Treatment De-Intensification and Residual HIV-1 in Youth

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00867854
• Other study ID #: ATN 081
• Status: Completed
• Phase: N/A
• First received: March 22, 2009
• Last updated: February 27, 2017
• Start date: February 2009
• Est. completion date: October 2011

Study information

• Verified date: March 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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.

Inclusion Criteria:

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.

071-Specific Exclusion Criteria: None

Related Conditions & MeSH terms

• HIV Infections
• HIV-1

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Rico	San Juan
United States	Johns Hopkins University - IMPAACT Site	Baltimore	Maryland
United States	University of Maryland	Baltimore	Maryland
United States	Montefiore Medical Center	Bronx	New York
United States	Children's Memorial Hospital	Chicago	Illinois
United States	John Stroger Jr. Hospital of Cook County	Chicago	Illinois
United States	Children's Diagnostic and Teatment Center	Fort Lauderdale	Florida
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	University of Miami School of Medicine	Miami	Florida
United States	Tulane Medical Center	New Orleans	Louisiana
United States	Mount Sinai Medical Center	New York	New York
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of California at San Francisco	San Francisco	California
United States	University of South Florida College of Medicine	Tampa	Florida
United States	Children's National Medical Center	Washington	District of Columbia
United States	Howard University - IMPAACT Site	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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

External Links

•   ATN website