Condition category
Infections and Infestations
Date applied
27/06/2010
Date assigned
08/07/2010
Last edited
08/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Iris von Hörsten

ORCID ID

Contact details

Eliecer Parada 2030
Providencia
Santiago de Chile
7510931
Chile
irisvh@vtr.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

HIV-Infected Patients with Advanced Disease in treatment with HAART use Complementary Alternative Medicine for Reconstitution of CD4 count and for Improving their Health Related Quality of Life over Time

Acronym

Study hypothesis

To describe if complementary alternative medicine (CAM) improves CD4 count and health related quality of life (HRQOL) in subjects presenting low naïve CD4 count and poor CD4 rise despite of good virologic response on highly active antiretroviral treatment (HAART).

Ethics approval

The ethics commission of the Hospital San Juan de Dios approved the study design in August 2007.

Study design

Single centre longitudinal case-control study

Primary study design

Interventional

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

HIV-Infected Patients with Advanced Disease under HAART

Intervention

The same physician will be in charge of the CAM treatment throughout, indicating treatment, controlling its effects, adjusting therapy and also indicating additional controls with the physician in charge of HIV if needed. The controls in the program are every 2 to 8 weeks.
CAM will combine different therapeutic aspects:
1. All patients receive homeopathy and Bach-Flowers
2. Some cases will receive phytotherapy, consisting of Engystol®, propolis and/or aloe vera
3. Dietary advice, patients to reduce intake of any artificial substances like sweeteners, colourings and preservatives, and also substances like tobacco and alcohol
4. Patients open to body-mind-medicine will be taught a meditation technique by the CAM physician with creative visualization recovering sensations of health, well-being and peace

The homeopathic medicine is applied according the homeopathic constitutional integrated conception (presented in the 7° Congress of the Federation of Medical Homeopathic Argentinean Associations) whose main feature is that the homeopath has to identify the inner conflict of the patient leading to his current condition.

The medication is prepared at all times in the same homeopathic pharmacy under supervision of the same pharmacist. The patient has to fetch his prescription in the pharmacy.

Results are compared with the patient's CD 4 rise before intervention and the expected behaviour of CD 4 rise in these type of patients.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. CD4 cell count and viral load, measured every 3 months
Viral load was considered undetectable with < 80 UI/mL copies using Nuclisens Easy Q HIV-1, Bio Mérieux test
2. Quality of Life, measured by Medical Outcomes Study Short Form 30 (MOS-SF-30) validated for people infected by HIV, answered privately by the patient every 3 months

Secondary outcome measures

1. Incidence of hospitalisation
2. Opportunistic infection
3. Death
4. Side effects of CAM
5. Interaction of HAART and CAM

Overall trial start date

05/06/2007

Overall trial end date

05/06/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Any adult patient infected with HIV who has a naïve CD4 count < 200 cell/mL and who, despite > 48 weeks of HAART, keep CD4 < 250 cell/mL
2. Adherent to HAART and to the controls with the physician in charge of treatment of the HIV-condition
3. Patients who modify their HAART regimens are not excluded if plasma HIV-1 RNA levels, remain < 80 copies/mL

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

15 patients from the Hospital San Juan de Dios, Santiago, Chile

Participant exclusion criteria

Patients who use hydroxyurea, IL-2, IFN-α, or the combination of tenofovir and didanosine, which are known to affect CD4 count increases

Recruitment start date

05/06/2007

Recruitment end date

05/06/2012

Locations

Countries of recruitment

Chile

Trial participating centre

Eliecer Parada 2030, Providencia
Santiago de Chile
7510931
Chile

Sponsor information

Organisation

Hospital San Juan de Dios (Chile)

Sponsor details

c/o Dr Iris von Hörsten
Eliecer Parada 2030
Providencia
Santiago de Chile
7510931
Chile

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Hospital SAn Juan de Dios (Chile) - internal funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Laboratory Heel (Chile) - provides homeopathic medicine and Engystol

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Mr. M Cavieres (Local provider) (Chile) - provides Propolis

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Dr. Iris von Hörsten (Chile) - provides the Bach-Flowers

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes