Long-Term Effects of HAART in Youth With Stronger Immune Systems Versus Youth With Weaker Immune Systems

Completed

Conditions studied: HIV Infections

In brief

The purpose of this study is to see if children and young adults with better immune systems before starting highly active antiretroviral therapy (HAART) do better than those who have weaker immune systems before starting HAART. HIV infection weakens the immune system's ability to fight other infections and diseases. HAART is a type of anti-HIV therapy shown to improve the immune system of adults. However, not all patients show the same amount of improvement with HAART. Doctors believe that results may depend on how strong a patient's immune system is before starting HAART. Long-term effects of HAART in children and young adults have not yet been studied.

Key facts

Study ID

NCT00001097

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

120

Starts

1997-12-01

Last updated by the study team

2010-04-26

Who can join

Age: 8 and older, up to 22. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children may be eligible for this study if they:
• Are HIV-positive.
• Are between 8 and 22 years old (consent of parent or guardian required if under 18).
• Have detectable levels of HIV in the blood within 30 days prior to study entry.
• Expect to be on the study for at least 1 year. (This study has been changed by adding this requirement.)
• Are pregnant and are not taking didanosine/stavudine (ddI/d4T) or EFV as part of their HAART regimen. (This study has been changed so that pregnant patients may be eligible if they are not taking ddI/d4T or EFV.)

You may not qualify if…

• Children will not be eligible for this study if they:
• Are taking HAART or more than 1 anti-HIV drug.
• Were infected with HIV before birth, at the time of delivery, or by a blood transfusion during birth.
• Have taken part in the study before.
• Have not responded well to HAART in the past.
• Have taken drugs to boost the immune system such as HIV vaccines, IVIG, or cytokine therapy.
• Have AIDS-related (opportunistic) infection at the time of screening. (This study has been changed so that patients with an AIDS-related infection are ineligible.)
• Are pregnant and are taking ddI/d4T or EFV as part of their HAART regimen. (This study has been changed so that pregnant patients are ineligible if they are taking ddI/d4T or EFV.)

Where it is running

• Univ of Alabama at Birmingham - Pediatric — Birmingham, Alabama, United States
• Univ of South Alabama — Mobile, Alabama, United States
• Phoenix Childrens Hosp — Phoenix, Arizona, United States
• UCSD Med Ctr / Pediatrics / Clinical Sciences — La Jolla, California, United States
• Children's Hosp of Los Angeles/UCLA Med Ctr — Los Angeles, California, United States
• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• Harbor - UCLA Med Ctr / UCLA School of Medicine — Los Angeles, California, United States
• Children's Hosp of Denver — Denver, Colorado, United States
• Connecticut Children's Med Ctr — Farmington, Connecticut, United States
• Howard Univ Hosp — Washington D.C., District of Columbia, United States
• North Broward Hosp District — Fort Lauderdale, Florida, United States
• Univ of Florida Gainesville — Gainesville, Florida, United States
• Univ of Florida Health Science Ctr / Pediatrics — Jacksonville, Florida, United States
• Univ of Miami (Pediatric) — Miami, Florida, United States
• Palm Beach County Health Dept — Riviera Beach, Florida, United States
• Emory Univ Hosp / Pediatrics — Atlanta, Georgia, United States
• Cook County Hosp — Chicago, Illinois, United States
• Univ of Illinois College of Medicine / Pediatrics — Chicago, Illinois, United States
• Chicago Children's Memorial Hosp — Chicago, Illinois, United States
• Univ of Chicago Children's Hosp — Chicago, Illinois, United States
• Earl K Long Early Intervention Clinic — New Orleans, Louisiana, United States
• Children's Hosp of Boston — Boston, Massachusetts, United States
• Boston City Hosp / Pediatrics — Boston, Massachusetts, United States
• Baystate Med Ctr of Springfield — Springfield, Massachusetts, United States
• Children's Hosp of Michigan — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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