Contact information
Type
Scientific
Primary contact
Dr Francis Ssali
ORCID ID
Contact details
Plot 893 Ring Road
Butikiro House - Mengo
Kampala
P.O. Box 10005
Uganda
+256 41 270283/270622
ssalifran@yahoo.co.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HS 103
Study information
Scientific title
Acronym
The Wepox study
Study hypothesis
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
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).
Study design
Open label randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/03/2006
Overall trial end date
01/04/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Documented HIV positive
2. Grade 1 and 2 anaemia
3. Informed consent
4. Age 18 to 65 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant 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
Recruitment start date
01/03/2006
Recruitment end date
01/04/2008
Locations
Countries of recruitment
Uganda
Trial participating centre
Plot 893 Ring Road
Kampala
P.O. Box 10005
Uganda
Sponsor information
Organisation
Star Pharmaceuticals Ltd (Uganda)
Sponsor details
Plot 20/3
Jinja Road
Opposite Spear House
Kampala
PO Box 4391
Uganda
+256 41 232863
starpharm@infocom.co.ug
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Star Pharmaceuticals Uganda Ltd (Uganda) - local representative for Wockhardt
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary