Treatment De-Intensification and Residual HIV-1 in Youth
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ClinicalTrials.gov Identifier: NCT00867854 |
Recruitment Status
:
Completed
First Posted
: March 24, 2009
Last Update Posted
: February 28, 2017
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Condition or disease | Intervention/treatment |
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HIV-1 HIV Infections | Other: Blood draw |
Study Type : | Observational |
Actual Enrollment : | 34 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Treatment De-Intensification and Residual HIV-1 in Adolescents and Young Adults: A Sub-Study of ATN 061 and ATN 071. |
Study Start Date : | February 2009 |
Actual Primary Completion Date : | October 2011 |
Actual Study Completion Date : | October 2011 |

Group/Cohort | Intervention/treatment |
---|---|
Experimental
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.
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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.
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Control
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.
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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.
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- 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 80 weeks ]
- 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. [ Time Frame: 80 weeks ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years to 24 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Twenty-five subjects enrolled in Arm A of ATN 061 who started highly-active antiretroviral therapy (HAART) at CD4+ T cells > 350 cells/cubic millimeter (mm3) and are undergoing treatment de-intensification at week 48 of HAART.
Twenty-five "control" subjects initiating HAART based on current Department of Health and Human Services (DHHS) guidelines at CD4+ T cell levels < 350 cells/mm3 and maintained on standard HAART.
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
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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);
- 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
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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;
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00867854
United States, California | |
Children's Hospital of Los Angeles | |
Los Angeles, California, United States, 90027 | |
University of California at San Francisco | |
San Francisco, California, United States, 94118 | |
United States, District of Columbia | |
Children's National Medical Center | |
Washington, District of Columbia, United States, 20010 | |
Howard University - IMPAACT Site | |
Washington, District of Columbia, United States, 20060 | |
United States, Florida | |
Children's Diagnostic and Teatment Center | |
Fort Lauderdale, Florida, United States, 33316 | |
University of Miami School of Medicine | |
Miami, Florida, United States, 33101 | |
University of South Florida College of Medicine | |
Tampa, Florida, United States, 33606 | |
United States, Illinois | |
John Stroger Jr. Hospital of Cook County | |
Chicago, Illinois, United States, 60612 | |
Children's Memorial Hospital | |
Chicago, Illinois, United States, 60614 | |
United States, Louisiana | |
Tulane Medical Center | |
New Orleans, Louisiana, United States, 70112 | |
United States, Maryland | |
University of Maryland | |
Baltimore, Maryland, United States, 21201 | |
Johns Hopkins University - IMPAACT Site | |
Baltimore, Maryland, United States, 21287 | |
United States, New York | |
Montefiore Medical Center | |
Bronx, New York, United States, 10467 | |
Mount Sinai Medical Center | |
New York, New York, United States, 10128 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Tennessee | |
St. Jude Children's Research Hospital | |
Memphis, Tennessee, United States, 38105 | |
Puerto Rico | |
University of Puerto Rico | |
San Juan, Puerto Rico, 00927 |
Study Chair: | Deborah Persaud, M.D. | Adolescent Trials Network |
Additional Information:
Responsible Party: | University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00867854 History of Changes |
Other Study ID Numbers: |
ATN 081 |
First Posted: | March 24, 2009 Key Record Dates |
Last Update Posted: | February 28, 2017 |
Last Verified: | March 2016 |
Keywords provided by University of North Carolina, Chapel Hill:
de-intensification HAART monotherapy persistent low-level viremia (LLV) treatment experienced |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |