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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00549523
• Other study ID #: U19AT003264-01
• Secondary ID: U19AT003264-01TI
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 24, 2007
• Last updated: October 7, 2016
• Start date: April 2008
• Est. completion date: January 2012

Study information

• Verified date: October 2016
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review BoardSouth Africa: Human Research Ethics CommitteeSouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Placebo
Capsules containing 0 mg bid (placebo)
• Low Dose
Capsules containing 400 mg bid of L. frutescens.
• Mid Dose
Capsules containing 800 mg bid of L. frutescens.
• High Dose
Capsules containing 1200 mg bid of L. frutescens.

Locations

Country	Name	City	State
South Africa	Department of Medicine, Edendale Hospital, Pvt Bag X 509	Pietermaritzburg

Sponsors (3)

Lead Sponsor	Collaborator
University of Missouri-Columbia	National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS)

Country where clinical trial is conducted

South Africa, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary: determine safety of L. frutescens when used by HIV-1 infected adults with early disease, and to document disease progression.		24 week treatment period	Yes
Secondary	Secondary: Determine the effect of L. frutescens on quality of life in HIV-1 infected adults, and length of infection.		24 week treatment period	Yes