HIV InfectionsNCT00491556
Preservation and Expansion of T-cell Subsets Following HAART De-intensification to Atazanavir/Ritonavir (ATV/r)
A study testing Early Initiation of Highly Active Anti-Retroviral Therapy in people with HIV Infections, run by University of North Carolina, Chapel Hill at 23 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Early Initiation of Highly Active Anti-Retroviral Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 23 sitesin 2 countries
- Study dates
- Oct 2007to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 yrs and 0 days to 24 yrs and 364 days;
- 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;
- 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.
- 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.
- 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.
- 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);
- 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
- Able to provide written informed consent/assent.
Who cannot join
- Pregnancy;
- 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);
- 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/exclusion criteria are met);
- Currently breast feeding;
- Current treatment for active serious systemic bacterial infections;
- Active hepatitis B infection as defined by Hepatitis B Ag positive;
Show all 12Show fewer
- Treatment with immune modulators including IL-2, intravenous gammaglobulin, and therapeutic or other experimental vaccines including HIV-1 vaccine given for primary prevention at any time;
- History of cardiac conduction abnormalities including one or more of the following: Symptomatic heart block, Third-degree heart block, even if asymptomatic, Pre-excitation syndromes, Heart Rate <40 bpm, Ventricular pause length >3 seconds, QTc > 500 msec, and Cardiomyopathy;
- Disallowed Medications (see Section 5.3.2);
- Active drug or alcohol use or dependence that, in the opinion of the site personnel, would interfere with adherence to the study;
- History of chronic renal insufficiency or Grade 3 or greater serum creatinine; and
- Any confirmed grade 3 or greater laboratory value at pre-entry (with the exception of grade 3 or greater lipids or platelets).
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States22 sites
Children's Hospital of Denver - IMPAACT Site
Aurora, Colorado, 80045
University of Maryland
Baltimore, Maryland, 21201
Johns Hopkins University - IMPAACT Site
Baltimore, Maryland, 21287
Stoger Hospital of Cook County
Chicago, Illinois, 60612
Childrens Memorial Hospital
Chicago, Illinois, 60614
Children's Hospital of Michigan - IMPAACT Site
Detroit, Michigan, 48201
Duke Pediatric Infectious Diseases - IMPAACT Site
Durham, North Carolina, 27710
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, 33316
Children's Hopsital of Los Angeles
Los Angeles, California, 90027
University of Southern California - IMPAACT Site
Los Angeles, California, 90033
St. Jude Children's Research Hospital (Memphis) - IMPAACT Site
Memphis, Tennessee, 38105
St. Jude Childrens Research Hospital
Memphis, Tennessee, 38105
University of Miami
Miami, Florida, 33101
Tulane Medical Center
New Orleans, Louisiana, 70112
Mount Sinai Medical Center
New York, New York, 10128
UMDNJ - IMPAACT Site
Newark, New Jersey, 07103
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of California at San Francisco
San Francisco, California, 94118
University of Southern Florida College of Medicine
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10467
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Howard University - IMPAACT Site
Washington D.C., District of Columbia, 20060
About this study
Official title: Preservation and Expansion of T-cell Subsets Following HAART De-intensification to Atazanavir/Ritonavir (ATV/r) in Adolescents With CD4 + T Cells > 350 Cells/mm3 Initiating HAART
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Early Initiation of Highly Active Anti-Retroviral Therapy, Standard Care
- Keywords
- Atazanavir/Ritonavir (ATV/r), highly-active antiretroviral therapy (HAART), Treatment Naive
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Initiation of Highly Active Anti-Retroviral TherapyProcedure or surgery
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 CareProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | 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. Receives: Procedure: Early Initiation of Highly Active Anti-Retroviral Therapy |
| Standard Care Arm | Other | 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. Receives: Procedure: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in CD4+ T Cell Percentage Between Week 0 and Week 48
Measured: Week 0 and Week 48
Difference in CD4+ T Cell Percentage Between Week 48 and Week 152
Measured: 152 Weeks
Secondary outcomes (50)
Difference in CD4+ T Cell Count Between Week 0 and Week 48
Measured: 48 weeks
Difference in CD4+ T Cell Count Between Week 48 and Week 152
Measured: 152 weeks
Difference in CD4+ Naïve T Cell Count Between Week 0 and Week 48
