A Controlled Study of the Safety and Efficacy of Lessertia Frutescens in HIV-infected South African Adults

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
William Folk, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00549523
First received: October 24, 2007
Last updated: May 27, 2014
Last verified: May 2014

October 24, 2007
May 27, 2014
April 2008
January 2012   (final data collection date for primary outcome measure)
Primary: determine safety of L. frutescens when used by HIV-1 infected adults with early disease, and to document disease progression. [ Time Frame: 24 week treatment period ] [ Designated as safety issue: Yes ]
Primary: determine safety of L. frutescens when used by HIV-1 infected adults with early disease, and to document disease progression. [ Time Frame: 24 week treatment period ]
Complete list of historical versions of study NCT00549523 on ClinicalTrials.gov Archive Site
Secondary: Determine the effect of L. frutescens on quality of life in HIV-1 infected adults, and length of infection. [ Time Frame: 24 week treatment period ] [ Designated as safety issue: Yes ]
Secondary: Determine the effect of L. frutescens on quality of life in HIV-1 infected adults, and length of infection. [ Time Frame: 24 week treatment period ]
Not Provided
Not Provided
 
A Controlled Study of the Safety and Efficacy of Lessertia Frutescens in HIV-infected South African Adults
A Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy of Lessertia Frutescens (L.)Goldblatt and J.C. Manning (Syn. Sutherlandia Frutescens (L.)R. Br.)in HIV-infected South African Adults

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
HIV Infections
Other: Sutherlandia
Capsules containing 0 mg bid (placebo), 400 mg bid, 800 mg bid, or 1200 mg bid of L. frutescens.
Other Names:
  • Lessertia
  • Sutherlandia
  • Placebo Comparator: 1
    Placebo (capsule filled with inert materials)
    Intervention: Other: Sutherlandia
  • Experimental: 2
    400 mg bid
    Intervention: Other: Sutherlandia
  • Experimental: 3
    800 mg bid
    Intervention: Other: Sutherlandia
  • Experimental: 4
    1200 bid
    Intervention: Other: Sutherlandia
Johnson Q, Syce J, Nell H, Rudeen K, Folk WR. A randomized, double-blind, placebo-controlled trial of Lessertia frutescens in healthy adults. PLoS Clin Trials. 2007 Apr 27;2(4):e16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
133
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 21 - 65 years
  • HIV-1 infection documented by two different rapid tests for HIV-1 antibodies
  • CD4 count >350 cells/ul
  • Viral load< 20,000 copies/mL
  • Normal hematological function
  • Absence of clinically significant renal disease
  • Normal liver function
  • Random glucose < 11.1 mmol/L
  • Normal electrocardiogram
  • Regular attendance at the Wellness Clinic for at least 4 visits
  • Cognitive capacity sufficient to provide informed consent

Exclusion Criteria:

  • Any AIDS-defining diagnosis
  • Weight loss > 5% of body weight within the preceding six months
  • Other features of undiagnosed tuberculosis (including cough, fatigue, drenching night sweats and abnormal chest radiograph)
  • Any other significant disease (active TB, hypertension, diabetes mellitus and other endocrine disorders, peptic ulcer disease, gastrointestinal malabsorption, psychiatric illness) either newly diagnosed or controlled by medication.
  • Use of any allopathic or traditional medicine other than isoniazid for TB prophylaxis.
  • Prior or current use of antiretroviral therapy
  • History of allergic conditions or drug allergy/hypersensitivity
  • Either history or family history of autoimmune disease
  • Alcohol use of >7 units per week or >3 per session, tobacco use of more than 10 cigarettes per day or description of recreational drug use within the past 6 months.
Both
21 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT00549523
U19 AT003264-01, U19AT003264-01, TICIPS002_RP01 (E295/05)
Yes
William Folk, University of Missouri-Columbia
University of Missouri-Columbia
  • National Center for Complementary and Alternative Medicine (NCCAM)
  • Office of Dietary Supplements (ODS)
Principal Investigator: William Folk, Ph.D. University of Missouri-Columbia School of Medicine
University of Missouri-Columbia
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP