Treatment Plan to Decrease Drug Exposure in HIV Infected Adolescents

This study has been terminated.
Sponsor:
Collaborators:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00067574
First received: August 25, 2003
Last updated: June 23, 2005
Last verified: November 2003
  Purpose

This study will attempt to stimulate the immune system in HIV infected adolescents and young adults so that it can better control the HIV infection. When anti-HIV drugs are stopped for a period of time, the virus “grows back.” This may stimulate the immune system, which may then be more effective in controlling the virus.


Condition Intervention Phase
HIV Infections
Behavioral: Structured treatment interruption
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Structured Treatment Interruption as an Autovaccination Approach to Enhance Immune Based HIV-1 Control in an Adolescent/Young Adult Population

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment: 20
Study Start Date: July 2003
Detailed Description:

The focus of this study is to use Structured Treatment Interruption (STI) as an approach to auto-immunization. The STI management schema is based on current understanding of HIV-1 viral dynamics, pharmacology of available antiretroviral medications, and HIV-specific host responses. This is a Phase II trial to provide preliminary data on the feasibility and possible efficacy of using STI to enhance immune-based control of HIV-1 replication. A steady state HIV-1 viral load determined from historical tests prior to initiating highly active antiretroviral therapy (HAART) will be compared to the steady state viral load post-STI. HIV-1 specific CD4 and CD8 cell responses will be measured before and after the period of STI management and HIV-1 specific CD8 cell maturational phenotype will be assessed and correlated with ability to control viral replication.

Adolescents and young adults who have either had sustained viral suppression on HAART for at least 2 years or who have had sustained viral suppression from 3 to 6 months will be eligible for this study. Participants will have 12 weeks of HAART followed by 2 to 4 weeks of treatment interruption. Participants will undergo three rounds of this regimen. After the third STI, participants will have an additional 12 weeks of HAART and then stop therapy. Participants will be monitored off HAART for up to 20 weeks. During this time, if there is evidence of HIV progression (two consecutive viral loads exceeding 10,000 copies/ml; two consecutive CD4 cell counts under 350 cells/microL; two consecutive CD4 percentages less than 15%; or two consecutive CD4 cell counts less than 50% of baseline), standard continuous antiretroviral therapy will be reinstituted. Plasma HIV RNA will be tested monthly during therapy and weekly while subjects are off treatment. Immunologic studies are monthly throughout the study. Participants will be involved in the study for approximately 2 years.

  Eligibility

Ages Eligible for Study:   14 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Acquired HIV infection after age 12 years
  • CD4 cell count greater than 500 cells/microL within 30 days of study entry
  • Either on HAART for 3 to 6 months with HIV-1 RNA < 400 copies/ml or on HAART for more than 2 years with at least one HIV-1 RNA < 400 copies/ml each six month period
  • HAART regimen of two NRTIs and at least one PI (not nelfinavir)
  • HIV-1 RNA 5,000 copies/ml prior to HAART and documented CD4 cell values
  • CMV positive
  • Ability and willingness of subject (and parent/guardian where required) to give informed consent

Exclusion Criteria

  • Started initial HAART regimen less than one year after known HIV-1 seroconversion
  • Immunosuppressive therapy
  • Certain medications
  • Pregnancy
  • Evidence of an opportunistic infection
  • Laboratory values that are classified as Grade 3 or higher toxicities at the time of study enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067574

Locations
United States, California
University of California at San Diego
San Diego, California, United States
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, United States
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
Investigators
Study Chair: Craig M Wilson, MD University of Alabama at Birmingham
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00067574     History of Changes
Other Study ID Numbers: ATN 008
Study First Received: August 25, 2003
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Structured treatment interruption
Treatment experienced

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014