Effectiveness of Antiretroviral Therapy During Acute HIV Infection
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine whether HIV treatment that is initiated during the acute phase of
      HIV infection, followed by discontinuation of treatment, is effective in reducing the amount
      of HIV and an increasing the amount of CD4 cells in the blood of people with HIV, compared to
      the amounts of HIV and CD4 cells in people who do not receive treatment at this stage.
    

Detailed description: 
      Antiretroviral (ARV) therapy for the treatment of HIV infection has been remarkably
      successful in reducing morbidity and mortality in HIV infected people. This treatment still
      has its shortcomings, however. Individuals receiving ARV treatment are at risk of toxicity,
      developing drug resistance, and unknown long-term side effects. Therefore, development of
      alternative treatment strategies is important. A short course of ARV treatment that is
      initiated during the acute period of HIV infection, followed by treatment cessation may have
      a substantial impact on controlling infection and delaying the need for lifelong potent ARV
      therapy. The purpose of this study is to investigate whether treatment initiated during acute
      HIV infection and followed by a terminal treatment interruption is effective in lowering the
      viral load set point and raising CD4 cell counts in people with HIV, as compared to those
      measures in people with HIV who have received no treatment.

      Participants in this study will be randomly assigned to one of three groups. Participants in
      Group A1 will receive ARV therapy for 12 weeks. Participants in Group A2 will receive ARV
      therapy for 32 weeks. Participants in Group B will not receive any treatment. This study will
      not provide medications to any of the groups. All groups will be followed for a total of 72
      weeks following study entry. Participants will attend between 30 and 36 study visits over the
      course of the 72 weeks, depending on their study group. Study visits will occur every week
      for the first 12 weeks and then every 1 to 6 weeks for the remainder of the study. Tests
      occurring at study visits may include blood tests, investigational immune system tests, and
      pregnancy tests. Participants will also undergo a complete physical exam and will be asked to
      provide information about their medical and medication histories.
    

Intervention name(s): Highly Active Antiretroviral Therapy (HAART); No treatment
Intervention type(s): Drug; Other
Intervention description(s): Participants in Groups A1 and A2 will receive HAART for either 12 or 32 weeks. Their medications will not be provided by the study.; Participants in this group will not receive treatment at this stage of their infection.
Intervention MeSH terms: Anti-Retroviral Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Infection; HIV; HAART; Treatment Naive