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
Scientific
Eliecer Parada 2030, Providencia
Santiago de Chile
7510931
Chile
| irisvh@vtr.net |
Study information
| Study design | Single centre longitudinal case-control study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient 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 | 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 study start date | 05/06/2007 |
| Completion date | 05/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 15 patients from the Hospital San Juan de Dios, Santiago, Chile |
| 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
7510931
Chile
Sponsor information
Hospital San Juan de Dios (Chile)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr Iris von Hörsten
Eliecer Parada 2030
Providencia
Santiago de Chile
7510931
Chile
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
