Complementary Alternative Medicine for Reconstitution of CD4 count and Quality of Life in HIV-Infected Patients with Advanced Disease

ISRCTN ISRCTN03831044
DOI https://doi.org/10.1186/ISRCTN03831044
Secondary identifying numbers N/A
Submission date
27/06/2010
Registration date
08/07/2010
Last edited
08/07/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Iris von Hörsten
Scientific

Eliecer Parada 2030, Providencia
Santiago de Chile
7510931
Chile

Email irisvh@vtr.net

Study information

Study designSingle centre longitudinal case-control study
Primary study designInterventional
Secondary study designCase-control study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleHIV-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
Study objectivesTo 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(s)The ethics commission of the Hospital San Juan de Dios approved the study design in August 2007.
Health condition(s) or problem(s) studiedHIV-Infected Patients with Advanced Disease under HAART
InterventionThe 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 typeOther
Primary outcome measure1. 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 measures1. Incidence of hospitalisation
2. Opportunistic infection
3. Death
4. Side effects of CAM
5. Interaction of HAART and CAM
Overall study start date05/06/2007
Completion date05/06/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants15 patients from the Hospital San Juan de Dios, Santiago, Chile
Key inclusion criteria1. 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
Key exclusion criteriaPatients who use hydroxyurea, IL-2, IFN-α, or the combination of tenofovir and didanosine, which are known to affect CD4 count increases
Date of first enrolment05/06/2007
Date of final enrolment05/06/2012

Locations

Countries of recruitment

  • Chile

Study participating centre

Eliecer Parada 2030, Providencia
Santiago de Chile
7510931
Chile

Sponsor information

Hospital San Juan de Dios (Chile)
Hospital/treatment centre

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

ROR logo "ROR" https://ror.org/03mt12903

Funders

Funder type

Hospital/treatment centre

Hospital SAn Juan de Dios (Chile) - internal funding

No information available

Laboratory Heel (Chile) - provides homeopathic medicine and Engystol

No information available

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

No information available

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan