A pilot study on the use of low dose erythropoietin in the management of human immunodeficiency virus (HIV) associated anaemia in Uganda
| ISRCTN | ISRCTN40084595 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40084595 |
| Secondary identifying numbers | HS 103 |
- Submission date
- 20/06/2007
- Registration date
- 06/08/2007
- Last edited
- 02/09/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
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 Francis Ssali
Scientific
Scientific
Plot 893 Ring Road
Butikiro House - Mengo
Kampala
P.O. Box 10005
Uganda
| Phone | +256 41 270283/270622 |
|---|---|
| ssalifran@yahoo.co.uk |
Study information
| Study design | Open label randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | The Wepox study |
| Study objectives | Erythropoietin is efficacious in improving the haemoglobin among anaemic HIV+ individuals at a lower than the currently recommended dose of 40,000 IU per week or 100 - 300 IU/Kg three times per week. |
| Ethics approval(s) | Ethics approval received from: 1. Ethics committee of the Faculty of Medicine, Makerere University on 29th December 2005. Renewed on the 23rd April 2007 and will expire on 23rd October 2007. 2. Uganda National Council for Science and Technology (UNCST) on 18th January 2006. Renewed on the 10th May 2007 and will expire on the 13th April 2008 (ref: HS103). |
| Health condition(s) or problem(s) studied | HIV associated anaemia |
| Intervention | Each participant will be randomised to one of the following four groups: 1. Intervention group 1: Haematinics (one capsule orally once daily) and erythropoietin (Wepox) 2000 IU three times per week subcutaneously for 4 weeks 2. Intervention group 2: Haematinics (one capsule orally once daily) and erythropoietin (Wepox) 4000 IU once a week subcutaneously for 4 weeks 3. Intervention group 3: Haematinics (one capsule orally once daily) and erythropoietin (Wepox) 2000 IU once a week subcutaneously for 4 weeks 4. Control group: Haematinics (one capsule orally once daily) for 4 weeks The haematinic capsule contains 305 mg ferrous fumarate equivalent to 100 mg elemental iron, 0.75 mg folic acid, 5 micrograms cyanocobalamin, 75 mg ascorbic acid and 5.0 mg zinc sulphate. Interim analysis of this study will be carried out in July 2007. Final evaluation of the study will be carried out on completion of the study enrolment and follow-up, but the latter may be influenced by the results of the interim analysis. |
| Intervention type | Other |
| Primary outcome measure | Change in haemoglobin, measured at week 0 and end of week 4. |
| Secondary outcome measures | 1. Quality of life improvement, measured at week 0 and end of week 4 using a visual analogue scale (LASA) and the Medical Outcomes Study HIV Health Survey (MOSHIV) instrument 2. Adverse events |
| Overall study start date | 01/03/2006 |
| Completion date | 01/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | 1. Documented HIV positive 2. Grade 1 and 2 anaemia 3. Informed consent 4. Age 18 to 65 years |
| Key exclusion criteria | 1. Recent blood loss 2. Active opportunistic infection 3. Presence of fever at the time of enrolment 4. Pregnancy 5. Cancer chemotherapy 6. Severe microcytosis 7. Systemic hypertension 8. Known allergy to erythropoietin |
| Date of first enrolment | 01/03/2006 |
| Date of final enrolment | 01/04/2008 |
Locations
Countries of recruitment
- Uganda
Study participating centre
Plot 893 Ring Road
Kampala
P.O. Box 10005
Uganda
P.O. Box 10005
Uganda
Sponsor information
Star Pharmaceuticals Ltd (Uganda)
Industry
Industry
Plot 20/3
Jinja Road
Opposite Spear House
Kampala
PO Box 4391
Uganda
| Phone | +256 41 232863 |
|---|---|
| starpharm@infocom.co.ug | |
| Website | http://www.staruganda.com |
Funders
Funder type
Industry
Star Pharmaceuticals Uganda Ltd (Uganda) - local representative for Wockhardt
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 |
