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Home > "L" Clinical Trials Conditions > Long-Term Effects of HAART in Youth with Stronger Immune Systems Versus Youth with Weaker Immune Systems  Long-Term Effects of HAART in Youth with Stronger Immune Systems Versus Youth with Weaker Immune Systems
Long-Term Effects of HAART in Youth with Stronger Immune Systems Versus Youth with Weaker Immune Systems
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Observational, Natural History, Longitudinal
Minimum Age/Maximum Age: 8 Years/22 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria 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.) Exclusion Criteria 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.)
Total Enrollment: 120
Location and Contact Information:
Overall Study Official:
PatriciaFlynn, Study Chair,
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Phoenix Childrens Hosp
Phoenix, Arizona, 85006
United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306
United States
Children's Hosp of the King's Daughters
Norfolk, Virginia, 23507
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, 900276016
United States
Children's Hosp of Michigan
Detroit, Michigan, 48201
United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, , 00956
Puerto Rico
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Schneider Children's Hosp
New Hyde Park, New York, 11040
United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Univ of Mississippi Med Ctr
Jackson, Mississippi, 39213
United States
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233
United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
Montefiore Med Ctr Adolescent AIDS Program
Bronx, New York, 10467
United States
Univ of South Alabama
Mobile, Alabama, 36604
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
SUNY - Brooklyn
Brooklyn, New York, 11203
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Palm Beach County Health Dept
Riviera Beach, Florida, 33404
United States
North Shore Univ Hosp
Great Neck, New York, 11021
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Children's Med Ctr of Dallas
Dallas, Texas, 75235
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118
United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612
United States
North Broward Hosp District
Ft. Lauderdale, Florida, 33311
United States
Earl K Long Early Intervention Clinic
New Orleans, Louisiana, 70112
United States
Univ of Florida Gainesville
Gainesville, Florida, 32610
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
United States
Connecticut Children's Med Ctr
Farmington, Connecticut, 060303805
United States
Additional Information:
Study ID Numbers: ACTG 381; PACTG 381
Study Start Date: December 1997
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001097
Other Hiv Infections Studies:
1. Study Of A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy
2. A Phase I Trial To Evaluate the Safety and Immunogenicity of the UBI HIV-1MN PND Peptide Immunogen, Given by IM Injection, in Combination With the UBI Microparticulate Monovalent HIV-1 MN Branched Peptide Given Orally, in HIV-1 Uninfected Volunteers.
3. A Multicenter Placebo-Controlled Double-Blind Trial to Evaluate Azidothymidine (AZT) Treatment of the AIDS Dementia Complex and Central Nervous System (CNS) Human Immunodeficiency Virus (HIV) Infection
4. A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months
5. Bevacizumab to Treat Kaposi's Sarcoma in HIV-Positive and HIV-Negative Patients
Related Studies:
Other HIV Infections Clinical Trials
Other Clinical Trials
Other Bayamon Clinical Trials
Long-Term Effects of HAART in Youth with Stronger Immune Systems Versus Youth with Weaker Immune Systems
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