Effects of V.II-BE on the number of circulating virus particles and immune cells in the blood in patients diagnosed positive with HIV
| ISRCTN | ISRCTN83581730 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83581730 |
| Secondary identifying numbers | GHS-0312/kl |
- Submission date
- 27/09/2012
- Registration date
- 08/10/2012
- Last edited
- 06/06/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
We were carrying out this study in order to measure the effect of an herbal
preparation containing a special extract of the medicinal plants chamomile, rose, lavender,
myrrh, willow bark and spiny rush on HIV infection. The aim is to
test the potential of the herbal preparation for an improvement in virus load and immune cells
in patients diagnosed as HIV positive but not yet eligible for treatment with antiviral
medications. This situation, where the patient cannot receive medication because the risk of
adverse effects and formation of resistance, can be considered a therapeutic gap, leaving the
patient on his/her own with a dreadful perspective. A well-tolerated herbal preparation contributing
to controlling the virus load and the immune status in the early stages of an HIV infection is
expected to increase the quality of life of the patients, and delay the aggravation of the
response of the immune system even to minor threats.
Who can participate?
Adults up to the age of 50 diagnosed with HIV who have a virus load and CD4-cell count below
the threshold for the prescription of an antiviral medical treatment.
What does the study involve?
Within the study, only routine examination results are documented, as they would have been
obtained from regular medical supervision. In addition, the typical laboratory blood
examinations on liver and kidney function and blood lipids are documented as an additional
safety aspect. The study is designed for an observation period of 3 months.
What are the possible benefits and risks of participating?
A delay of the requirement of antiviral treatment is a major clinical achievement in HIV
treatment: it increases the quality of life of HIV patients, and postpones the risk of resistance
formation against antiviral medications, as well as the risk of adverse effects. In previous examinations and experience with exposure to the herbal preparation, no adverse reactions have been observed. Participating patients are screened for potential adverse events.
Where is the study run from?
The study is run from clinical HIV healthcare centres.
When is the study starting and how long is it expected to run for?
The study started in 2012 and is expected to finish in the same year.
Who is funding the study?
Funding has been provided by GHS AG in Liechtenstein, a company financially supporting the
development of the herbal preparation by its inventor, Mrs Monica Volkmar.
Who is the main contact?
Dr Mathias Schmidt
schmidt@herbresearch.de
Contact information
Scientific
Dorotheergasse 7
Wien
1010
Austria
| Phone | +43 1 5130607 |
|---|---|
| ordination@imhof.at |
Study information
| Study design | Open prospective study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Documentation of the clinical effect and safety of V.II-BE on immunological parameters of HIV-infected patients: an open prospective trial |
| Study objectives | The intake of the herbal preparation V.II-BE contributes to lowering the virus load and increases the number of circulating CD4 cells in patients infected with human immunodeficiency virus (HIV), but still not sufficiently diseased to be eligible for treatment with antiviral medication. |
| Ethics approval(s) | Ethics Committee of the study centre in Cluj, Romania, 28/05/2012 |
| Health condition(s) or problem(s) studied | HIV at a stage where antiviral treatment is not yet recommended according to medical guidelines |
| Intervention | All patients receive the V.II-BE solution (special extract of the medicinal plants chamomile, rose, lavender, myrrh, willow bark and spiny rush). The product contains 90% ethanol. The recommended dose is 60 drops twice daily with a little water for 3 months. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | V.II-BE (herbal preparation) |
| Primary outcome measure | Virus load and CD4 cell count |
| Secondary outcome measures | Safety laboratory values |
| Overall study start date | 01/06/2012 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30-40 |
| Key inclusion criteria | 1. Patients up to the age of 50 diagnosed with an HIV infection 2. Virus load below 50,000 copies/ml of blood 3. CD4 cell count above 350 cells/µl of blood 4. Stable virus load for the past 6 months |
| Key exclusion criteria | Patients cannot be included if: 1. They receive antiviral medication 2. They are treated with antibiotics 3. They undergo chemotherapy for cancer treatment 4. They have a background of abusing alcohol or illicit drugs 5. They have a co-infection with hepatitis 6. They are, in the case of women, pregnant or lactating |
| Date of first enrolment | 01/06/2012 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- Austria
- Romania
Study participating centre
1010
Austria
Sponsor information
Industry
Letzanaweg 23
POB 20
Triesen
FL-9495
Liechtenstein
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
