Stopping and Restarting Anti-HIV Drugs in Children and Adolescents With Low Blood Levels of HIV

Completed

Conditions studied: HIV Infections

In brief

Some patients taking anti-HIV drugs as part of highly active antiretroviral therapy (HAART) do not show any HIV in the blood; however, some HIV will remain hidden in the body and, if the drugs are stopped, will return to the blood. The purpose of this study is to determine if short periods of stopping HAART increase the activity of CD8 and CD4 cells (cells of the immune system that fight infection), if repeated stopping of these drugs for longer periods of time and restarting them will increase effectiveness of HAART, and if the increased immune system activity as a result of stopping treatment leads to lower levels of HIV over time.

Key facts

Study ID

NCT00016783

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

39

Expected to finish

2006-10-01

Last updated by the study team

2013-10-07

Who can join

Age: 2 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV infected
• For Cohort 1, CD4 T-cell percent greater than 20
• For Cohort 2, CD4 T-cell percent greater than 25
• Viral load less than 400 copies/ml in the year prior to study entry and less than 50 copies/ml at screening
• Taking anti-HIV drugs (including at least 1 protease inhibitor) and have been on anti-HIV drugs for at least 1 year prior to study entry
• Have been on their current drug regimen for at least 4 months
• Willing to follow study procedures
• Parental or guardian consent if under 18 years old
• Acceptable forms of contraception

You may not qualify if…

• Taking abacavir, nevirapine, efavirenz, or delavirdine
• AIDS-related or other infections needing drug treatment at study entry
• Pregnant or breastfeeding
• Have, or have had in the past, diseases (other than HIV infection) or other conditions that, in the doctor's opinion, would interfere with the study
• Taking experimental drugs without the consent of the protocol team

Where it is running

• Bronx Lebanon Hosp Ctr — The Bronx, New York, United States
• Texas Children's Hosp / Baylor Univ — Houston, Texas, United States
• San Juan City Hosp — San Juan, Puerto Rico
• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• Children's Hosp of Denver — Denver, Colorado, United States
• Howard Univ Hosp — Washington D.C., District of Columbia, United States
• Univ of Miami (Pediatric) — Miami, Florida, United States
• Chicago Children's Memorial Hosp — Chicago, Illinois, United States
• Johns Hopkins Hosp - Pediatric — Baltimore, Maryland, United States
• Children's Hosp of Boston — Boston, Massachusetts, United States
• Univ of Medicine & Dentistry of New Jersey / Univ Hosp — Newark, New Jersey, United States
• St. Lukes/Roosevelt Hosp Ctr — New York, New York, United States
• Columbia Presbyterian Med Ctr — New York, New York, United States
• Harlem Hosp Ctr — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• State Univ of New York at Stony Brook — Stony Brook, New York, United States
• SUNY Health Sciences Ctr at Syracuse / Pediatrics — Syracuse, New York, United States

Full record on ClinicalTrials.gov

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