Nigeria Clinical Trial Registry Federal Ministry of Health Federal Secretariat Complex Shehu Shagari Way, Garki, Abuja Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836 Email: info@nhrec.ne Trial No: 89519615 Date registered: 2015-03-31 Trial Status: Pending TRIAL DESCRIPTION Public title A Bridging study to Evaluate the Effects of LODONAL as an Immune-System Regulating Agent in Subjects in Which their Immune System is Compromised Official scientific title LODONAL™ IN THE TREATMENT OF SUBJECTS WITH HUMAN IMMUNODEFICIENCY VIRUS (HIV) Brief summary describing the background and objectives of the trial 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. Type of trial Treatment Acronym (If the trial has an acronym then please provide) A Bridging study to Evaluate the Effects of LODONAL as an Immune-System Regulating Agent in Subjects in Which their Immune System is Compromised Disease(s) or condition(s) being studied HIV / Aids Purpose of the trial Anticipated trial start date 2015-04-06 Actual trial start date 2015-04-20 Anticipated date of last follow up 2015-06-26 Actual date of last follow up 2015-07-06 Anticipated target sample size (number of participants) 150    Actual target sample size (number of participants) 150    Recruitment status Open to recruitment: actively recruiting participants No Secondary ID 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 Single group Non-randomised 1 sealed opaque envelopes. 1 Participants,Outcome Assessors,1 INTERVENTIONS Intervention type Intervention name Dose Duration Intervention description Group size Nature of control Control group No intervention or crossover LODONAL 4.5 mg capsules p.o. q.d. before bed for 90 days If there are no side effects and the CD4 counts show an inrease, there might be early termination of study 150 Historical ELIGIBILITY CRITERIA List inclusion criteria List exclusion criteria Min age Max age Gender 1 1 1 1 1 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 0000-00-00 2014-11-26 Osun State Ministry of Health Ethics Committee Address Street address City Postal code Country Asubiaro, Osogbo Osogbo 230222 Nigeria OUTCOMES Type of outcome Outcome Timepoint(s) at which outcome measured Secondary 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. 1. Day 0 2. Day 30 3. Day 60 and 4. Day 90 RECRUITMENT CENTRES Name of recruitment centre Street address City Postal code Country State Specialist Hospital, HIV Clinic, Asubiaro Osogbo 230222 Nigeria FUNDING SOURCES Name of source Street address City Postal code Country TNIB (Immune Therapeutics) Road Town, Tortola British Virgin Islands 3321 United States of America SPONSORS Sponsor level Name Street address City Postal code Country Nature of sponsor COLLABORATORS Name Street address City Postal code Country Dr. Richards Afonja American Hospitals and Resorts, Lekki Lagos 234 Nigeria Dr. Abayomi Akinwale Oni Asubiaro, Osogbo Osogbo 230222 Nigeria CONTACT PEOPLE Role Name Email Phone Fax Principal Investigator Dr Richards Afonja aareonakakanfor@mac.com 2147483647 2147483647 Street address City Postal code Country Position / Affiliation Olaitan Senbajo Lagos 234 Nigeria MD/CEO Scientific Enquiries Dr Richards Afonja aareonakakanfor@mac.com 2147483647 2147483647 Street address City Postal code Country Position / Affiliation Olaitan Senbajo Lagos 234 Nigeria MD/CEO Public Enquiries Ms Joy Anokam joissce@gmail.com 2147483647 2147483647 Street address City Postal code Country Position / Affiliation Lekki Lagos 234 Nigeria Customer Relations