Effectiveness of and Immune Response to HIV Vaccination Followed by Treatment Interruption in HIV Infected Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      HIV vaccines may help the immune systems of HIV infected patients better control the virus.
      The goal of this study is to determine whether patients on anti-HIV medications can stop
      taking those medications if they receive an HIV vaccine. While taking anti-HIV medications,
      participants will receive either an HIV vaccine or a placebo. Participants will then stop
      taking their anti-HIV medications and the study will compare the viral loads of participants
      who received the vaccine with the viral loads of participants who received the placebo.

      Primary study hypotheses: 1)The Week 12 and Week 16 post-ART interruption geometric mean
      HIV-1 RNA levels will be lower among participants who had received MRK Ad5 vaccine prior to
      ART interruption than among participants who received placebo; 2) the time averaged area
      under the curve of the log10 HIV-1 RNA copies/ml versus day function in the 16 week post-ART
      interruption step will be lower among participants who received the MRK Ad5 vaccine prior to
      ART interruption than among participants who receive placebo.
    

Detailed description: 
      Antiretroviral therapy (ART) has a significant impact on HIV disease; however, HIV cannot be
      cured with current drug regimens. While the majority of patients initially benefit from ART,
      drug regimens subsequently fail for many patients due to drug resistance, poor adherence, or
      toxicity. If given while HIV replication is kept in check by ART, an HIV vaccine may be able
      to generate an effective long-term immune response capable of controlling the virus, even if
      ART is discontinued.

      The MRK Ad5 HIV-1 gag vaccine uses a replication-defective adenovirus vector and has been
      found safe in clinical trials of both HIV infected and HIV uninfected adults. This study will
      evaluate the ability of immunization with the MRK Ad5 HIV-1 gag vaccine to control HIV
      replication in individuals undergoing treatment interruption. The study will enroll
      individuals whose HIV replication has been successfully suppressed with ART for at least 2
      years.

      Participants in this study will be randomly assigned to receive either vaccine or placebo.
      Both vaccine and placebo will be injected into the upper arm muscle. Participants will take
      their antiretroviral medications during the first 3 months of the study. Injections will be
      given on Day 1, Week 4, and Week 26. A study nurse will call participants 1 or 2 days after
      each injection and participants will be asked to fill out a card with any reactions they have
      to the injections. About 3 months after the third injection, participants will stop taking
      their antiretroviral medications for 4 months. Participants will have study visits every 2 to
      3 weeks while off medication. After 4 months, participants will have the option of restarting
      antiretroviral medications or continuing without medication. Participants will then have
      study visits every 2 months for 8 months. Study visits will include physical exams and blood
      collection.

      All participants will continue to see their primary care provider for HIV treatment and will
      be restarted on antiretroviral medications if clinically indicated. Participants or their
      primary care provider will be contacted by phone for updates every 6 months for an additional
      3.5 years.
    

Intervention name(s): MRK Ad5 HIV-1 gag vaccine; Vaccine placebo
Intervention type(s): Biological; Other
Intervention description(s): MRK Ad5 HIV-1 gag vaccine injected into the upper arm muscle.; MRK Ad5 HIV-1 gag placebo vaccine injected into the upper arm muscle.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HIV Therapeutic Vaccine; Treatment Experienced; Treatment Interruption; Adenovirus Vector