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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Placebo

Placebo (capsule filled with inert materials)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsules containing 0 mg bid (placebo)

Low Dose

400 mg bid Lessertia Frutescens

Group Type EXPERIMENTAL

Low Dose

Intervention Type DRUG

Capsules containing 400 mg bid of L. frutescens.

Mid Dose

800 mg bid Lessertia Frutescens

Group Type EXPERIMENTAL

Mid Dose

Intervention Type DRUG

Capsules containing 800 mg bid of L. frutescens.

High Dose

1200 bid Lessertia Frutescens

Group Type EXPERIMENTAL

High Dose

Intervention Type DRUG

Capsules containing 1200 mg bid of L. frutescens.

Interventions

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Placebo

Capsules containing 0 mg bid (placebo)

Intervention Type DRUG

Low Dose

Capsules containing 400 mg bid of L. frutescens.

Intervention Type DRUG

Mid Dose

Capsules containing 800 mg bid of L. frutescens.

Intervention Type DRUG

High Dose

Capsules containing 1200 mg bid of L. frutescens.

Intervention Type DRUG

Other Intervention Names

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Lessertia Frutescens Sutherlandia Lessertia Frutescens Sutherlandia Lessertia Frutescens Sutherlandia

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No