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
  Purpose

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.


Condition Intervention Phase
HIV Infections
Other: Sutherlandia
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 133
Study Start Date: April 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo (capsule filled with inert materials)
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
Experimental: 2
400 mg bid
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
Experimental: 3
800 mg bid
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
Experimental: 4
1200 bid
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

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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549523

Locations
South Africa
Department of Medicine, Edendale Hospital, Pvt Bag X 509
Pietermaritzburg, South Africa, 3216
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: William Folk, Ph.D. University of Missouri-Columbia School of Medicine
  More Information

Publications:
Responsible Party: William Folk, Professor of Biochemistry, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00549523     History of Changes
Other Study ID Numbers: U19 AT003264-01, U19AT003264-01, TICIPS002_RP01 (E295/05)
Study First Received: October 24, 2007
Last Updated: May 27, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board
South Africa: University of KwaZulu-Natal Institutional Review Board
South Africa: Medicines Control Council

Keywords provided by University of Missouri-Columbia:
HIV
Alternative Medicine
Complementary Medicine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 22, 2014