Treatment De-Intensification and Residual HIV-1 in Youth
- Conditions
- HIV InfectionsHIV-1
- Interventions
- Other: Blood draw
- Registration Number
- NCT00867854
- Lead Sponsor
- University of North Carolina, Chapel Hill
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
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;
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CD4+ T cell count > 350 cells/mm3 at week 24; and
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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);
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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;
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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
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Able to provide informed consent for the sub-study and adhere to the protocol.
General
-
Currently enrolled in the Standard Care Arm of ATN 061;
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Pregnancy or breast feeding;
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Severe (Grade ≥ 3) anemia or other conditions that would not allow adequate blood volume to be drawn;
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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);
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Active hepatitis B infection as defined by Hepatitis B antigen (Ag) positive;
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Disallowed Medications (see Section 5.3.2);
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Active drug or alcohol use or dependence that, in the opinion of the site personnel, would interfere with adherence to the study; or
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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;
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Meets any ATN 061 exclusion criteria for de-intensification; or
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Meets any ATN 061 premature study discontinuation criteria.
071-Specific Exclusion Criteria: None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Experimental Blood draw 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 Blood draw 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (17)
University of California at San Francisco
🇺🇸San Francisco, California, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Howard University - IMPAACT Site
🇺🇸Washington, District of Columbia, United States
University of Miami School of Medicine
🇺🇸Miami, Florida, United States
University of South Florida College of Medicine
🇺🇸Tampa, Florida, United States
Tulane Medical Center
🇺🇸New Orleans, Louisiana, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
University of Puerto Rico
🇵🇷San Juan, Puerto Rico
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Children's Hospital of Los Angeles
🇺🇸Los Angeles, California, United States
Children's Diagnostic and Teatment Center
🇺🇸Fort Lauderdale, Florida, United States
John Stroger Jr. Hospital of Cook County
🇺🇸Chicago, Illinois, United States
Children's Memorial Hospital
🇺🇸Chicago, Illinois, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Johns Hopkins University - IMPAACT Site
🇺🇸Baltimore, Maryland, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States