Treatment De-Intensification and Residual HIV-1 in Youth
NCT ID: NCT00867854
Last Updated: 2017-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
34 participants
OBSERVATIONAL
2009-02-28
2011-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Preservation and Expansion of T-cell Subsets Following HAART De-intensification to Atazanavir/Ritonavir (ATV/r)
NCT00491556
Early ART to Limit Infection and Establishment of Reservoir
NCT02859558
Analytical Treatment Interruption in HIV Positive Patients
NCT02590354
Once-daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl
NCT00532168
Strategic Timing of Antiretroviral Treatment
NCT00867048
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Blood draw
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.
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.
Blood draw
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Blood draw
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
071 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.
Exclusion Criteria
* 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.
18 Years
24 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Drug Abuse (NIDA)
NIH
National Institute of Mental Health (NIMH)
NIH
University of North Carolina, Chapel Hill
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Deborah Persaud, M.D.
Role: STUDY_CHAIR
Adolescent Trials Network
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Children's Hospital of Los Angeles
Los Angeles, California, United States
University of California at San Francisco
San Francisco, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Howard University - IMPAACT Site
Washington D.C., District of Columbia, United States
Children's Diagnostic and Teatment Center
Fort Lauderdale, Florida, United States
University of Miami School of Medicine
Miami, Florida, United States
University of South Florida College of Medicine
Tampa, Florida, United States
John Stroger Jr. Hospital of Cook County
Chicago, Illinois, United States
Children's Memorial Hospital
Chicago, Illinois, United States
Tulane Medical Center
New Orleans, Louisiana, United States
University of Maryland
Baltimore, Maryland, United States
Johns Hopkins University - IMPAACT Site
Baltimore, Maryland, United States
Mount Sinai Medical Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
University of Puerto Rico
San Juan, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
ATN website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ATN 081
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.