Study Comparing Racivir and Lamivudine in Treatment-Experienced HIV Subjects
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Racivir ® (RCV) is an experimental drug which means it is not approved for use by the United
      States Food and Drug Administration (FDA), but it can be used in research studies like this
      one. RCV (Racivir®) is part of a class of drugs known as "Nucleoside Reverse Transcriptase
      Inhibitors" (NRTIs), which are intended to block a further increase in the amount of HIV
      virus in the body. Laboratory research suggests that RCV (Racivir®) may be effective in
      patients who have developed resistance to other NRTIs, particularly 3TC (lamivudine,
      Epivir®). However, a study of RCV (Racivir®) has not been done with patients who have
      previously been treated with other HAART (Highly Active Antiretroviral Therapy -- taking
      multiple HIV drugs at once) medications including 3TC (lamivudine, Epivir®).

      The purpose of this study is to evaluate the safety and effectiveness of RCV (Racivir®) when
      used together with other HIV drugs in people who have previously been treated with 3TC
      (lamivudine, Epivir®) and are failing with their current HAART treatments. This study will
      include a total of 60 HIV infected, HAART-experienced subjects currently receiving 3TC
      (lamivudine, Epivir®) as part of their HAART therapy. The study will take place at
      approximately 11 study sites in the US and Latin America.
    

Detailed description: 
      The study is divided into four periods: a 'Screening' period which can last up to 30 days in
      duration, a 'Blinded Treatment' period which can last up to 4 weeks in duration, a
      'Follow-up' period which is 28 days in duration, and an 'Open-label Treatment' period that
      some subjects will be given the option to participate in and which can last up to 20 weeks.

      If eligible subjects decide to participate in this research study, they will be randomized,
      which is like picking chances from a hat, to get RCV (Racivir®) alone, 3TC (lamivudine,
      Epivir®) alone, or RCV and 3TC (lamivudine, Epivir®) in combination. This is a "double-blind
      study". This means that neither the subject nor the study doctor and study staff will know if
      subjects are receiving RCV (Racivir®), 3TC (lamivudine, Epivir®), or RCV (Racivir®) and 3TC
      (lamivudine, Epivir®). This needs to be done to make sure the researchers obtain the
      information needed to see if RCV (Racivir®) is safe and as effective as 3TC (lamivudine,
      Epivir®). In case of an emergency, the study doctor will be able to find out immediately what
      study drug subjects were receiving. With this exception, by signing the consent form subjects
      agree that they will not be able to find out what medications they are taking, because this
      is a "double-blind" study, it is necessary to use placebo tablets. A placebo is a tablet that
      does not contain any active drug, but is made to look just like the study drug.

      Subjects will be given three bottles of study medication. They will be asked to take one
      tablet from each bottle once a day by mouth, in addition to their current HAART drugs, not
      including 3TC. The 3TC in their current HAART regimen must be discontinued prior to beginning
      the study medication. It is important that subjects follow all directions when taking the
      study drugs.

      After completing the first 14 days of the blinded treatment period, subjects will be given
      the option to continue on their current randomized therapy, including their current study
      medication, for an additional 1-2 weeks. On Day 15, a blood sample will be collected to
      determine the amount of HIV virus in the blood. Once the results from that blood sample are
      available, subjects will be told the amount of how much HIV virus changed in the blood during
      the first 14 days of treatment. Subjects will also be told if they were receiving RCV
      (Racivir®) alone, 3TC (lamivudine, Epivir®) alone, or a combination of RCV (Racivir®) and 3TC
      (lamivudine, Epivir®).

      If subjects were receiving RCV (Racivir®), to continue in the open-label treatment period,
      the amount of virus in the blood must drop by at least 2/3 during the first 14 days of the
      blinded treatment period. For example, if subjects enter the study with 10,000 copies of the
      HIV virus per milliliter (ml) of blood, then to continue in the open-label period, the virus
      level must drop to 3,162 copies or less, per ml of blood. Open-label means that participating
      subjects and the study doctor or study staff will know what treatment subjects were
      receiving.

      If the virus drops by at least 2/3, subjects will be given the option to enter an open-label
      treatment period. During the open-label period, subjects will receive 600 mg RCV (Racivir®)
      once daily along with their regular HAART medications. Before entering the open-label period,
      the study doctor may decide to change the subject's other ARV medications. Participating
      subjects will be financially responsible for all medications, other than RCV (Racivir®), that
      the study doctor may prescribe.

      Once treatment is "unblinded", subjects may learn that they were not receiving any RCV
      (Racivir®) during the blinded treatment period. Subjects may voluntarily decide to add 600 mg
      RCV (Racivir®) once daily to the other HAART medications. The study doctor may decide to
      change the subject's HAART medications at this time. After 2 weeks of RCV (Racivir®) based
      treatment, subjects will be asked to return to the study doctor's office to have blood drawn
      to determine the amount of HIV virus in the blood. Subjects may continue on RCV (Racivir®)
      for up to an additional 2 weeks until the results from the blood test are available. If the
      viral load does not decline by at least 2/3, subjects will be withdrawn from the open-label
      portion of the study. Subjects will be asked to return to the study doctor's office for a
      final follow-up visit approximately 28 days after the last dose of RCV (Racivir®).

      The open-label treatment period will last no longer than 20 weeks. During this study,
      subjects can receive up to 24 weeks of RCV (Racivir®) therapy. After subjects receive the
      last dose of study medication, they will enter the follow-up period for 28 days.

      If a participating subject or the study doctor decides to withdraw from the study early,
      subjects will need to return to the study doctor's office to have a follow-up visit
      approximately 28 days after the last dose of RCV (Racivir®).
    

Intervention name(s): Racivir, a non-nucleoside reverse transcriptase inhibitor
Intervention type(s): Drug
Intervention MeSH terms: Reverse Transcriptase Inhibitors; Racivir
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Keywords: HIV; treatment-experienced; lamivudine; 3TC