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Treatment De-Intensification and Residual HIV-1 in Youth | Clinical Trials | Clareo Health

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Treatment De-Intensification and Residual HIV-1 in Youth

Treatment De-Intensification and Residual HIV-1 in Adolescents and Young Adults: A Sub-Study of ATN 061 and ATN 071.

NCT00867854•University of North Carolina, Chapel Hill

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.

Eligibility

Age

18 - 24 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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;
+2 more criteria

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.
•History of an Acquired Immunodeficiency Syndrome (AIDS)-defining illness;
+1 more criteria

Locations (17)

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

Key Dates

Start Date

February 1, 2009

Primary Completion Date

October 1, 2011

Completion Date

October 1, 2011

Last Updated

February 28, 2017

Enrollment

ACTUAL participants

Conditions

HIV-1HIV Infections

Interventions

Blood draw

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 28, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Treatment De-Intensification and Residual HIV-1 in Youth

Inclusion Criteria

Exclusion Criteria

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