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
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