Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201208000402280 Date of Approval: 13/08/2012
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title STALEO
Official scientific title The Effect of modified Stavudine and lamivudine containing regimen in antiretroviral therapy on clinical, immunological and virological outcomes in HIV-infected patients in Dar es Salaam, Tanzania. (STALEO TRIAL)
Brief summary describing the background and objectives of the trial Various antiretroviral regimens are being used to-date. However, frequent dosing cause poor adherence, some patients can not follow the twice-daily regimen. Many ARVs are associated with severe include stavudine at a dose of 30mg twice daily. therefore reduction to 30mg once-daily dosing could alleviate stavudine related adverse effects as well as improvement of adherence. Hence prevents development of resistant HIV strains that cause treatment failure. Most developing countries include Tanzan
Type of trial RCT
Acronym (If the trial has an acronym then please provide) STALEO
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Treatment: Other
Anticipated trial start date 07/11/2011
Actual trial start date 07/11/2011
Anticipated date of last follow up 28/02/2014
Actual Last follow-up date 28/02/2014
Anticipated target sample size (number of participants) 520
Actual target sample size (number of participants) 530
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
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STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group New antiretroviral medicine regimen stavudine 30mg once-daily, Lamivudine 300mg once-daily and Efavirenz 600mg nocte once-daily at bed time The intervention group will receive modified regimen onc daily at bed time 260 Active-Treatment of Control Group
Control Group Standard treatment (AZT+3TC+EFV) Zidovudine 300mg b.d+ Lamivudine 150mg b.d+Efavirenz600mg o.d Life long treatment(event after study duration) The control group will receive standnard regiment (AZT+3TC+EFV) 260 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ HIV-infected as documented by positive HIV antibody test. ¿ Subject is at least 18 years of age at the day of the first HIV clinic visits. ¿ Able to give informed consent ¿ CD4+ T lymphocyte count less or equal to 350 cell/mm3 or those indicated for antiretroviral therapy by WHOstaging criterio ¿ Karnofsky score > 40. ¿ Willing and able to regularly attend the HIV clinic at the designated sites. ¿ Patient note exposed to antiretroviral drugs as determined by self reporting. ¿ Women with a negative urinary pregnancy during enrolment ¿ Women expected to bear a child during the study period as determined during initial assessment. ¿ A history of severe psychiatric disease such as psychosis, schizophrenia, depression, ¿ Patient with clinically confirmed neuropathy and lipodystrophy 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/07/2011 MUHAS, Research and Publication Commitee
Ethics Committee Address
Street address City Postal code Country
P.O Box 65001 Dar es Salaam 022 Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome viral load at 24 weeks
Primary Outcome CD4 count at three months interval
Primary Outcome morbidity monthly basis
Primary Outcome adherence mothly basis
Secondary Outcome adverse effects of antiretroviral drugs monthly basis
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Temeke Hospital Temeke Dar es Salaam 022 Tanzania
Amana Hospital Ilala boma Dar es Salaam 022 Tanzania
Mwananyamala Hospital kinondoni Dar es Salaam 022 Tanzania
infectious Disease Clinic (IDC) Rail Station Dar es Salaam 022 Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Muhimbili University of Health and Allied Sciences (MUHAS) through ICORHTA Off United Nations Road Dar es Salaam 022 Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor International Clinical Operations Health Research in Tanzania (ICOHRTA) Off United Nations Road Dar es Salaam 022 Tanzania University
COLLABORATORS
Name Street address City Postal code Country
Harvard University Huntington Ave. Boston 02115 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Deus Buma buma70@yahoo.co.uk +255 757327551 Off United Nations Road
City Postal code Country Position/Affiliation
Dar es Salaam 022 Tanzania Lecturer and PhD Student at Muhimbili University
Role Name Email Phone Street address
Scientific Enquiries Muhammad Bakari drbakari@yahoo.com +255 754 387 328 Off United Nations Road
City Postal code Country Position/Affiliation
Dar es Salaam 022 Tanzania Senior Lecture
Role Name Email Phone Street address
Scientific Enquiries Ferdinand Mugusi fm.mugusi@gmail.com +255786613354 Off United Nations Road
City Postal code Country Position/Affiliation
Dar es Salaam 022 Tanzania Senior Lecturer and My Main Supervisor (A trial is for PhD study)
Role Name Email Phone Street address
Scientific Enquiries Wafaie Fawzi mina@hsph.harvard.edu +1-617- 432-5299 665 Huntington Avenue
City Postal code Country Position/Affiliation
Boston 02115 United States of America Chairperson Global Health Department (My Co- Supervisor)
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information