Treatment Plan to Decrease Drug Exposure in HIV Infected Adolescents
Withdrawn before enrolling · Not applicable
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00067574
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 0
- Starts
- 2003-07-01
- Last updated by the study team
- 2017-03-06
Who can join
Age: 14 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- University of California at San Diego — San Diego, California, United States
- Children's National Medical Center — Washington D.C., District of Columbia, United States
- Children's Diagnostic and Treatment Center — Fort Lauderdale, Florida, United States
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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