NCT00067574

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

4 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2003

Completed
Last Updated

March 6, 2017

Status Verified

July 1, 2016

First QC Date

August 25, 2003

Last Update Submit

March 2, 2017

Conditions

HIV Infections

Keywords

Structured treatment interruptionTreatment experienced

Interventions

Structured treatment interruptionBEHAVIORAL

Eligibility Criteria

Age14 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of California at San Diego

San Diego, California, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Children's Diagnostic and Treatment Center

Fort Lauderdale, Florida, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Location

Related Links

MeSH Terms

Conditions

HIV Infections

Interventions

Treatment Interruption

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Treatment Adherence and ComplianceAttitude to HealthDelivery of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Craig M Wilson, MD

    University of Alabama at Birmingham

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2003

First Posted

August 26, 2003

Study Start

July 1, 2003

Last Updated

March 6, 2017

Record last verified: 2016-07

Locations

US(4)