.81 |
Comparison: Null hypothesis is no changes between Baseline and Week 48.p-value: <0.000195% CI: [9.52, 15.41]t-test, 2 sided
Secondary
Difference in CD8 TEMRa CD38 Percentage Between Week 48 and Week 152
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD8 TEMRa CD38 Percentage Between Week 48 and Week 152 | -1.95 percentage of CD8 TEMRa CD38 cells | Standard Deviation 5.12 |
Comparison: Null hypothesis is no changes between Week 48 and Week 152.p-value: 0.080895% CI: [-4.17, 0.26]t-test, 2 sided
Secondary
Difference in CD8 TEMRa CD57 Percentage Between Week 0 and Week 48
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD8 TEMRa CD57 Percentage Between Week 0 and Week 48 | 11.70 percentage of CD8 TEMRa CD57 cells | Standard Deviation 13.83 |
Comparison: Null hypothesis is no changes between Baseline and Week 48.p-value: 0.000595% CI: [5.72, 17.69]t-test, 2 sided
Secondary
Difference in CD8 TEMRa CD57 Percentage Between Week 48 and Week 152
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD8 TEMRa CD57 Percentage Between Week 48 and Week 152 | -0.30 percentage of CD8 TEMRa CD57cells | Standard Deviation 14.12 |
Comparison: Null hypothesis is no changes between Week 48 and Week 152.p-value: 0.919895% CI: [-6.41, 5.81]t-test, 2 sided
Secondary
Difference in CD8+ TEMRa Count Between Week 0 and Week 48
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD8+ TEMRa Count Between Week 0 and Week 48 | -39.37 CD8+ TEMRa cells/cubic millimeter | Standard Deviation 145.62 |
Comparison: Null hypothesis is no changes between Week 48 and Week 152.p-value: 0.208295% CI: [-102.34, 23.6]t-test, 2 sided
Secondary
Difference in CD8+ TEMRa Count Between Week 48 and Week 152
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD8+ TEMRa Count Between Week 48 and Week 152 | 48.27 CD8+ TEMRa cells/cubic millimeter | Standard Deviation 139.33 |
Comparison: Null hypothesis is no changes between Week 48 and Week 152.p-value: 0.006795% CI: [26.73, 147.23]t-test, 2 sided
Secondary
Difference in CD8 TEMRa HLA-DR Percentage Between Week 0 and Week 48
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | 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 |
Comparison: Null hypothesis is no changes between Baseline and Week 48.p-value: <0.000195% CI: [2.4, 4.97]t-test, 2 sided
Secondary
Difference in CD8 TEMRa HLA-DR Percentage Between Week 48 and Week 152
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | 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 |
Comparison: Null hypothesis is no changes between Week 48 and Week 152.p-value: 0.021595% CI: [-2.41, -0.21]t-test, 2 sided
Secondary
Difference in CD8 TEMRo CD28 Percentage Between Week 0 and Week 48
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD8 TEMRo CD28 Percentage Between Week 0 and Week 48 | -19.35 percentage of CD8 TEMRo CD28 cells | Standard Deviation 10.26 |
Comparison: Null hypothesis is no changes between Baseline and Week 48.p-value: <0.000195% CI: [-23.79, -14.91]t-test, 2 sided
Secondary
Difference in CD8 TEMRo CD28 Percentage Between Week 48 and Week 152
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD8 TEMRo CD28 Percentage Between Week 48 and Week 152 | -3.45 percentage of CD8 TEMRo CD28 cells | Standard Deviation 13.6 |
Comparison: Null hypothesis is no changes between Week 48 and Week 152.p-value: 0.236395% CI: [-9.33, 2.43]t-test, 2 sided
Secondary
Difference in CD8 TEMRo CD38 Percentage Between Week 0 and Week 48
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD8 TEMRo CD38 Percentage Between Week 0 and Week 48 | 19.69 percentage of CD8 TEMRo CD38 cells | Standard Deviation 8.7 |
Comparison: Null hypothesis is no changes between Baseline and Week 48.p-value: <0.000195% CI: [15.93, 23.45]t-test, 2 sided
Secondary
Difference in CD8 TEMRo CD38 Percentage Between Week 48 and Week 152
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD8 TEMRo CD38 Percentage Between Week 48 and Week 152 | -2.03 percentage of CD8 TEMRo CD38 cells | Standard Deviation 5.55 |
Comparison: Null hypothesis is no changes between Week 48 and Week 152.p-value: 0.092995% CI: [-4.43, 0.37]t-test, 2 sided
Secondary
Difference in CD8 TEMRo CD57 Percentage Between Week 0 and Week 48
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD8 TEMRo CD57 Percentage Between Week 0 and Week 48 | -2.53 percentage of CD8 TEMRo CD57 cells | Standard Deviation 8.94 |
Comparison: Null hypothesis is no changes between Baseline and Week 48.p-value: 0.188695% CI: [-6.4, 1.34]t-test, 2 sided
Secondary
Difference in CD8 TEMRo CD57 Percentage Between Week 48 and Week 152
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD8 TEMRo CD57 Percentage Between Week 48 and Week 152 | 1.87 percentage of CD8 TEMRo CD57 cells | Standard Deviation 8.13 |
Comparison: Null hypothesis is no changes between Week 48 and Week 152.p-value: 0.283195% CI: [-1.65, 5.38]t-test, 2 sided
Secondary
Difference in CD8+ TEMRo Count Between Week 0 and Week 48
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD8+ TEMRo Count Between Week 0 and Week 48 | 90.82 CD8+ TEMRo cells/cubic millimeter | Standard Deviation 107.8 |
Comparison: Null hypothesis is no changes between Baseline and Week 48.p-value: 0.000595% CI: [44.2, 137.43]t-test, 2 sided
Secondary
Difference in CD8+ TEMRo Count Between Week 48 and Week 152
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD8+ TEMRo Count Between Week 48 and Week 152 | 33.49 CD8+ TEMRo cells/cubic millimeter | Standard Deviation 64.41 |
Comparison: Null hypothesis is no changes between Week 48 and Week 152.p-value: 0.020795% CI: [5.64, 61.34]t-test, 2 sided
Secondary
Difference in CD8 TEMRO HLADR Percentage Between Week 0 and Week 48
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | Difference in CD8 TEMRO HLADR Percentage Between Week 0 and Week 48 | 11.52 percentage of CD8 TEMRO HLADR | Standard Deviation 5.59 |
Comparison: Null hypothesis is no changes between Baseline and Week 48.p-value: <0.000195% CI: [9.1, 13.94]t-test, 2 sided
Secondary
Difference in CD8 TEMRo HLA-DR Percentage Between Week 48 and Week 152
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental-Early Initiation of HAART (EXP) | 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 |
Comparison: Null hypothesis is no changes between Week 48 and Week 152.p-value: 0.015795% CI: [-5.75, -0.67]t-test, 2 sided