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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001097 |
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.
Condition |
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HIV Infections |
Study Type: | Observational |
Official Title: | Establishment and Maintenance of Long-Term Undetectable Plasma HIV-1 RNA: Correlation With Immunologic Reconstitution and Viral Dynamics |
Estimated Enrollment: | 120 |
Study Start Date: | December 1997 |
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.
Ages Eligible for Study: | 8 Years to 22 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Children may be eligible for this study if they:
Exclusion Criteria
Children will not be eligible for this study if they:
Study Chair: | Patricia Flynn |
Study ID Numbers: | ACTG 381, PACTG 381 |
Study First Received: | November 2, 1999 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00001097 |
Health Authority: | United States: Federal Government |
Drug Therapy, Combination HIV Protease Inhibitors Reverse Transcriptase Inhibitors Anti-HIV Agents |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |