Status:
COMPLETED
Treatment De-Intensification and Residual HIV-1 in Youth
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Conditions:
HIV-1
HIV Infections
Eligibility:
All Genders
18-24 years
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 f...
Eligibility Criteria
Inclusion
- 081 participants must first be enrolled in either ATN 061 or ATN 071 and meet the eligibility criteria of those protocols in addition to those below.
- 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
- 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.
- 071-Specific
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00867854
Start Date
February 1 2009
End Date
October 1 2011
Last Update
February 28 2017
Active Locations (17)
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1
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
2
University of California at San Francisco
San Francisco, California, United States, 94118
3
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
4
Howard University - IMPAACT Site
Washington D.C., District of Columbia, United States, 20060