The Effects of Anti-HIV Therapy on the Immune Systems of Children and Young Adults Infected With HIV
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      The purpose of this study is to determine the number of newly formed CD4 cells in children
      who have taken anti-HIV drugs. The study will also evaluate the effectiveness of the new CD4
      cells in producing an immune response to hepatitis A and tetanus toxoid vaccination.

      Study hypothesis: 1) Immunologic reconstitution of individuals who have less than 15% CD4
      cells may or may not be associated with functional activity. 2) The functional immunologic
      responses to recall and newly experienced antigens may be different. 3) The functional
      responses to antigens delivered in vaccine format may be a function of CD4 level, viral load,
      or both.
    

Detailed description: 
      HIV damages the immune system by infecting CD4 cells, white blood cells that help fight
      infections and protect the body from disease. As CD4 cells die, the immune system becomes
      weak. Taking anti-HIV drugs slows the ability of the virus to multiply and kill CD4 cells.
      HIV infected children taking anti-HIV drugs have significant inhibition of HIV growth and
      significant increases in CD4 cell counts. It is not known to what extent CD4 count increases
      in HIV infected children translate to functional immune recovery. HIV infected children have
      typically demonstrated poor serological responses to routine childhood immunizations.

      Participants will either begin HAART or make a change to their current HAART regimens at
      study entry or within 2 weeks prior to study entry. All participants will have viral load
      testing when they begin or change their HAART regimens. Participants will then have a second
      viral load test after 4 weeks. Only participants with an acceptable decrease in viral load
      will continue in the study.

      Participants will be randomly assigned to one of two groups. Participants in Group 1 will
      receive tetanus toxoid immunizations (known as DTaP, DT-pediatric, or Td) at Weeks 8, 16, and
      24 and hepatitis A vaccinations at Weeks 32, 40, and 48. Participants in Group 2 will receive
      hepatitis A vaccinations at Weeks 8, 16, and 24 and tetanus toxoid immunizations at Weeks 32,
      40, and 48. Participants will have a physical exam and blood tests at study entry and at
      Weeks 4, 8, 12, 16, 24, 28, 32, 36, 40, 48, 52, 76, and 100.

      As of May 2005, participants will have the option to receive an additional hepatitis A
      vaccination booster. Those who consent and have not reached Week 100 of the study will
      receive a booster vaccination at Week 100, with a final follow-up visit occuring at Week 104.
      Those participants who do not consent will not receive the hepatitis A vaccination booster
      and will have their last follow-up visit at Week 100.
    

Intervention name(s): Tetanus toxoid; Hepatitis A Vaccine (Inactivated)
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Viral Vaccines; Drug Therapy, Combination; CD4-Positive T-Lymphocytes; Immunologic Memory; Antibody Formation; Anti-HIV Agents; Tetanus Toxoid; Hepatitis A Virus, Human; Enfuvirtide; T-20; Treatment Naive; Treatment Experienced