Trial No: Date registered: Trial Status: Pending TRIAL DESCRIPTION

Transcription

1 Nigeria Clinical Trial Registry Federal Ministry of Health Federal Secretariat Complex Shehu Shagari Way, Garki, Abuja Telephone: / Fax: info@nhrec.ne Public title Official scientific title Brief summary describing the background and objectives of the trial Type of trial Treatment Acronym (If the trial has an acronym then please provide) Disease(s) or condition(s) being studied Purpose of the trial trial start date Actual trial start date Trial No: Date registered: Trial Status: Pending TRIAL DESCRIPTION A Bridging study to Evaluate the Effects of LODONAL as an Immune-System Regulating Agent in Subjects in Which their Immune System is Compromised LODONAL IN THE TREATMENT OF SUBJECTS WITH HUMAN IMMUNODEFICIENCY VIRUS (HIV) The primary objective of this clinical trial is to To confirm that LODONAL has a beneficial effect on the immune system of patients in Nigeria with a compromised immune system (refer to Inclusion/Exclusion Criteria). This will be determined by: The number of subjects with CD4 count stabilization (less than 10% change from baseline mean values) or 25% increase in CD4 counts on LODONAL compared to observation group from baseline to Days 30, 60 and 90. A Bridging study to Evaluate the Effects of LODONAL as an Immune-System Regulating Agent in Subjects in Which their Immune System is Compromised HIV / Aids Page 1 of 5

2 date of last follow up Actual date of last follow up target sample size (number of participants) Actual target sample size (number of participants) Recruitment status Open to recruitment: actively recruiting participants No Secondary ID Issuing authority/trial register assignment Single group Allocation to intervention If randomised, describe how the allocation sequence was generated Nonrandomised Nonrandomised bridging trial STUDY DESIGN Describe how the allocation sequence/ was concealed from the person allocating the participants to the intervention arms It is not concealed.it is an open an open nonrandomised, non-blinded trial Masking Open-label (masking not used) If masking / blinding was used,, type Control group name No intervention or crossover INTERVENTIONS Dose Duration description LODONAL 4.5 mg capsules p.o. q.d. before bed If there are no side effects and the CD4 counts show an inrease, there might be early Group size Nature of control 150 Historical Page 2 of 5

3 for 90 days termination of study ELIGIBILITY CRITERIA List inclusion criteria List exclusion criteria Min age 1. Provide written informed consent prior to any study-required screening procedures. 2. Male or female adult subjects years of age. 3. Mean CD4 levels between 80 and 600 cell/mm3 checked 1. Women of childbearing potential unless surgically sterile or using adequate contraception (either IUD, oral or depot contraceptive, or barrier plus spermicide), and willing and able to continue the Max age Gender Both Has the study received appropriate ethics committee Date the study will be submitted for ETHICS APPROVAL Date of Name of the ethics committee Osun State Ministry of Health Street address Ethics Committee Address City Postal Asubiaro, Osogbo Osogbo Nigeria Type of outcome Secondary Outcome OUTCOMES Outcome Primary outcome is to show that the drug is safe to use in patients. Secondary outcome is to show an increase in CD4 count from baseline. Timepoint(s) at which outcome measured 1. Day 0 2. Day Day 60 and 4. Day 90 Name of recruitment centre State Specialist Hospital, HIV Clinic, RECRUITMENT CENTRES Street address City Postal Asubiaro Osogbo Nigeria Page 3 of 5

4 FUNDING SOURCES Name of source Street address City Postal TNIB (Immune Therapeutics) Road Town, Tortola British Virgin Islands 3321 United States of America Sponsor level SPONSORS Name Street address City Postal Nature of sponsor COLLABORATORS Name Street address City Postal Dr. Richards Afonja Dr. Abayomi Akinwale Oni American Hospitals and Resorts, Lekki Lagos 234 Nigeria Asubiaro, Osogbo Osogbo Nigeria CONTACT PEOPLE Role Name Phone Fax Principal Investigator Dr Richards Afonja Street address City Postal Position / Olaitan Senbajo Lagos 234 Nigeria MD/CEO Scientific Enquiries Dr Richards Afonja aareonakakanfor@mac.com Street address City Postal Position / Olaitan Senbajo Lagos 234 Nigeria MD/CEO Public Enquiries Ms Joy Anokam Street address City Postal joissce@gmail.com Position / Lekki Lagos 234 Nigeria Customer Relations Page 4 of 5

5 Page 5 of 5