This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Information provided by (Responsible Party):
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00549523
First received: October 24, 2007
Last updated: October 7, 2016
Last verified: October 2016
October 24, 2007
October 7, 2016
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 ]
Same as current
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 ]
Same as current
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider)
Primary Purpose: Supportive Care
HIV Infections
  • Drug: Placebo
    Capsules containing 0 mg bid (placebo)
  • Drug: Low Dose
    Capsules containing 400 mg bid of L. frutescens.
    Other Names:
    • Lessertia Frutescens
    • Sutherlandia
  • Drug: Mid Dose
    Capsules containing 800 mg bid of L. frutescens.
    Other Names:
    • Lessertia Frutescens
    • Sutherlandia
  • Drug: High Dose
    Capsules containing 1200 mg bid of L. frutescens.
    Other Names:
    • Lessertia Frutescens
    • Sutherlandia
  • Placebo Comparator: Placebo
    Placebo (capsule filled with inert materials)
    Intervention: Drug: Placebo
  • Experimental: Low Dose
    400 mg bid Lessertia Frutescens
    Intervention: Drug: Low Dose
  • Experimental: Mid Dose
    800 mg bid Lessertia Frutescens
    Intervention: Drug: Mid Dose
  • Experimental: High Dose
    1200 bid Lessertia Frutescens
    Intervention: Drug: High Dose

*   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.
Sexes Eligible for Study: All
21 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
South Africa
 
 
NCT00549523
U19AT003264-01( U.S. NIH Grant/Contract )
U19AT003264-01 ( U.S. NIH Grant/Contract )
TICIPS002_RP01 (E295/05) ( Other Grant/Funding Number: Office of Dietary Supplements )
Yes
Not Provided
Plan to Share IPD: No
University of Missouri-Columbia
University of Missouri-Columbia
  • National Center for Complementary and Integrative Health (NCCIH)
  • Office of Dietary Supplements (ODS)
Principal Investigator: William Folk, Ph.D. University of Missouri-Columbia School of Medicine
University of Missouri-Columbia
October 2016

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