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
Protocol serial number	HS 103
Sponsor	Star Pharmaceuticals Ltd (Uganda)
Funder	Star Pharmaceuticals Uganda Ltd (Uganda) - local representative for Wockhardt

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

Plot 893 Ring Road
Butikiro House - Mengo
Kampala
P.O. Box 10005
Uganda

Phone	+256 41 270283/270622
Email	ssalifran@yahoo.co.uk

Study information

Primary study design	Interventional
Study design	Open label randomised trial
Secondary study design	Randomised controlled trial
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(s)	Change in haemoglobin, measured at week 0 and end of week 4.
Key secondary outcome measure(s)	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
Completion date	01/04/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Results and Publications

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