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
Protocol serial number	N/A
Sponsor	Hospital San Juan de Dios (Chile)
Funders	Hospital SAn Juan de Dios (Chile) - internal funding, Laboratory Heel (Chile) - provides homeopathic medicine and Engystol, Mr. M Cavieres (Local provider) (Chile) - provides Propolis, Dr. Iris von Hörsten (Chile) - provides the Bach-Flowers

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

Primary study design	Interventional
Study design	Single centre longitudinal case-control study
Secondary study design	Case-control study
Study type	Participant information sheet
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
Study objectives	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(s)	The ethics commission of the Hospital San Juan de Dios approved the study design in August 2007.
Health condition(s) or problem(s) studied	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
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
Key secondary outcome measure(s)	1. Incidence of hospitalisation 2. Opportunistic infection 3. Death 4. Side effects of CAM 5. Interaction of HAART and CAM
Completion date	05/06/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	15
Key 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
Key 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
Date of first enrolment	05/06/2007
Date of final enrolment	05/06/2012

Locations

Countries of recruitment

Chile

Study participating centre

Eliecer Parada 2030, Providencia

Santiago de Chile
7510931
Chile

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes