Treatment De-Intensification and Residual HIV-1 in Youth
Completed
Conditions studied: HIV-1, HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00867854
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 34
- Starts
- 2009-02-01
- Expected to finish
- 2011-10-01
- Last updated by the study team
- 2017-02-28
Who can join
Age: 18 and older, up to 24. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 061 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.
- 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.
- General Exclusion Criteria:
- 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.
- 061-Specific Exclusion Criteria
- History of an Acquired Immunodeficiency Syndrome (AIDS)-defining illness;
- Meets any ATN 061 exclusion criteria for de-intensification; or
- Meets any ATN 061 premature study discontinuation criteria.
Where it is running
- 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
Full record on ClinicalTrials.gov
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