|
ISRCTN
|
ISRCTN03831044
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Complementary Alternative Medicine for Reconstitution of CD4 count and Quality of Life in HIV-Infected Patients with Advanced Disease
|
|
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
|
N/A
|
|
Serial number at source
|
N/A
|
|
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
|
|
Countries of recruitment
|
Chile
|
|
Disease/condition/study domain
|
HIV-Infected Patients with Advanced Disease under HAART
|
|
Participants - 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
|
|
Participants - 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
|
|
Anticipated start date
|
05/06/2007
|
|
Anticipated end date
|
05/06/2012
|
|
Status of trial
|
Ongoing |
|
Patient information material
|
Not available in web format, please use contact details below to request a patient information sheet
|
|
Target number of participants
|
15 patients from the Hospital San Juan de Dios, Santiago, Chile
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
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 measure(s)
|
1. Incidence of hospitalisation
2. Opportunistic infection
3. Death
4. Side effects of CAM
5. Interaction of HAART and CAM
|
|
Sources of funding
|
1. Hospital SAn Juan de Dios (Chile) - internal funding
2. Laboratory Heel (Chile) - provides homeopathic medicine and Engystol
3. Mr. M Cavieres (Local provider) (Chile) - provides Propolis
4. Dr. Iris von Hörsten (Chile) - provides the Bach-Flowers
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Iris
von Hörsten
|
|
Address
|
Eliecer Parada 2030, Providencia
|
|
City/town
|
Santiago de Chile
|
|
Zip/Postcode
|
7510931
|
|
Country
|
Chile
|
|
Email
|
irisvh@vtr.net
|
|
Sponsor
|
Hospital San Juan de Dios (Chile)
|
|
Address
|
c/o Dr Iris von Hörsten
Eliecer Parada 2030
Providencia
|
|
City/town
|
Santiago de Chile
|
|
Zip/Postcode
|
7510931
|
|
Country
|
Chile
|
|
Date applied
|
27/06/2010
|
|
Last edited
|
08/07/2010
|
|
Date ISRCTN assigned
|
08/07/2010
|
