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Trial record 2 of 2 for:    sutherlandia

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00549523
Recruitment Status : Completed
First Posted : October 26, 2007
Last Update Posted : October 10, 2016
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Information provided by (Responsible Party):
University of Missouri-Columbia

Tracking Information
First Submitted Date  ICMJE October 24, 2007
First Posted Date  ICMJE October 26, 2007
Last Update Posted Date October 10, 2016
Study Start Date  ICMJE April 2008
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2007)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2007)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Controlled Study of the Safety and Efficacy of Lessertia Frutescens in HIV-infected South African Adults
Official Title  ICMJE 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
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 3, 2013)
133
Original Estimated Enrollment  ICMJE
 (submitted: October 25, 2007)
56
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00549523
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Missouri-Columbia
Study Sponsor  ICMJE University of Missouri-Columbia
Collaborators  ICMJE
  • National Center for Complementary and Integrative Health (NCCIH)
  • Office of Dietary Supplements (ODS)
Investigators  ICMJE
Principal Investigator: William Folk, Ph.D. University of Missouri-Columbia School of Medicine
PRS Account University of Missouri-Columbia
Verification Date October 2016

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