Long-Term Effects of HAART in Youth With Stronger Immune Systems Versus Youth With Weaker Immune Systems
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Observational

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.
    

Keywords: Drug Therapy, Combination; HIV Protease Inhibitors; Reverse Transcriptase Inhibitors; Anti-HIV Agents