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NCT00001097 Clinical Trial

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

HIV Infections Clinical Trial

Official title:
Establishment and Maintenance of Long-Term Undetectable Plasma HIV-1 RNA: Correlation With Immunologic Reconstitution and Viral Dynamics

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00001097
Other study ID # ACTG 381
Secondary ID PACTG 381
Status Completed
Phase N/A
First received November 2, 1999
Last updated April 23, 2010
Start date December 1997

Study information
Verified date November 2005
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 120
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 22 Years
Eligibility 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.)

Study Design

N/A

Related Conditions & MeSH terms

Locations
Country Name City State
Puerto Rico Ramon Ruiz Arnau Univ Hosp / Pediatrics Bayamon
Puerto Rico San Juan City Hosp San Juan
Puerto Rico Univ of Puerto Rico / Univ Children's Hosp AIDS San Juan
United States Emory Univ Hosp / Pediatrics Atlanta Georgia
United States Univ of Alabama at Birmingham - Pediatric Birmingham Alabama
United States Boston City Hosp / Pediatrics Boston Massachusetts
United States Children's Hosp of Boston Boston Massachusetts
United States Bronx Lebanon Hosp Ctr Bronx New York
United States Montefiore Med Ctr Adolescent AIDS Program Bronx New York
United States SUNY - Brooklyn Brooklyn New York
United States Chicago Children's Memorial Hosp Chicago Illinois
United States Cook County Hosp Chicago Illinois
United States Univ of Chicago Children's Hosp Chicago Illinois
United States Univ of Illinois College of Medicine / Pediatrics Chicago Illinois
United States Children's Med Ctr of Dallas Dallas Texas
United States Children's Hosp of Denver Denver Colorado
United States Children's Hosp of Michigan Detroit Michigan
United States Duke Univ Med Ctr Durham North Carolina
United States Connecticut Children's Med Ctr Farmington Connecticut
United States North Broward Hosp District Fort Lauderdale Florida
United States Univ of Florida Gainesville Gainesville Florida
United States North Shore Univ Hosp Great Neck New York
United States Texas Children's Hosp / Baylor Univ Houston Texas
United States Univ of Mississippi Med Ctr Jackson Mississippi
United States Univ of Florida Health Science Ctr / Pediatrics Jacksonville Florida
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 Harbor - UCLA Med Ctr / UCLA School of Medicine Los Angeles California
United States Los Angeles County - USC Med Ctr Los Angeles California
United States Saint Jude Children's Research Hosp of Memphis Memphis Tennessee
United States Univ of Miami (Pediatric) Miami Florida
United States Univ of South Alabama Mobile Alabama
United States Schneider Children's Hosp New Hyde Park New York
United States Earl K Long Early Intervention Clinic New Orleans Louisiana
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 Harlem Hosp Ctr New York New York
United States Incarnation Children's Ctr / Columbia Presbyterian Med Ctr New York New York
United States Children's Hosp of the King's Daughters Norfolk Virginia
United States Children's Hosp of Philadelphia Philadelphia Pennsylvania
United States Phoenix Childrens Hosp Phoenix Arizona
United States Palm Beach County Health Dept Riviera Beach Florida
United States Children's Hospital & Medical Center / Seattle ACTU Seattle Washington
United States Baystate Med Ctr of Springfield Springfield Massachusetts
United States SUNY Health Sciences Ctr at Syracuse / Pediatrics Syracuse New York
United States Howard Univ Hosp Washington District of Columbia

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (5)

Flynn P, Douglas S, Rudy B, Lathey J, Lindsey J, Wang Y. Establishment and maintenance of long-term undetectable plasma HIV-1 RNA: correlation with immunologic reconstitution and viral dynamics. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 692)

Flynn PM, Rudy BJ, Douglas SD, Lathey J, Spector SA, Martinez J, Silio M, Belzer M, Friedman L, D'Angelo L, McNamara J, Hodge J, Hughes MD, Lindsey JC; Pediatric AIDS Clinical Trial Group 381 Study Team. Virologic and immunologic outcomes after 24 weeks i — View Citation

Flynn PM, Rudy BJ, Lindsey JC, Douglas SD, Lathey J, Spector SA, Martinez J, Silio M, Belzer M, Friedman L, D'Angelo L, Smith E, Hodge J, Hughes MD; PACTG 381 Study Team. Long-term observation of adolescents initiating HAART therapy: three-year follow-up. — View Citation

Rudy BJ, Lindsey JC, Flynn PM, Bosch RJ, Wilson CM, Hughes ME, Douglas SD; Pediatric Aids Clinical Trials Group 381 Study Team. Immune reconstitution and predictors of virologic failure in adolescents infected through risk behaviors and initiating HAART: — View Citation

Wu H, Lathey J, Ruan P, Douglas SD, Spector SA, Lindsey J, Hughes MD, Rudy BJ, Flynn PM; PACTG 381 Team. Relationship of plasma HIV-1 RNA dynamics to baseline factors and virological responses to highly active antiretroviral therapy in adolescents (aged 1 — View Citation

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