Long-Term Effects of HAART in Youth With Stronger Immune Systems Versus Youth With Weaker Immune Systems
- Conditions
- HIV Infections
- Registration Number
- NCT00001097
- Brief Summary
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.
- Detailed Description
Recent adult clinical trials involving combination HAART, including a protease inhibitor (PI), have demonstrated improvements in somatic immune system functioning. \[AS PER AMENDMENT 2/27/01: More recently, similar success has been demonstrated with a PI-sparing regimen, zidovudine, lamivudine, and efavirenz.\] Not all individuals, however, experience the same level of immune reconstitution, and oftentimes any improvement is short-lived. Adolescent patients may have a greater potential for immune restoration because of residual thymic tissue and therefore may experience greater long-term virus-free states as compared to adult patients. This study examines the duration of virologic efficacy HAART has on the adolescent HIV-positive population.
Patients begin study by initiating a HAART regimen of a minimum of 3 drugs, at least 1 of which must be a PI \[AS PER AMENDMENT 2/27/01: or efavirenz (EFV)\]. A variety of drug combinations are used; therefore, patients are grouped according to the classes of drugs in their respective regimen (e.g., 2 nucleoside reverse transcriptase inhibitors \[NRTIs\] plus 1 PI; 2 NRTIs plus 2 PIs; 1 or 2 NRTIs plus 1 PI plus 1 nonnucleoside reverse transcriptase inhibitor \[NNRTI\] \[AS PER AMENDMENT 2/27/01: ; and 2 NRTIs plus EFV\]). At the time of HAART initiation, patients undergo immunologic and virologic assessments in order to determine baseline values. Then, to determine the virologic success or failure of HAART, HIV-1 RNA measurements are taken and compared to initial baseline values. Virologic success equals undetectable HIV-1 RNA at Week 12 \[AS PER AMENDMENT 2/27/01: and confirmed at Week 16\] or a significant (greater than 1 log) decrease in HIV-1 RNA from baseline to Week 12 \[AS PER AMENDMENT 2/27/01: and confirmed undetectable HIV-1 RNA before the next scheduled visit (Week 24)\]. Patients are followed for a minimum of 3 years of maintained viral suppression or until they have demonstrated virologic failure. From these values, any correlation that may exist between HIV-1 RNA values and HAART can be deduced. Patients with virologic failure on the initial HAART regimen may be allowed to change to a second HAART regimen. \[AS PER AMENDMENT 2/27/01: Patients with virologic success on the second HAART regimen are followed for a minimum of 3 years.\] Patients with virologic failure on the second HAART regimen or who voluntarily discontinue HAART are followed using an abbreviated schedule for 3 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (46)
Univ of Illinois College of Medicine / Pediatrics
🇺🇸Chicago, Illinois, United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
🇺🇸Los Angeles, California, United States
Connecticut Children's Med Ctr
🇺🇸Farmington, Connecticut, United States
Chicago Children's Memorial Hosp
🇺🇸Chicago, Illinois, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
🇺🇸Syracuse, New York, United States
Children's Med Ctr of Dallas
🇺🇸Dallas, Texas, United States
Children's Hosp of Boston
🇺🇸Boston, Massachusetts, United States
Boston City Hosp / Pediatrics
🇺🇸Boston, Massachusetts, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Phoenix Childrens Hosp
🇺🇸Phoenix, Arizona, United States
Children's Hosp of Denver
🇺🇸Denver, Colorado, United States
Univ of Alabama at Birmingham - Pediatric
🇺🇸Birmingham, Alabama, United States
Children's Hosp of Michigan
🇺🇸Detroit, Michigan, United States
Howard Univ Hosp
🇺🇸Washington, District of Columbia, United States
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
Univ of Florida Health Science Ctr / Pediatrics
🇺🇸Jacksonville, Florida, United States
San Juan City Hosp
🇵🇷San Juan, Puerto Rico
Saint Jude Children's Research Hosp of Memphis
🇺🇸Memphis, Tennessee, United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
🇵🇷San Juan, Puerto Rico
Ramon Ruiz Arnau Univ Hosp / Pediatrics
🇵🇷Bayamon, Puerto Rico
Children's Hosp of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Texas Children's Hosp / Baylor Univ
🇺🇸Houston, Texas, United States
Children's Hosp of the King's Daughters
🇺🇸Norfolk, Virginia, United States
Children's Hospital & Medical Center / Seattle ACTU
🇺🇸Seattle, Washington, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
🇺🇸La Jolla, California, United States
Univ of South Alabama
🇺🇸Mobile, Alabama, United States
Children's Hosp of Los Angeles/UCLA Med Ctr
🇺🇸Los Angeles, California, United States
North Broward Hosp District
🇺🇸Fort Lauderdale, Florida, United States
Univ of Florida Gainesville
🇺🇸Gainesville, 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 Mississippi Med Ctr
🇺🇸Jackson, Mississippi, United States
Univ of Chicago Children's Hosp
🇺🇸Chicago, Illinois, United States
Baystate Med Ctr of Springfield
🇺🇸Springfield, Massachusetts, United States
Earl K Long Early Intervention Clinic
🇺🇸New Orleans, Louisiana, United States
Bronx Lebanon Hosp Ctr
🇺🇸Bronx, New York, United States
North Shore Univ Hosp
🇺🇸Great Neck, New York, United States
Montefiore Med Ctr Adolescent AIDS Program
🇺🇸Bronx, New York, United States
SUNY - Brooklyn
🇺🇸Brooklyn, New York, United States
Schneider Children's Hosp
🇺🇸New Hyde Park, New York, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
Columbia Presbyterian Med Ctr
🇺🇸New York, New York, United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
🇺🇸New York, New York, United States
Harlem Hosp Ctr
🇺🇸New York, New York, United States