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.: PACTR201007000226131 Date of Approval: 20/06/2010
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title COMPARISM BETWEEN ONCE DAILY AND TWICE DAILY LPV/RTR CO-ADMINISTERED WITH TENOFOVIR AND EMTRICITOBIN AMONG HIV INFECTED PATIENTS DURING MUSLIM RAMADAN
Official scientific title COMPARISM BETWEEN ONCE DAILY AND TWICE DAILY LPV/RTR CO-ADMINISTERED WITH TENOFOVIR AND EMTRICITOBIN AMONG HIV INFECTED PATIENTS DURING MUSLIM RAMADAN FASTING.
Brief summary describing the background and objectives of the trial Annual Ramadan fasting (FT) is a fundamental pillar of Islam. During this month, drinking and eating are limited to the hour before sunrise and the hour after sunset. Many countries with considerable burden of human immunodeficiency virus(HIV) Infection in Africa and Asia also have substantial number of Muslim populations.1 Physicians find themselves presented with special health care challenges during Ramadan. The M05-730 Study compares Once daily(QD) and twice daily(BID) dosing of LPV/r.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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: Drugs
Anticipated trial start date 20/07/2010
Actual trial start date 20/07/2010
Anticipated date of last follow up 30/09/2010
Actual Last follow-up date 30/09/2010
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 a randomisation table from a statistic book. Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised simple randomisation using a randomisation table from a statistic book. Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised simple randomisation using a randomisation table from a statistic book. Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised simple randomisation using a randomisation table from a statistic book. Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Lopinavir/Ritonavir 400mg/100mg, twice daily 10 weeks ARV 50 Dose Comparison
Experimental Group Lopinavir/Ritonavir 800mg/200mg once daily 10 weeks ARV 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-age above 18 years - clinically stable -patint should be on Tenofovir + Emtricytobin+ Lopinavir/ritonavir. -patient that consented. -Less than 18 year -patient on other ARV regimen -patient that refuse to consent. 18 Year(s) 70 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
No 01/07/2010 Aminu Kano Teaching Hospital Ethical Committee
Ethics Committee Address
Street address City Postal code Country
No. 3 Hospital road, off Zaria road Kano. Kano +234 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Tolerability(Presence or Abscence of adverse drug effects) At 0 and at 6 to 10 weeks
Primary Outcome Laboratory monitoring(Lipid profile, Kidney function test, haematocrit) At 0 and at 6 to 10 weeks
Secondary Outcome Effectiveness(Viral load, CD4 count) At 0 and at 6 to 10 weeks
Primary Outcome Therapeutic drug monitoring At about middle of the study.
Primary Outcome Adherence At 0 and at 6 to 10 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
SS Wali Virology Center, Aminu Kano Teaching Hospital-Kano No. 3 Hospital road, off Zaria road Kano Kano +234 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Institute of human virology, Kano region -Nigeria No. 3 Hospital road, off Zaria road Kano Kano +234 Nigeria
Institute of human virology, Kano region -Nigeria No. 3 Hospital road, off Zaria road Kano Kano +234 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr, Habib A. G. Department of Medicine AKTH, Kano Kano +234 Nigeria Charities/Societies/Foundation
Primary Sponsor Dr, Habib A. G. Department of Medicine AKTH, Kano Kano +234 Nigeria Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Institute of human virology, Kano region -Nigeria No.3 Hospital road, off zaria road Kano Kano +234 Nigeria
Institute of human virology, Kano region -Nigeria No.3 Hospital road, off zaria road Kano Kano +234 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator AG Habib abdulrazaq_habib@yahoo.co.uk +2348036921712 Dept. of Medicine AKTH, Kano
City Postal code Country Position/Affiliation
Kano 234 Nigeria Associate Professor/ Consultant physician Infectious and Tropical Diseases
Role Name Email Phone Street address
Public Enquiries Muhammad Hamza drhamza1020@ymail.com +2348035053139 Dept. of Medicine AKTH, Kano
City Postal code Country Position/Affiliation
Kano 234 Nigeria Senior registrar Infectious and Tropical Diseases
Role Name Email Phone Street address
Scientific Enquiries AM Yakasai amyakasai@yahoo.com +2348065419097 Dept. of Medicine AKTH, Kano
City Postal code Country Position/Affiliation
Kano 234 Nigeria Senior registrar Infectious and Tropical Diseases
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information