Measured: 48 weeks
Difference in CD4+ Naïve T Cell Count Between Week 48 and Week 152
Measured: 152 weeks
Difference in CD4+ Termed Central Memory (TCM) Count Between Week 0 and Week 48
Measured: 48 weeks
Difference in CD4+ TCM Count Between Week 48 and Week 152
Measured: 152 weeks
Difference in CD4+ Effector Memory (TEM)Ro Count Between Week 0 and Week 48
Measured: 48 weeks
Difference in CD4+ TEMRo Count Between Week 48 and Week 152
Measured: 152 weeks
Difference in CD4+ TEMRa Count Between Week 0 and Week 48
Measured: 48 weeks
Difference in CD4+ TEMRa Count Between Week 48 and Week 152
Measured: 152 weeks
Difference in CD8+ Naïve T-Cell Count Between Week 0 and Week 48
Measured: 48 weeks
Difference in CD8+ Naïve T-Cell Count Between Week 48 and Week 152
Measured: 152 weeks
Difference in CD8+ TCM Count Between Week 0 and Week 48
Measured: 48 weeks
Difference in CD8+ TCM Count Between Week 48 and Week 152
Measured: 152 weeks
Difference in CD8+ TEMRo Count Between Week 0 and Week 48
Measured: 48 weeks
Difference in CD8+ TEMRo Count Between Week 48 and Week 152
Measured: 152 weeks
Difference in CD8+ TEMRa Count Between Week 0 and Week 48
Measured: 48 weeks
Difference in CD8+ TEMRa Count Between Week 48 and Week 152
Measured: 152 weeks
Difference in CD8 Naïve CD28 Cell Percentage Between Week 0 and Week 48
Measured: 48 weeks
Difference in CD8 Naïve CD28 Cell Percentage Between Week 48 and Week 152
Measured: 152 weeks
Difference in CD8 Naïve CD38 Cell Percentage Between Week 0 and Week 48
Measured: 48 weeks
Difference in CD8 Naïve CD38 Cell Percentage Between Week 48 and Week 152
Measured: 152 weeks
Difference in CD8 Naïve CD57 Cell Percentage Between Week 0 and Week 48
Measured: 48 weeks
Difference in CD8 Naïve CD57 Cell Percentage Between Week 48 and Week 152
Measured: 152 weeks
Difference in CD8 Naïve T-Cell Percentage Expressing Human Leukocyte Antigen-D Related (HLA-DR) Between Week 0 and Week 48
Measured: 48 weeks
Difference in CD8 Naïve T-Cell Percentage Expressing HLA-DR Between Week 48 and Week 152
Measured: 152 weeks
Difference in CD8 TCM CD28 Percentage Between Week 0 and Week 48
Measured: 48 weeks
Difference in CD8 TCM CD28 Percentage Between Week 48 and Week 152
Measured: 152 weeks
Difference in CD8 TCM CD38 Percentage Between Week 0 and Week 48
Measured: 48 weeks
Difference in CD8 TCM CD38 Percentage Between Week 48 and Week 152
Measured: 152 weeks
Difference in CD8 TCM CD57 Percentage Between Week 0 and Week 48
Measured: 48 weeks
Difference in CD8 TCM CD57 Percentage Between Week 48 and Week 152
Measured: 152 weeks
Difference in CD8 TCM HLA-DR Percentage Between Week 0 and Week 48
Measured: 48 weeks
Difference in CD8 TCM HLA-DR Percentage Between Week 48 and Week 152
Measured: 152 weeks
Difference in CD8 TEMRo CD28 Percentage Between Week 0 and Week 48
Measured: 48 weeks
Difference in CD8 TEMRo CD28 Percentage Between Week 48 and Week 152
Measured: 152 weeks
Difference in CD8 TEMRo CD38 Percentage Between Week 0 and Week 48
Measured: 48 weeks
Difference in CD8 TEMRo CD38 Percentage Between Week 48 and Week 152
Measured: 152 weeks
Difference in CD8 TEMRo CD57 Percentage Between Week 0 and Week 48
Measured: 48 weeks
Difference in CD8 TEMRo CD57 Percentage Between Week 48 and Week 152
Measured: 152 weeks
Difference in CD8 TEMRO HLADR Percentage Between Week 0 and Week 48
Measured: 48 weeks
Difference in CD8 TEMRo HLA-DR Percentage Between Week 48 and Week 152
Measured: 152 weeks
Difference in CD8 TEMRa CD28 Percentage Between Week 0 and Week 48
Measured: 48 weeks
Difference in CD8 TEMRa CD28 Percentage Between Week 48 and Week 152
Measured: 152 weeks
Difference in CD8 TEMRa CD38 Percentage Between Week 0 and Week 48
Measured: 48 weeks
Difference in CD8 TEMRa CD38 Percentage Between Week 48 and Week 152
Measured: 152 weeks
Difference in CD8 TEMRa CD57 Percentage Between Week 0 and Week 48
Measured: 48 weeks
Difference in CD8 TEMRa CD57 Percentage Between Week 48 and Week 152
Measured: 152 weeks
Difference in CD8 TEMRa HLA-DR Percentage Between Week 0 and Week 48
Measured: 48 weeks
Difference in CD8 TEMRa HLA-DR Percentage Between Week 48 and Week 152
Measured: 152 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2007 (estimated)
- Study startOct 2007
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- Responsible party
- Sponsor
- Investigators
- Bret J Rudy, M.D., Study chair, Children's Hospital of PhiladelphiaJohn Sleasman, M.D., Study chair, University of South Florida, Dept of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00491556
- Sponsor's protocol ID
- ATN 061
- Status last verified
- May 2016
- First submitted
- 22 Jun 2007
- Last updated
- 29 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Borkar SA, Yin L, Venturi GM, Shen J, Chang KF, Fischer BM, Nepal U, Raplee ID, Sleasman JW, Goodenow MM. Youth Who Control HIV on Antiretroviral Therapy Display Unique Plasma Biomarkers and Cellular Transcriptome Profiles Including DNA Repair and RNA Processing. Cells. 2025 Feb 15;14(4):285. doi: 10.3390/cells14040285.
