A Controlled Study of the Safety and Efficacy of Lessertia Frutescens in HIV-infected South African Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study is a 2-stage, double-blind, randomized, placebo-controlled study in which fifty-six
      HIV-positive subjects will be randomized into the first stage. Interim analysis to determine
      continuation to stage 2 will be performed to determine continuation after 8 subjects per arm
      have completed a 24-week dosing regimen.

      Primary objectives are to determine the safety of Lessertia frutescens when used by HIV-1
      infected adults with early disease, and to document the impact of Lessertia frutescens on
      markers of HIV disease progression. Secondary objective is to determine the effect of
      Lessertia frutescens on quality of life in HIV-infected adults and length of infection.
    

Detailed description: 
      The study is a 2-stage, double-blind, randomized, placebo-controlled study following a
      two-stage, statistical selection theory design. Fifty-six HIV positive subjects will be
      randomized onto Stage 1 that will comprise a 4-arm parallel group (one placebo and 3
      treatment groups) trial. One or possibly two interim analyses will be performed to determine
      continuation to Stage 2. A blinded interim analysis to determine the superior active
      treatment arm of Stage 1 will be continued to Stage 2 after 8 subjects per arm have completed
      the 24-week dosing regimen and the interim analysis. The study will be terminated if the
      interim analysis identifies either significant safety issues, or demonstrable
      non-significance. Following a significant outcome in the blinded interim analysis, the
      selected active and placebo control arms will continue blinded until total n=48 participants
      per arm for the placebo and selected treatment group have completed 24 weeks per arm.
      Respective groups will receive capsules containing L. frutescens in dosages of 0 (placebo
      material), 400mg bid, 800 mg bid or 1200 mg bid in the first stage. Progression to stage 2
      will utilize a two arm design in which 34 subjects will receive either 0 mg L. frutescens
      (placebo) or the active dosage of L. frutescens bid for 24 weeks.

      Primary objectives are to determine the safety of Lessertia frutescens when used by HIV-1
      infected adults with early disease, and to document the impact of Lessertia frutescens on
      markers of HIV disease progression. Secondary objective is to determine the effect of
      Lessertia frutescens on quality of life in HIV-infected adults and length of infection.
    

Intervention name(s): Placebo; Low Dose; Mid Dose; High Dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Capsules containing 0 mg bid (placebo); Capsules containing 400 mg bid of L. frutescens.; Capsules containing 800 mg bid of L. frutescens.; Capsules containing 1200 mg bid of L. frutescens.
Other intervention name(s): Lessertia Frutescens; Sutherlandia; Lessertia Frutescens; Sutherlandia; Lessertia Frutescens; Sutherlandia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: HIV; Alternative Medicine; Complementary Medicine