Treatment De-Intensification and Residual HIV-1 in Youth
1 other identifier
observational
34
2 countries
17
Brief Summary
This laboratory-based sub-study of ATN 061 and ATN 071 will examine the effect of early treatment followed by treatment de-intensification to atazanavir/ritonavir (ATV/r) monotherapy on steady-state frequencies of replication-competent CD4+ T cell Human Immunodeficiency Virus (HIV)-1 reservoirs or cell-associated infectivity (CAI) and persistent low-level viremia (LLV), and their contribution to successful long-term control of HIV-1 replication among HIV-1 infected adolescents and young adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2009
Typical duration for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 22, 2009
CompletedFirst Posted
Study publicly available on registry
March 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedFebruary 28, 2017
March 1, 2016
2.7 years
March 22, 2009
February 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Steady-state frequencies of replication-competent CD4+ T cell HIV-1 reservoirs in participants starting HAART before DHHS guidelines (CD4+ T cell levels < 350 cells/mm3) vs. those initiating HAART by current DHHS guidelines.
80 weeks
Quantitative changes in LLV between 6.5 and 50 copies/ml in participants starting early therapy & de-intensifying to ATV/r monotherapy vs. those initiating HAART at CD4+ T cell levels < 350 cells/mm3 & maintaining standard HAART.
80 weeks
Quantitative changes in viral diversity during HAART in participants initiating early therapy & de-intensifying to ATV/r monotherapy vs those initiating HAART at CD4+ T cell levels < 350 cells/mm3 & maintaining standard HAART.
80 weeks
Effect of viral diversity in replication-competent CD4+ T cell reservoirs & low viremia variants before de-intensification on successful control of HIV-1 replication during ATV/r maintenance in participants starting HAART before DHHS guidelines.
80 weeks
Secondary Outcomes (1)
To examine the contribution of LLV genotypes, through analysis of the Gag/protease and RT, among subjects who developed rebound viremia above 50 copies/ml during treatment de-intensification to ATV/r.
80 weeks
Study Arms (2)
Experimental
25 evaluable subjects from the experimental arm of ATN 061 who undergo de-intensification to boosted atazanavir (ATV) with VL suppression of \< 100 copies/ml and CD4+ T cells \> 350 cells/mm3 at week 48 and maintain VL suppression to \< 400 copies/ml with stable CD4+ T cell counts after week 48.
Control
25 evaluable subjects from ATN 071 will also be enrolled. These subjects will have initiated HAART according to current DHHS guidelines (CD4+ T cells \< 350 cells/mm3), had viral load suppression to \< 100 copies/ml at 24 through 48 weeks on HAART and maintained suppression to \< 400 copies/ml through week 80.
Interventions
This sub-study does not involve additional treatment of any ATN 061 or ATN 071 study subjects. The only intervention involved is the requirement for whole blood collection (40 ml and 60 ml) to be drawn at the same time as four ATN 061 study visits (36, 48, 56, and 80 weeks) for subjects co-enrolled into ATN 061. When these time points coincide with ATN 061 Central Laboratory samples, the 60 ml blood sample will not be collected. For subjects co-enrolled into ATN 071, there are also two samples of whole blood collection (40 ml and 60 ml) required to be drawn at four time points but at weeks 36, 48, 56, and 80 after the initiation of HAART.
Eligibility Criteria
Twenty-five subjects enrolled in Arm A of ATN 061 who started highly-active antiretroviral therapy (HAART) at CD4+ T cells \> 350 cells/cubic millimeter (mm3) and are undergoing treatment de-intensification at week 48 of HAART. Twenty-five "control" subjects initiating HAART based on current Department of Health and Human Services (DHHS) guidelines at CD4+ T cell levels \< 350 cells/mm3 and maintained on standard HAART.
You may qualify if:
- Participants
- Currently on treatment with an ATV/r-based HAART regimen (ATV/r, FTC, TDF is the preferred regimen);
- HIV-1 viral load \< 100 copies at week 24;
- CD4+ T cell count \> 350 cells/mm3 at week 24; and
- Able to provide informed consent for the sub-study and adhere to the protocol.
- Participants
- Initiated HAART according to current DHHS guidelines (CD4+ T cells \< 350 cells/ mm3);
- Currently on treatment with a PI-containing HAART regimen; subjects taking a protease inhibitor OTHER than ATV/r must receive approval by the team via the ATN QNS;
- Plasma HIV-1 viral load \< 100 copies at week 24 on HAART; measurement to be collected from clinical care results contained in the medical record at the clinical site within +/- 30 days of week 24 on therapy;
- CD4+ T cell count \> 350 cells/mm3 at week 24 on HAART; measurement to be collected from clinical care results contained in the medical record at the clinical site within +/- 30 days of week 24 on therapy; and
- Able to provide informed consent for the sub-study and adhere to the protocol.
You may not qualify if:
- Currently enrolled in the Standard Care Arm of ATN 061;
- Pregnancy or breast feeding;
- Severe (Grade ≥ 3) anemia or other conditions that would not allow adequate blood volume to be drawn;
- Active treatment for systemic infections;
- Treatment with immune modulators, including immunosuppressive or immune modulating therapy (IL-2, intravenous gammaglobulin, and therapeutic or other experimental vaccines including HIV-1 vaccine given for primary prevention at any time (short courses (\<14 days) of prednisone for reactive airway disease (RAD) are permitted);
- Active hepatitis B infection as defined by Hepatitis B antigen (Ag) positive;
- 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; or
- History of chronic renal insufficiency or Grade 3 or greater serum creatinine.
- History of an Acquired Immunodeficiency Syndrome (AIDS)-defining illness;
- Meets any ATN 061 premature study discontinuation criteria.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
University of California at San Francisco
San Francisco, California, 94118, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Howard University - IMPAACT Site
Washington D.C., District of Columbia, 20060, United States
Children's Diagnostic and Teatment Center
Fort Lauderdale, Florida, 33316, United States
University of Miami School of Medicine
Miami, Florida, 33101, United States
University of South Florida College of Medicine
Tampa, Florida, 33606, United States
John Stroger Jr. Hospital of Cook County
Chicago, Illinois, 60612, United States
Children's Memorial Hospital
Chicago, Illinois, 60614, United States
Tulane Medical Center
New Orleans, Louisiana, 70112, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Johns Hopkins University - IMPAACT Site
Baltimore, Maryland, 21287, United States
Mount Sinai Medical Center
New York, New York, 10128, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
University of Puerto Rico
San Juan, 00927, Puerto Rico
Related Links
Biospecimen
Whole blood
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Deborah Persaud, M.D.
Adolescent Trials Network
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2009
First Posted
March 24, 2009
Study Start
February 1, 2009
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
February 28, 2017
Record last verified: 2016-03