PubMed 39996757
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preservation and Expansion of T-cell Subsets Following HAART De-intensification to Atazanavir/Ritonavir (ATV/r) in Adolescents With CD4 + T Cells > 350 Cells/mm3 Initiating HAART
- ClinicalTrials.gov ID
- NCT00491556
- Acronym / sponsor ID
- ATN 061
- Conditions
- HIV Infections
- Keywords
- Atazanavir/Ritonavir (ATV/r), highly-active antiretroviral therapy (HAART), Treatment Naive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- Study start
- Oct 2007
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 26 Jun 2007 (estimated)
- Results
- Posted 24 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Procedure: Early Initiation of Highly Active Anti-Retroviral TherapySubjects 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. |
| Standard Care Arm | Other | Procedure: Standard CareSubjects 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 18 yrs and 0 days to 24 yrs and 364 days;
- 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;
- 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.
- 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.
- 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.
Key exclusion criteria (12 listed)
- Pregnancy;
- 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);
- 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/exclusion criteria are met);
- Currently breast feeding;
- Current treatment for active serious systemic bacterial infections;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Initiation of Highly Active Anti-Retroviral TherapyTreatment: 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. | Procedure or surgery | Experimental Arm |
| Standard CareProgression: 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. | Procedure or surgery | Standard Care Arm |
Primary outcome
Difference in CD4+ T Cell Percentage Between Week 0 and Week 48
Time frame: Week 0 and Week 48
Difference in CD4+ T Cell Percentage Between Week 48 and Week 152
Time frame: 152 Weeks
50 secondary outcomes
Difference in CD4+ T Cell Count Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD4+ T Cell Count Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD4+ Naïve T Cell Count Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD4+ Naïve T Cell Count Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD4+ Termed Central Memory (TCM) Count Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD4+ TCM Count Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD4+ Effector Memory (TEM)Ro Count Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD4+ TEMRo Count Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD4+ TEMRa Count Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD4+ TEMRa Count Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8+ Naïve T-Cell Count Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8+ Naïve T-Cell Count Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8+ TCM Count Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8+ TCM Count Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8+ TEMRo Count Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8+ TEMRo Count Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8+ TEMRa Count Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8+ TEMRa Count Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8 Naïve CD28 Cell Percentage Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8 Naïve CD28 Cell Percentage Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8 Naïve CD38 Cell Percentage Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8 Naïve CD38 Cell Percentage Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8 Naïve CD57 Cell Percentage Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8 Naïve CD57 Cell Percentage Between Week 48 and Week 152
Time frame: 152 weeks
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
Difference in CD8 Naïve T-Cell Percentage Expressing HLA-DR Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8 TCM CD28 Percentage Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8 TCM CD28 Percentage Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8 TCM CD38 Percentage Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8 TCM CD38 Percentage Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8 TCM CD57 Percentage Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8 TCM CD57 Percentage Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8 TCM HLA-DR Percentage Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8 TCM HLA-DR Percentage Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8 TEMRo CD28 Percentage Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8 TEMRo CD28 Percentage Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8 TEMRo CD38 Percentage Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8 TEMRo CD38 Percentage Between Week 48 and Week 152
Time frame: 152 weeks
Difference in CD8 TEMRo CD57 Percentage Between Week 0 and Week 48
Time frame: 48 weeks
Difference in CD8 TEMRo CD57 Percentage Between Week 48 and Week 152
Time frame: 152 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39996757Borkar SA, Yin L, Venturi GM, Shen J, Chang KF, Fischer BM, Nepal U, Raplee ID, Sleasman JW, Goodenow MM. Youth Who Control HIV on Antiretroviral Therapy Display Unique Plasma Biomarkers and Cellular Transcriptome Profiles Including DNA Repair and RNA Processing. Cells. 2025 Feb 15;14(4):285. doi: 10.3390/cells14040285.
- Description of Adolescent Trials Networks (ATN) and contact informationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bret J Rudy, M.D. study chair
Children's Hospital of Philadelphia
John Sleasman, M.D. study chair
University of South Florida, Dept of Pediatrics
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Initiation of Highly Active Anti-Retroviral Therapy in people with HIV Infections, run by University of North Carolina, Chapel Hill at 23 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in CD4+ T Cell Percentage Between Week 0 and Week 48 (time frame: Week 0 and Week 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00491556, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.